101. When applying for the second type of active medical device product to change registration and add a model, under what circumstances can the test report of the original model be covered and under what circumstances must the test be carried out？

　　A: First of all, confirm whether the added model and the original model can be used as the same registration unit, if it can be used as the same registration unit, you can apply to change the registration and add the model。In the absence of new standards，The judgment principle of typical type shall be followed，If the original model can represent the new model，There is no need to repeat the detection;If new standards are involved，The new model needs to provide a test report for the new standard;For example, some items in the original model test report can represent the new model test，This part does not need to be checked again。

　　102.For medical device products whose management category is adjusted from the third category to the second category，Its product registration certificate is also the third type of product registration certificate，If the product has undergone changes in the Medical Device Registration and Filing Management Measures that require change in registration，Can directly apply for change registration with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the residence is located？

　　Answer: In this case, it is not possible to apply for change registration directly to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the residence is located, but it is necessary to apply for change registration formalities at the original registration department。

　　103.In the product technical requirements of the second type of active medical device products, what problems should be paid attention to in the writing process of "Product model/specification and its division description"？

　　A: According to the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, the product technical requirements should specify the product model and/or specifications, as well as the description of their division。The product model/specification and its division description should generally clarify the structure and composition of the product, and for products with multiple models and/or specifications in the same registration unit, all the differences between the models and specifications should be clarified, and the corresponding illustrations can be attached if necessary。A larger description of the model/specification can be provided in appendix form。

　　For independent software or products containing software components, the name, model specifications, release version, and naming rules for the full version of the software should also be clear, and the operating environment (including hardware configuration, software environment and network conditions) of the control software components should also be clear.。

　　104.Which medical devices are applicable to the Medical Device Network Security Registration Review Guidelines？

　　A: The Guiding Principles for the Review of Medical Device Network Security Registration apply to the registration and declaration of medical device network security，Including II and III independent software with one or more of the three functions of electronic data interchange, remote access and control, and user access, and medical devices containing software components (including in vitro diagnostic medical devices);Applicable to self-developed software, off-the-shelf software registration。

　　其中，Networks include wireless and wired networks，Electronic data interchange includes unidirectional and bidirectional data transmission based on network and storage media，Remote access and control includes network-based real-time and non-real-time access and control，Access by users (such as medical staff, patients, maintenance personnel, etc.) includes human-computer interaction based on software user interfaces and electronic interfaces。

　　105.For product technical requirements that do not involve or partially involve national standards, industry standards for inspection and issuance of reports, there is no CMA chapter, how to prove the report compliance？

　　A: According to the provisions of the "Notice of the General Department of the State Food and Drug Administration on clarifying the matters related to the" Medical device Inspection Work Standard "labeling qualification identification mark (2020) No. 746) : The product technical requirements do not involve or partially involve national standards and industry standards for inspection and issuance of reports，The inspection ability should be self-declared in the remarks of the inspection report，And bear the corresponding legal responsibility。The content of the self-declaration is "The technical requirements of the product do not involve/partially involve national standards and industry standards, and cannot be directly used as the basis for qualification certification, but the laboratory has the corresponding inspection ability for the inspection items involved in the report".。

　　106.The second type of active medical device products need to be tested together with passive accessories in the product composition when conducting electromagnetic compatibility testing？

　　A: Usually the equipment device used in the electromagnetic compatibility test, cable layout and all accessories in the typical configuration should be consistent with normal use。If the analysis determines that the passive attachment is not relevant to the EMC test, it does not need to be tested together with the passive attachment。If a passive attachment must be used in the test to achieve its basic performance, the passive attachment should be used in the test。

　　107.How should software differences be considered in the clinical evaluation of the second type of active medical device product with software by comparison with the same variety？

　　A: When comparing, the registration applicant should describe in detail all differences related to the software and analyze whether the differences have an impact on the safety and effectiveness of the product。If necessary, clinical/non-clinical data of the declared product itself should be submitted to demonstrate that the discrepancy does not adversely affect safety and efficacy。

　　108.The second type of active medical device product contains a number of modules, each of which is a product in the List of Medical Devices Exempt from Clinical Evaluation, and whether the combined product can also be regarded as a product in the List？

　　A: If the applicant can prove that the combination of the two does not interact, and the clinical use does not exceed the scope of the exemption catalogue, it can be considered as a simple combination of two exempted products, and the two modules are evaluated separately according to the clinical evaluation requirements of the products in the Catalogue, and the applicant must evaluate the possible risks caused by the combination of modules。

　　109.Do the Medical Device Network Security Registration Review Guidelines apply only to the scope of network security？Whether to consider information security and data security？

　　A: The definition and scope of information security, network security and data security have their respective focuses，There are both connections and differences，Not the same，However, the guidelines do not strictly distinguish the three from the perspective of safety and effectiveness evaluation of medical devices，Unified use of network security expression，That is, from the perspective of network security, the information security and data security of medical devices are comprehensively considered。

　　110.How to determine the basic performance of the product in the immunity test of electromagnetic compatibility testing？

　　A: Basic performance refers to the required performance，When the manufacturer determines the basic performance of the product，The following aspects should be considered, but are not limited to: Analysis of clinical safety risks，Consider performance related to diagnosis/treatment/care，Whether the performance of various sensors, cables, application parts, control devices, display devices, moving parts, etc. is affected by electromagnetic interference。

　　The basic performance identified by the random file should be used as the basic performance for immunity test。If basic performance is not identified in the random file, all functions should be considered as basic performance for immunity testing。

　　111.How to collect, evaluate and analyze the clinical data of the same kind of medical devices？

　　A: Clinical data of the same variety of medical devices should be legally obtained, including clinical literature data, clinical experience data and clinical trial data。To fully identify the types and extent of clinical risks of the declared products，Accurately characterize its clinical performance, effectiveness, clinical benefit and industry level，The registration applicant shall comply with the principles and requirements put forward in the Technical Guidelines for Clinical Evaluation of Medical Devices，Collect, evaluate and analyze clinical data of medical devices of the same variety。

　　112.For the second type of active medical device product, a component in the product structure is a non-medical device, and whether the component can be reflected in the structural composition of the product registration certificate？Whether the component needs to be tested？A: For product components that are not managed as medical devices, they cannot be declared and registered separately, but they can be used as part of medical devices。

　　If the part is declared as a part of the medical device, it should be regarded as part of the whole evaluation, the part should be accompanied by the corresponding detection and verification of the whole machine。If the applicant does not test and verify the part together with the whole machine, it cannot be approved as a part of the product。For example: computers, printers, carts, cable lines, endoscope lighting optical cables, neutral electrode connection lines, etc., all belong to this situation。

　　113.How is the switching direction of the second type of active equipment specified？

　　A: GB9706.1中57.Chapter 1 requires that the main power switch of the second type of active equipment and the main power switch of the control machine should conform to the direction of GB4205, open up and close down, and open left and right。Other switches, such as the standby switch on a computer, do not have this requirement。

　　114.The electrical components do not change when the second type of active medical device product is changed, and other changes occur, such as changes in the shell structure, changes in the overall sealing performance of the device, etc., whether electrical safety and electromagnetic compatibility testing can be exempted？

　　A: The overall evaluation of the changes in the declared products should be carried out. If the changes in the shell structure and sealing performance involve some changes in the electrical safety standards/electromagnetic compatibility standards, and need to be re-judged or evaluated, it should be tested。

　　115.Second type of active medical device product key component supplier changes need to change registration？

　　A: If the key component supplier has been specified in the product technical requirements，Suppliers need to apply for change registration;If not specified in the product technical requirements，No change registration is required，However, it should be controlled in accordance with the requirements of the quality management system，Risk analysis of related design changes，Take measures where necessary to reduce risk to acceptable levels。

　　116.For the second type of active medical device products used with computers, the computer configuration needs to be described in the product technical requirements. How should it be described to avoid frequent change registration due to frequent changes in computer configuration？

　　A: When the computer configuration is described in the product technical requirements, such as CPU frequency, storage space, memory space, display resolution, etc., the minimum configuration requirements can be described。Changes in computer configuration that do not involve changes in product technical requirements may not be registered, but shall be controlled in accordance with the requirements of the quality management system to verify relevant design changes。

　　117.The second type of active medical device product color change need to change the registration？

　　A: If the registration certificate and its attachments do not indicate the color of the product, there is no need to change the registration, and the enterprise should do the relevant work in accordance with its own quality management system requirements。If the color of the product is stated in the registration certificate and its attachments, it is necessary to change the registration。

　　118.The second type of active equipment is used with software, and the equipment and software have separate registration certificates, and the name and release version number of the software are clearly defined in the registration certificate of the equipment。If the software release version has been registered for change after the upgrade, can the software release version in the device registration certificate be directly changed to the new version during the renewal？Whether to apply for registration change？

　　A: The release version number of the software used with the device is specified in the device registration certificate and cannot be changed when the registration is renewed。If the device is to be used with the changed version of the software, it should apply for change registration, and demonstrate the safety and effectiveness of the combined use during the change registration.If no changes are made, the device cannot work with the new version of the software, but it can still work with the software of the previous version。

　　119.Is AI medical software necessarily a Category 3 medical device？

　　A: No，For artificial intelligence medical software whose algorithms have low maturity in medical applications (meaning that they are not on the market or their safety and effectiveness have not been fully proven)，If used to aid decision making，For example, it provides clinical diagnosis and treatment suggestions such as identification of lesion characteristics, determination of lesion nature, medication guidance, and formulation of treatment plan，Management in accordance with Class III medical devices;If used for unassisted decision making，Provide clinical reference information such as data processing and measurement，Management in accordance with Class II medical devices。

　　120.What are the issues that should be concerned about the disinfection and sterilization data of reusable accessories in the second type of active medical device products？

　　A: Reusable accessories should be sterilized or sterilized before use。The instructions should specify the specific disinfection/sterilization method (e.g. disinfectant used, disinfection or sterilization equipment), the important parameters of the disinfection/sterilization cycle (e.g. time, temperature, pressure, etc.)。The research data should provide the basis for determining the disinfection/sterilization method, the confirmation data of the disinfection/sterilization effect and the research data on the tolerance of the recommended disinfection/sterilization method。

　　121.The new registration certificate after the renewal of registration has not taken effect, at this time, it is necessary to change the registration or change the record, which registration certificate should be used for change？

　　A: Changes should be made using the registration certificate within the validity period of the registration certificate。

　　122.How to write "Product Overview" and "Main evaluation Content of product safety and effectiveness" when applying for extended registration of active products？

　　A: The "Product Overview" suggests that: working principle or mechanism of action;Scope of application;Structure composition;Registration number and validity period。

　　In the "Main evaluation contents of product safety and effectiveness", it is recommended to state:

　　(1) The product has not changed during the renewal registration process;

　　(2) If the product changes within the validity period of this registration certificate, the change time and change matters should be clearly defined;

　　(3) If there are new mandatory standards for medical devices issued and implemented within the validity period of this medical device registration certificate, changes made to meet the new mandatory standards for medical devices;

　　(4) If the continuation of registration is a product with an adjustment of the registration management category, the management category adjustment document shall be indicated, and the management category before adjustment and the management category after adjustment shall be clearly defined;

　　(5) If the continuation of registration is a product with adjusted classification code, the classification code adjustment file shall be indicated, and the classification code before adjustment and the classification code after adjustment shall be clearly defined;

　　(6) If the original medical device registration certificate contains matters requiring continued completion, the completion of matters should be explained;

　　(7) Summarize and state the safety and effectiveness of the extended registration product and whether it meets the requirements for extended registration。

　　123.What physical properties should be included in the technical requirements for disposable abdominal piercers？

　　A: The technical requirements for disposable abdominal piercers shall include the relevant performance applicable to YY/T 1710 Disposable Abdominal Piercers，If the structure of the product is different from the design structure of YY/T 1710，Or there are other design elements based on the structure given by YY/ T1710，Related performance requirements should be established，For example, the leakage rate of the puncture device designed with an air seal pressure barrier, the mating performance of the transparent tip of the puncture rod and the laparoscope (if applicable), the performance of the fixed device (if any), the performance of the safety protective cover (if any), the performance of the liquid absorbing component (if any), etc。

　　124.What chemical properties should be included in the technical requirements for disposable abdominal piercers？

　　A: Including but not limited to: turbidity and color of the extract;Reducing substance, heavy metal content, pH, evaporation residue;Ethylene oxide residue (if applicable);If there is a coating, it is necessary to determine the coating performance;For components containing absorbent liquids, properties related to absorbent dissolution must be specified。

　　125.How to submit evaluation data for non-clinical catalog products？

　　A: According to the "Technical Guidelines for Product Comparison Description in the List of Medical Devices Exempt from Clinical Evaluation"，For products listed in the "List of Medical Devices Exempt from Clinical Evaluation" (hereinafter referred to as the "Catalogue")，The applicant for registration shall submit the comparative data of the relevant information of the declared products and the contents described in the Catalogue and the comparative description of the declared products and the medical devices in the Catalogue that have been approved for domestic registration。Specific information requirements to be submitted are as follows:

　　(a) to submit the relevant information of the declared products and the contents of the Catalog comparison data;

　　(b) To submit a comparison between the declared product and the medical device that has been approved for domestic registration in the Catalogue, the comparison shall include the Comparison table between the declared product and the medical device that has been approved for domestic registration in the catalogue and corresponding supporting information。If, after comparison, there is a difference between the declared product and the compared product, analysis and research data on the impact of the difference on safety and effectiveness should also be submitted。The difference between the two should not give rise to different safety and effectiveness issues, that is, the declared product does not have a problem that does not exist in the comparison product and may cause significant risks and/or cause significant impact on effectiveness。

　　The above information submitted should be able to prove that the declared products are basically identical with the products described in the Catalogue。If it cannot be demonstrated that the declared product is substantially identical to the product described in the Catalogue, clinical evaluation should be carried out。

　　126.Does the desensitization agent need to specify the product composition in the technical requirements？

　　A: It is recommended to list the name and content of each component in the product technical requirements model specifications and division instructions, and the sum of the proportion of each component should be 100%。

　　127.How to divide the registration units of desensitizers？

　　A: The desensitizer registration unit is divided according to the technical principle, structural composition, performance index and scope of application of the product in principle, for example: the product mechanism is different, it is recommended not to be declared as the same registration unit;The main components of the products are different, it is recommended not to be declared as the same registration unit。

　　128.How to select the typical model of the prepuce cutting stapler？

　　A: The sample taken by the prepuce cutting stapler should be able to cover the performance indicators of all the products of the registered unit, and the products with different composition materials and structural properties are recommended to select the typical models respectively for difference testing。For example, if the nail material is different, such as titanium and stainless steel, the typical product should be selected in the product of the same material for inspection。

　　129.Whether the circumcision stapler anastomosis nail is exempt from biological experiment？

　　A: At present, titanium, titanium alloy or pure tantalum and stainless steel materials are mostly used for prepuce cutting stapler anastomotic nails。The fitting nails should generally be made of pure titanium or titanium alloy material that meets the chemical composition requirements of GB/T13810, or pure tantalum material that meets the chemical composition requirements of YY/T0245 and ISO13782, or GB4234.1 in the chemical composition requirements of stainless steel material。For anastomotic nails made of the above materials, biological tests can be exempted, and the proof data of anastomotic nail composition will be used as part of the biocompatibility evaluation research data。Use other materials (such as other stainless steel materials, other metal materials) or surface modified treatment of pure titanium, titanium alloy, pure tantalum and other anastomotic nails，The biocompatibility evaluation of the nail should be carried out according to GB/T16886 "Biological Evaluation of Medical devices" series standards，It generally includes, but is not limited to, cytotoxicity, sensitization, intradermal reaction, acute toxicity, subchronic toxicity, genotoxicity, and local reactions after implantation。

　　130.How to name arthroscopic passive surgical instruments？

　　A: The naming of arthroscopic passive surgical instruments should meet the requirements of relevant regulations, national standards and industry standards。Arthroscopic passive surgical instruments usually consist of 1 core word and no more than 3 characteristic words to determine the common name of the product, which can be named according to the object of action and intended use, such as knee arthroscopic surgical grasp, knee joint semi-circular file, arthroscopic bird's beak forceps, etc。Arthroscopic passive surgical instrument set products to reflect the product composition, functional use as the basic principle, composed of a variety of categories of instruments, generally should be named after its main intended use, such as hip endoscopic surgical instrument set。

　　131.How to divide the registration units of arthroscopic passive surgical instruments？

　　A: The division of registration units should be based on the requirements of relevant regulations and documents, and the division of medical device registration units is based on the technical principle, structural composition, performance indicators and application scope of the product。Different specifications and models of arthroscopic passive surgical instruments can be the same registration unit。Arthroscopic passive surgical instrument products provided in sterile and non-sterile form may be classified as the same registration unit。The division of registration unit of passive surgical instrument set under arthroscopy should first consider the intended use, and the surgical set with different intended use should not be regarded as the same unit。

　　132.How to divide the specifications and models of orthodontic wires？

　　Answer: Orthodontic wire can be divided into several types according to the preformed shape, the number of strands used in the parts, the cross-section shape, etc. : according to the preformed shape, it can be divided into straight wire and preformed bow wire，The preformed bow wire can be divided into different bows according to the characteristic size of the preformed shape (bow height, bow width, center radius, etc.);The parts used are usually divided into upper jaw and lower jaw;According to the number of components can be divided into single strand orthodontic wire and multi-strand orthodontic wire，Multiple orthodontic filaments consist of two or more monofilaments，Made by twisting, weaving or other processes;According to the section shape can be divided into round silk and square silk。Type II orthodontic wires can also be differentiated according to the temperature at which the austenitic transition ends。Orthodontic wire can be divided into different specifications according to the size of the cross-section。The size of the section can be expressed as the diameter of a single strand of round wire section, the inner diameter of a pipe that accommodates multiple strands of round wire, or the width, height, and diagonal of the square wire section。According to orthodontic wire practice, descriptors (that is, thousandths of an inch without the unit name) are usually used as identification codes。

　　133.What performance indicators should be included in the technical requirements of orthodontic wire products？

　　A: The performance indicators and inspection methods of orthodontic wire products can be referred to the corresponding industry standard YY/T 0625。If the performance indicators or test methods in the standard are modified, the content of the modification and the reasons should be explained, and verification materials should be submitted。Generally, the following performance indicators should be considered (but not limited to) : (1) appearance;(2) Size and tolerance requirements;(3) metal surface roughness;(4) Corrosion resistance;(5) austenitic transition end temperature (for type II orthodontic wire);(6) Mechanical properties;(7) the chemical composition of the material;(8) Harmful elements。If the registration applicant claims that the product has specific technical characteristics (such as microbial properties, coating properties, etc.), the corresponding performance indicators should be formulated。

　　134.For the second type of passive medical devices sterile after sterilization with ethylene oxide, what sterilization verification data should be provided when applying for the first registration？

　　A: Sterilization verification data should include sterilization plan and sterilization report, and the report should at least contain the main information of sterilization (such as sterilization batch number, production batch number) and sterilization results and sterilization conclusions。The sterilization results should be tabulated to describe the data summary information in the sterilization process (such as short-cycle, half-cycle and full-cycle experimental results)，Bacterial tablets, IPCD, EPCD and product test results);The sterilization conclusion should include sterilization parameters and loading diagram，The loading diagram should at least show the placement of the tablets and temperature sensors for sterilization verification。For the original records of sterilization verification, the sterilization batch record sheet for each cycle (including sterilization batch number, production batch number and the official seal of the sterilization enterprise) and the sterilization service agreement (including the product list) shall be submitted. Other original records shall be provided or not provided according to the completeness of the sterilization verification data。

　　135.When the second type of passive medical device is declared for the first registration, what requirements should be provided for the proof of raw materials？

　　A: In addition to denture products in accordance with the relevant document requirements to provide raw material registration certificate information, other products should provide raw material list。The material list can be the factory inspection report provided by the raw material supplier, the commissioned test report or the raw material test report issued by the testing institution entrusted by the registrant。

　　136.When the second type of passive medical device declaration is registered for the first time, what information should be described in the raw material part of the summary data provided by the registrant？

　　A: Information about raw materials，The registrant shall describe the composition of the material that comes into direct or indirect contact with the user and/or patient;Description of the material source, raw materials, intended purpose of use, main mode of action, material standards to be met, material certification materials provided by the supplier, etc.;The processing AIDS used in the whole processing process from raw materials to finished products, the role of processing AIDS, the quality control standards of processing AIDS, the removal of processing AIDS, and the residual form/residual amount/safety limit description of processing AIDS in the final product。

　　137.When the second type of passive medical device is declared for the first registration, which materials should be provided by the registrant for biocompatibility evaluation？

　　A: Biological evaluation should be performed on devices that come into direct or indirect contact with patients。Biological evaluation data should include:

　　(1) Describe the material used in the product and its contact with the human body，Contaminants and residues that may be introduced during design and production，Precipitates (including leaches and/or evaporates), degradation products, and process residues that may arise during design and production，Packaging materials and other relevant information in direct contact with medical devices;

　　(b) Describe the physical and/or chemical information of the declared product and consider material characterization, where applicable, where the physical action of the device may create biological risks and should be evaluated;

　　(3) Strategies, bases and methods for biological evaluation;

　　(4) Evaluation of existing data and results;

　　(5) Reasons and justifications for selecting or exempting biological tests;

　　(6) Other data necessary to complete the biological evaluation。

　　For the above materials, the registrant shall ensure that the following: The criteria on which the biological evaluation is based shall be correct;The evaluation project is complete;The existing data/results submitted should be traceable to the declared product and have supporting evidence。The biological report should contain detailed information on the test process that meets the appropriate criteria and establish a traceability relationship with the declared product;The original report should be submitted。

　　138.How to describe the product development process in the review data for the first registration of the second type of passive medical devices？

　　A: The registrant should explain the research and development background and purpose of the registered product。If there is a reference to similar products or previous generation products，Information on similar or previous products should be provided，And explain the reasons for choosing it as a reference for research and development;In addition to the above requirements，The registrant shall state the clinical problem solved by the declared product，The current means to solve the clinical problem, the advantages and disadvantages of different means, and the development trend，Market situation, main brands, differences, advantages and disadvantages of similar products with the same working principle/action mechanism of the declared products，Similar products or previous generation products for reference in the research and development of this declared product，The reason for choosing it as a reference for research and development。

　　139.How is the reference and comparison of the registered product with similar and/or previous generation products described in the review data at the time of the first registration of the Category II passive medical device declaration？

　　A: The registrant should explain the differences between the registered product and similar and/or previous products，The following can be compared and differentiated in a list:Product name, working principle/mechanism of action, specifications and models, structural composition, manufacturing materials, manufacturing process/use of processing AIDS, performance indicators, mode of action (such as implantation/intervention), scope of application, contraindications, precautions, form of provision (such as sterile provision/non-sterile provision/microbial limit control requirements), product validity period, product packaging, product use times (Such as single-use/reusable), etc。

　　140.How to select a typical type of custom fixed denture for testing？

　　Answer: According to the "Customized Denture registration Technical Review Guidelines"，Follow the "same registration unit，The products tested should be typical products that can represent the safety and effectiveness of all products in this registration unit.，A typical product is one or more products capable of covering all product processes within this registration unit。For example, the number of fixed dentures can be extracted not less than 3 units of metal baked porcelain bridge (casting, deposition, etc.), metal bridge (casting, deposition, etc.) and all-porcelain bridge (casting porcelain, CAD/CAM, etc.) for testing。If the enterprise only produces single crown products, one single crown can be extracted for testing。Bridges with a number of not less than 3 units may be covered with crowns, veneers, post cores and inlays of the same process。

　　141.When the second type of passive medical device is declared for the first registration, the manufacturing information should at least describe what information？

　　A: The manufacturing information in the first registration data should at least elaborate a brief description of the overall production process, production process flow chart, key process control description, special process control parameters, external process description (including supplier name and address), production inspection equipment list, production site introduction, research and development site introduction, site plan, etc。

　　142.When the second type of passive medical device is declared and registered, when there is a difference in the performance requirements of the general standard and the special standard cited, how should the performance indicators of the product technical requirements be formulated？

　　A: First of all, we should consider whether it is a mandatory standard, whether it is a general standard or a special standard, the mandatory standard is the highest level;If they are at the same level, that is, they are mandatory standards or recommended standards, and usually special standards take precedence over general standards。Under the above basic principles, it is recommended that registration applicants consider the performance requirements of the two standards in a comprehensive manner。

　　143.When the second type of passive medical device application is renewed, how should the application form write "Product overview" and "Main evaluation content of product safety and effectiveness"?？

　　A: The "Product Overview" suggests that: working principle or mechanism of action;Scope of application;Structure composition;Main materials, whether sterile supply, whether disposable use;Registration number and validity period。

　　In the "Main evaluation contents of product safety and effectiveness", it is recommended to state:

　　(1) The product has not changed during the renewal registration process;

　　(2) If the product is changed during the validity period of the medical device registration certificate, the change time and changes should be explained;

　　(3) If the new mandatory standards for medical devices are issued and implemented within the validity period of the medical device registration certificate, the changes made to comply with the new mandatory standards for medical devices should be explained;

　　(4) If there is an adjustment of the extended registration management category, it shall indicate the adjustment document of the management category, and indicate the management category before and after the adjustment;

　　(5) If the classification code of the renewed registration is adjusted, it shall indicate the classification code adjustment file, and explain the classification code before the adjustment and the classification code after the adjustment;

　　(6) If the original medical device registration certificate specifies the matters required to continue to complete, the completion of the matters should be explained;

　　(7) Summarize and state the safety and effectiveness of the extended registration product and whether it meets the requirements for extended registration。

　　144.The changes made by the continuation of registration products to comply with the new mandatory standards are not required to change registration procedures or changes, which declaration materials should be provided？

　　A: (1) The changes made by the registered product in order to comply with the new mandatory standards are not required to change the registration procedures or the explanation that no changes are required;

　　(2) If there is no need to change the registration procedures, the relevant supporting materials should be provided (at least including the copy of the original provisions of the old and new standards and the comparison table of the new and old standards and provisions).。

　　145.In the product technical requirements of the second type of in vitro diagnostic equipment, are environmental tests still required？

　　A: In accordance with the relevant spirit of the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, environmental testing may not be reflected in the product technical requirements。However, relevant research should still be reflected in the product development process, and submit relevant research data when registering。

　　146.What are the main components to be included in the specification？

　　A: It should include all the components involved in the reaction in the minimum sales unit (such as various reaction reagents, test cards) and auxiliary components in the inspection process (such as desiccant, colorimetric cards, sealing plate film, biosafety bag, dropper, calibration information code, etc.)。Without instruction。

　　147.What should I pay attention to when kit components are sold separately？

　　A: The sales package label should include the complete kit related information (such as product name, registrant, production address, etc.), and should indicate the basic information of the components (packaging specifications, storage conditions and expiration date, batch number, etc.) and matters to be noted。Original kit instructions should be attached to the package。If UDI coding is involved, it should comply with relevant regulatory requirements。

　　148.What is the accuracy requirement for semi-quantitative products？

　　A: Accuracy and detection limits can be combined, and should be verified for each segment point。The minimum requirements are: the difference between the test result and the labeled value of the corresponding reference solution is not more than one order of magnitude in the same direction, the reverse difference shall not occur, the positive reference solution shall not appear negative results, and the negative reference solution shall not appear positive results。Each level of detection should achieve 95% compliance rate。

　　149.In the technical requirements of the product, what are the specific requirements？

　　A: The specificity in the technical requirements of the product generally refers to cross-reaction, not interference。Therefore, in general, there is no such requirement for non-immunoturbidimetric biochemical reagents, and immune products should have such requirements if there are clear cross-reactants (such as different subtypes, etc.)。The concentration of added cross reactants should be selected at the clinically higher level。

　　150.Difference between bottles when required？

　　A: Dry powder reagents should generally have the requirements of inter-bottle difference and resolubility stability。

　　151.What are the requirements for multiple sample types in clinical evaluation？

　　A: If the declared reagent product is also applicable to serum, plasma and/or whole blood samples，Then the sample distribution should be: serum and plasma can be considered to belong to the same type for total statistics (but the consistency of the two needs to be verified by the preliminary analysis performance evaluation);If serum/plasma is present，And a whole blood sample，Homologous sample comparison should be carried out (the number of cases according to the requirements of regulations)，And the distribution of normal and abnormal values in whole blood requires the same serum/plasma。However, this situation is not applicable between blood, urine, cerebrospinal fluid and other samples, and clinical evaluation should be carried out separately。

　　152.In vitro diagnostic reagent packaging, label design style changes, manual layout and format adjustment, whether change registration is required？

　　A: No need。Other contents of the IVD specification that can be changed by themselves are referred to the Notice of the General Office of the General Administration of the State Administration of China on Issues related to the textual change of the specification of in vitro diagnostic Reagents (2016) No. 117).。

　　153.After some tumor markers are reduced from Class III to Class II, how to modify the description of "intended use" in the instruction manual？

　　A: After the swelling mark is reduced, the writing of "intended use" in the application form is consistent with that of conventional products。The first paragraph of the "intended use" in the specification should be consistent with the application form (same as the requirements of the second type of conventional products), and the second paragraph should be adjusted to the intended use of the classification document "clinically used in..."At the beginning, and add the expression "not for tumor screening in the general population.。The subsequent content of the second paragraph should be consistent with that of conventional products, and the relevant clinical significance should be described。

　　154.How is "intended use" described in the application form？

　　A: The kit should be clear "in vitro", "qualitative/quantitative", "sample type", "tested substance" and other information, calibration quality control products need to be clear about all items。Examples are as follows:

　　Example 1: Used for in vitro qualitative detection of the activity of ××× in human serum and plasma。

　　Example 2: In vitro quantitative determination of human serum ××× content。

　　Example 3: Used with our kit for calibration of ×× test system。

　　Example 4: Used with our kit for A, B, C......Indoor quality control of total x items。

　　155.For the hypersensitive C-reactive protein kit, whether the tested substance in its intended use is "hypersensitive C-reactive protein"？

　　A: This understanding is wrong。The tested substance is still "C-reactive protein", and "hypersensitivity" is only an expression of the high sensitivity of this type of product。Therefore, it should be expressed as "for the quantitative detection of C-reactive protein content in human serum and plasma in vitro".。

　　156.What factors should be considered if the product is declared quantitatively or qualitatively？

　　A: First of all, we should consider the clinical practical application needs and whether there are similar products on the market, and then the sample type should also be considered, generally for stool, saliva, throat swabs and other heterogeneous samples it is difficult to achieve a "quantitative" test in a real sense。

　　157.What factors should be considered if the product wants to be declared for home or patient self-testing？

　　A: First of all, we should consider whether the product has home or patient self-testing needs and application value, and then we should consider the convenience of obtaining samples, which are generally urine, saliva, fingertip blood, etc。For specific requirements, please refer to the Guiding Principles for the Technical Review of Household in Vitro Diagnostic Medical Device Registration.。

　　158.What is the requirement of the English name of the product in the manual？

　　A: It is not recommended to write an English name, if necessary, the English name should be correct and complete, and only abbreviations are not allowed。Literal translation, not free translation。

　　159.What are the requirements for the Chinese legal part of the product name？

　　A: Biochemical kits can refer to YY/T1227-2014 "Naming of Clinical Chemistry in vitro Diagnostic Reagents (boxes)", do not recommend the use of methodology: endpoint method, rate method, continuous monitoring method, IFCC method, etc。Colloidal gold method should be "colloidal gold immunochromatography", chemiluminescence method should be "chemiluminescence immunoassay" or "magnetic particle chemiluminescence immunoassay".。

　　160.How to express the product packaging specifications？

　　A: Different packaging specifications should be differentiated according to the separation level using a stop, comma, semicolon, unified end。If there is only a single package size, it can be followed without punctuation。Examples are as follows:

　　Example 1:48 persons/box

　　Example 2:48 test/box, 96 test/box。

　　例 3： 试剂 1(R1)：5mL×5， 试剂 2(R2)：5mL×5； 试剂 1(R1)：10mL×10，试剂 2(R2)：10mL×10。

　　Example 4: Reaction solution: 15mL×1, buffer solution: 45mL×1, calibrator: 2mL×1。

　　Example 5: ××× type: 4mL×10(freeze-dried product, resolution volume)

　　161.Product technical requirements, how to linear requirements？

　　Answer: The expression of attention interval: [A, B]mg/L, (A%, B%);The linear lower limit should not be zero in principle, and the upper limit should meet the actual clinical needs。The linear deviation can be segmented to give the absolute deviation and relative deviation requirements。When setting the boundary point between absolute deviation and relative deviation, the medical determination level concentration should be placed within the required range of relative deviation in principle.And the absolute and relative deviation requirements should take into account the continuity of the demarcation point。

　　For example, the medical decision level is 20mg/L, the deviation requirement is 15mg/L, and the absolute deviation requirement is ≤1.5mg/L, the relative deviation is less than 10%。

　　Immunological products generally only require a linear interval to be given, and may not require linear deviation。

　　162.In the product technical requirements, what is the detection limit/blank limit requirement？

　　A: Immunological products generally have this requirement。Can choose one of the two, if there is no corresponding national standards or guidelines, it is recommended to give the detection limit requirements。

　　163.In the technical requirements of the product, what is the accuracy requirement？

　　A: If there is no corresponding national bank standard or guiding principle, in principle, one of three ways is used: relative deviation (reference material or reference method value), recovery test (pure product added to human samples), comparison test (similar products already on the market).。For products with applicable national standards, the relative deviation method should be adopted。

　　164.What are the requirements for repeatability in product technical requirements？

　　A: If there is no corresponding national standard or guiding principle, 2 to 3 samples of different concentration levels can be selected within the linear range。When choosing concentrations, linear width and medically determined levels should be considered, normal and outlier levels can be selected (weakly positive recommended)。

　　165.How to write "Product Overview" and "Main evaluation Content of product safety and effectiveness" when applying for extension registration of in vitro diagnostic reagents?？

　　A: In the "Product Overview" it is recommended to state: the intended use of the product;The main components;Detection principle;Registration number and validity period。

　　In the "Main evaluation contents of product safety and effectiveness", it is recommended to state:

　　(1) The product has not changed during the renewal registration process。

　　(2) If the product changes during the validity period of the registration certificate, the number of changes, the time of change and the changes shall be clearly defined。

　　(3) If there are new mandatory medical device standards and/or national standards issued and implemented within the validity period of this medical device registration certificate, changes made to comply with the new mandatory medical device standards and/or national standards。

　　(4) If the continuation of registration is a product with an adjustment of the registration management class, the management class adjustment document shall be indicated, and the management class before and after the adjustment shall be clearly defined。

　　(5) If the continuation of registration is a product with adjusted classification code, the classification code adjustment file shall be indicated, and the classification code before adjustment and the classification code after adjustment shall be clearly defined。

　　(6) If the original medical device registration certificate contains matters requiring continued completion, the completion of matters should be explained。

　　(7) Summarize and state the safety and effectiveness of this extended registration product and meet the requirements for extended registration。

　　166.At present, the chemical luminescence method, colloidal gold method, fluorescence method and other closed system reagents increase with the original registration certificate specification of the applicable instrument manufacturers of different models, can in accordance with the "Beijing medical device rapid review and approval Measures" 13th declaration for rapid review and approval？

　　A: Considering the applicability of closed system instruments and the need to fully verify the safety and effectiveness of reagents on new instruments, it is recommended that registrants add applicable instruments in accordance with the normal "change registration" process and materials to declare。

　　167.Continuation of registration in vitro diagnostic reagent products to comply with the new national standards issued by the implementation of changes do not need to change the registration procedures or do not need to change, which declaration materials should be provided？

　　A: (1) The changes made by registered products in order to comply with the release and implementation of new national standards belong to the explanation that there is no need to change the registration procedures or changes;

　　(2) If there is no need to change the registration procedures, the relevant supporting materials should be provided (at least including the copy of the old and new national standard specifications and the comparison table of the provisions involved in the old and new national standard specifications).。

　　168.In line with the requirements of Article 13 of the Beijing Medical Device Rapid Review and Approval Measures, which declaration materials should be prepared for the products for rapid review and approval？

　　答：

　　169.In accordance with the "Beijing Medical Device rapid review and approval Measures" Article 13 of the application for rapid review and approval, adding applicable instruments, what are the requirements for the added applicable instruments？

　　A: (1) The new applicable instrument shall have the same degree of automation as the applicable instrument in the original product manual。

　　(2) The new applicable instrument shall be the same as the applicable instrument in the original product manual。

　　(3) The new applicable instrument shall be a domestic listed medical device, that is, a medical device registration certificate has been obtained。

　　Only if the above three conditions are met at the same time can they be declared in accordance with Article 13 of the Beijing Medical Device Rapid Review and Approval Measures。

　　170.For in vitro diagnostic reagent products that have been downgraded from Class III to Class II, can the relevant contents on main raw materials, production processes and semi-finished products requirements in the appendix of Product Technical Requirements be deleted during the continued registration process？

　　A: According to the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, for the third type of in-vitro diagnostic reagent products, the main raw materials and production process requirements should be clearly defined in the form of an appendix in the product technical requirements。There is no such requirement for the second type of in vitro diagnostic reagents。

　　171. Medical device registration quality management system verification declaration data include？What are the requirements?？

　　A: The workflow and application data requirements for the verification of the quality management system for the second type of medical device registration can be found on the website of Beijing Municipal Drug Administration (http://yjj).beijing.gov.cn/) for more information。

　　Specific documents include:

　　(1) Overview The applicant for registration shall undertake to establish a corresponding quality management system in accordance with relevant regulations and accept the quality management system verification at any time。

　　(2) The chapter table of contents shall include all the headings and subheadings of the chapter, indicating the page numbers of the contents in the table of contents。

　　(3) Manufacturing information

　　A.Product Description information A brief description of how the device works and the overall production process。

　　B.General Manufacturing information Provides all addresses and contact information for manufacturing devices or their components。If applicable, the names and addresses of all important suppliers of outsourced production, production of important components or raw materials (e.g. animal tissues and pharmaceuticals), critical processes, sterilization, etc., should be provided。

　　(4) Quality Management System procedures The high-level quality management system procedures used to establish and maintain the quality management system, including quality manuals, quality policies, quality objectives and documentation and record control procedures。

　　(5) Management responsibility procedures Procedures for establishing and maintaining a quality management system through the elaboration of quality policy, planning, responsibilities/authority/communication and management review。

　　(6) Resource Management procedures Procedures for documentation of sufficient resources (including human resources, infrastructure and work environment) for the implementation and maintenance of the quality management system。

　　(7) Product realization procedures High-level product realization procedures, such as procedures that describe planning and customer-related processes。

　　A.Design and development procedures A procedure for forming a systematic and controlled development process documentation of product design throughout the entire process from project inception to design transformation。

　　B.Procurement Procedures Procedures used to form documents for the procurement of products/services that comply with established quality and/or product technical parameters。

　　C.Production and service control procedures Procedures used to document production and service activities under controlled conditions that address issues such as product cleaning and contamination control, installation and service activities, process validation, marking and traceability。

　　D.Monitoring and measurement equipment control procedures Procedures to establish that the monitoring and measurement equipment used in the operation of the quality management system has been controlled and continuously conforms to the established requirements。

　　(8) Procedures for measurement, analysis and improvement of the quality management system Procedures for establishing documented procedures for monitoring, measuring, analysis and improvement to ensure conformity of products and the quality management system and to maintain the effectiveness of the quality management system。

　　(9) Other quality system procedure information does not belong to the above content, but is more important to the declaration of other information。

　　(10) Quality management system verification documents According to the above quality management system procedures, the registration applicant shall form relevant quality management system documents and records。The following information shall be submitted for inspection during the quality management system verification。

　　A.Basic information sheet of applicants for registration。

　　B.Organization chart of the applicant for registration。

　　C.Production enterprise general layout, production area distribution map。

　　D.If the production process has purification requirements, a copy of the environmental testing report issued by a qualified testing agency (with a plane layout) shall be provided。

　　E.The production process flow chart of the product shall indicate the main control points and projects, the sources of the main raw materials and purchased parts and the quality control methods。

　　F.Main production equipment and inspection equipment (including the relevant equipment required for incoming inspection, process inspection and final inspection;For those produced under purified conditions, environmental monitoring equipment shall also be provided。

　　G.Quality management system self-inspection report。

　　H.If applicable, a comparison between the product to be verified and the product that has been verified in the past in terms of production conditions, production processes, etc., shall be provided。

　　The third type of medical device registration and application requirements can be seen in the online service hall of the National Drug Administration (Online service Hall of the National Drug Administration search)http://zwfw.nmpa.gov.cn/web/tasklist/corporate?theme=YLQX。

　　172.Medical device production quality management standards on-site inspection time and inspectors have what requirements？

　　A: (a) The on-site inspection time is generally 1 to 3 days;

　　(2) The on-site inspection shall implement the inspection team leader responsibility system, and the inspection team shall be composed of more than 2 (including 2) inspectors。

　　(3) When necessary, the Beijing Municipal Drug Administration may invite relevant experts to participate or entrust a third-party institution to carry out on-site inspection。

　　173.How to carry out authenticity verification of products for testing and clinical trials for registration？

　　A: The authenticity verification of inspection products and clinical trial products for registration is carried out at the same time as the verification of the medical device registration quality management system，Focus on records related to design and development process implementation planning and control, procurement records for sample production, production records, inspection records and sample retention and observation records (if applicable)。

　　174.Whether the medical device product registration change will carry out the medical device registration quality management system verification？

　　A: According to the provisions of the Medical Device Registration Administration Measures (State Administration for Market Supervision and Administration Order No. 47) and the in Vitro Diagnostic reagent Registration Administration Measures (State Administration for Market Supervision and Administration Order No. 48)，During the technical review of the change registration application，It is considered necessary to check the quality management system，The device review center shall organize the quality management system verification。

　　175.What obligations and responsibilities should the registrant who entrusts other enterprises to produce medical devices bear？

　　答：1.In accordance with the law, medical device design and development, clinical trials, manufacturing, sales and distribution, after-sales service, product recall, adverse event reporting and other relevant legal responsibilities。

　　2.Sign the entrustment contract and quality agreement with the entrusted production enterprise, clarify the technical requirements, quality assurance, responsibility division, release requirements and other responsibilities in the commissioned production, and clarify the production release requirements and product release methods。

　　3.Strengthen the supervision and management of the entrusted production enterprises, evaluate the quality management ability of the entrusted production enterprises, and regularly evaluate and audit the quality management system of the entrusted production enterprises。

　　4.Strengthen the monitoring of adverse events, establish the corresponding traceability management system for medical devices according to the risk level, and ensure that medical device products can meet the requirements of full traceability。

　　5.It can sell medical devices by itself, or it can entrust medical device management enterprises with relevant qualifications to sell。The registrant who sells the medical device by himself shall have the prescribed capacity and conditions for operating the medical device;Where sales are commissioned, an entrustment contract shall be signed to specify the rights and obligations of each party。

　　6.Through information means, the whole process of research and development, production, sales and adverse event monitoring is traced and monitored。

　　7.Ensure that the submitted research data and clinical trial data are reliable, systematic and traceable。

　　176.What are the minimum professional personnel that a registrant who entrusts a manufacturer to produce medical devices should have, and what are the requirements to be met？

　　A: (1) There should be a management representative。The management representative is appointed by the legal representative or the principal responsible person to fulfill the responsibilities of establishing, implementing and maintaining the effective operation of the quality management system。

　　(2) It shall be equipped with specialized R & D technical personnel, familiar with the R & D and technology of the registered medical device products, with corresponding professional background and work experience, to ensure that the submitted research data and clinical trial data are true, complete and traceable。

　　(3) Special quality management personnel should be equipped with work experience, familiar with the production quality management requirements of the registered medical device products, and able to evaluate, audit and supervise the quality management system of the medical device registrant and the entrusted production enterprise。

　　(4) Special regulatory affairs personnel should be equipped with work experience, familiar with the regulatory requirements of registered medical device products, and able to handle relevant regulatory affairs。

　　(5) Special post-market affairs personnel should be equipped with work experience, familiar with medical device adverse event monitoring, product recall, after-sales service and other requirements, and able to handle relevant post-market affairs。

　　177.Whether the products involved in the List of Prohibited Production of Medical Devices by the State Drug Administration can be commissioned by the registrant to carry out production activities？

　　A: For the products in the List of Prohibited Production of Medical Devices by the State Drug Administration, the registrant shall not carry out production activities by entrusting the production enterprise。

　　178.How to prepare the Medical Device Commissioned Production Quality Agreement？

　　A: Commissioned production refers to the medical device registrant and record holder (hereinafter referred to as the "entrusting party") entrusts other production enterprises (hereinafter referred to as the "entrusted party") to carry out production activities。

　　Through the signing of "Medical Device entrusted Production Quality Agreement"，Specify when medical devices are commissioned for production，The respective rights, obligations and responsibilities of both parties in the whole process of product production;Standardize the obligations and responsibilities of both parties for product quality and safety of commissioned medical devices;Ensure that the commissioned medical devices comply with the relevant requirements of registration/filing and production license/filing，Effectively ensure the safety, effectiveness and quality control of listed medical devices，To ensure human health and life safety。

　　For details, please refer to the "Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices" issued by the State Drug Administration.。

　　179.Whether the registration applicant can entrust other institutions to carry out medical device research and development？

　　A: Yes。The registration applicant shall clarify the scope and extent of the R&D activities entrusted by the product R&D activities and the requirements for the R&D capabilities and continuous technical support capabilities of the entrusted R&D institutions, and evaluate the R&D capabilities and continuous technical support capabilities of the entrusted parties to ensure that they meet the requirements。

　　180.When the entrusted production enterprise produces the entrusted products, how to control the quality management system of its own products and entrusted products？

　　A: When the entrusted production enterprise has the same product in production, it should have a significantly different number, batch number and process identification management method from the entrusted production product to avoid confusion。

　　181.How should the medical device registrant carry out commissioned production and how to release the product？

　　Answer: The medical device registrant and record holder commissioned the production，The quality assurance capability and risk management capability of the agent shall be evaluated，In accordance with the requirements of the commissioned production quality agreement guidelines formulated by the State Food and Drug Administration，Sign quality agreement and entrustment agreement with them，To supervise the performance by the agent of its obligations under relevant agreements;The entrusted manufacturing enterprise shall organize production in accordance with laws, regulations, rules, medical device production quality management norms, mandatory standards, product technical requirements, entrusted production quality agreements and other requirements，Responsible for production activities，And accept the supervision of the medical device registrant and record holder。

　　The entrusted production enterprise shall report to the original production license or production record department the variety of products increased production，And provide the entrusting party, entrusted products, entrusted period and other information;Increasing production of goods involves changes in production conditions，May affect product safety and effectiveness，A report shall be made to the original production licensing department 30 working days prior to the addition of the product，The original production licensing department shall carry out on-site verification in a timely manner。Where there is a change in the licensing matters, the relevant licensing changes shall be handled in accordance with the provisions。

　　The medical device registrant and filing person shall be responsible for the release of the product on the market, establish the release procedures for the product on the market, clarify the release standards and conditions, and review the production process records and quality inspection results of the medical device. If the standards and conditions are met, the authorized release personnel can sign the listing。Where production is commissioned, the medical device registrant and recordholder shall also review the production release documents of the commissioned production enterprise。The entrusted production enterprise shall establish production release procedures, specify the standards and conditions for production release, and confirm that the standards and conditions are met before leaving the factory。Any product that fails to comply with laws, regulations, rules, mandatory standards and technical requirements registered or filed may not be released from the factory or put on the market。The registrant or recordholder of a medical device shall not entrust the manufacturer to release the device for listing。

　　182.What forms are included in the release of medical devices？

　　A: The release of medical devices includes production release and market release。

　　183.How should medical device registrants, recordholders, and entrusted manufacturers implement the reporting system？

　　A: In order to further implement the main responsibilities of medical device registrants, recordholders and entrusted production enterprises, the "Measures for the Supervision and Administration of Medical Device Production" establishes a medical device reporting system and stipulates corresponding legal responsibilities。Medical device registrants, recordholders and commissioned manufacturers shall implement the medical device reporting system in accordance with regulations。

　　First, we will implement the self-inspection and reporting system。Medical device registrants, recordholders, and entrusted manufacturers shall conduct self-inspection of the operation of the quality management system every year, prepare self-inspection reports in accordance with the requirements of the guidelines for the preparation of the annual self-inspection report of the medical device production quality management system, and submit self-inspection reports to the local drug regulatory authorities before March 31 of the next year。The registrant or recordholder of imported medical devices shall submit a self-inspection report by his agent to the drug regulatory department of the province, autonomous region or municipality directly under the Central government where the agent is located。

　　Second, we will implement a reporting system for product varieties。A medical device manufacturer shall report to the drug regulatory department the variety of the products it produces。Where the variety of products to be produced is increased, a report shall be made to the original production license or production filing department, and where entrusted production is involved, information such as the entrusting party, entrusted products and entrusted period shall also be provided。If a medical device manufacturer increases the production of products involving changes in production conditions that may affect product safety and effectiveness, it shall report to the original production licensing department 30 working days before increasing the production of products, and the original production licensing department shall carry out on-site verification in a timely manner。Where there is a change in the licensing matters, the relevant licensing changes shall be handled in accordance with the provisions。

　　Third, we will implement a system for reporting changes in production conditions。Where the production conditions of the medical device registrant, recordholder or entrusted manufacturer change and no longer meet the requirements of the medical device quality management system, corrective measures shall be taken immediately;If it may affect the safety and effectiveness of medical devices, it shall immediately stop production activities and report to the original production license or production filing department。The entrusted manufacturer shall promptly inform the medical device registrant and recordholder of the changes。

　　Fourth, we will implement a reporting system for restarting production。If a medical device manufacturer stops production for more than one year continuously and has no similar products in production, it shall carry out necessary verification and confirmation when restarting production, and report to the drug regulatory department in writing。If the quality and safety may be affected, the drug regulatory department may organize verification as needed。

　　184.What are the specific requirements for medical device registration applicants to establish quality management system documents？

　　A: The applicant shall establish the quality management system documents suitable for the application of registered products, including quality manuals, procedure documents, technical documents and data records。Technical documents shall include product technical requirements and related standards, production process rules, operation instructions, inspection and test operation rules and other relevant documents。Data and records shall ensure traceability of activities such as product design and development, material procurement, production, quality control and product release。

　　185.What do you need to pay attention to in the use of biosafety cabinets？？

　　A: After the installation of the biosafety cabinet is completed, the installation inspection needs to be carried out after the position is moved。Maintenance inspections should be carried out at least once a year, as well as when the biosafety cabinet has been replaced with filters and internal components repaired。For specific inspection requirements and inspection items, see Biosafety Cabinet (YY0569).。

　　186.Whether sterile and implantable medical device manufacturers can perform parametric release of products？

　　A: For aseptic and implantable medical device manufacturers with their own product sterilization capabilities，Its factory inspection items stipulate the sterility inspection of products，Can be implemented in accordance with the provisions;If required to detect biological indicators (tablets)，On the basis of scientific verification of the sterilization process，The product can be released by testing the bacteria tablets。

　　187.Do medical devices provided in a non-sterile state need to be organized for production in a clean environment？

　　A: For implanting medical devices provided in a non-sterile state, the production environment of the last cleaning and packaging process should refer to the "Standard for the Production Management of Sterile Medical Devices" (YY0033-2000) standard or self-verify and determine the production environment to effectively control the initial contamination bacteria。

　　188.The applicant for medical device registration entrustsqualified medical device inspection institutions for the whole project, whether the requirements of the Guiding Principles for On-site Inspection of Beijing Medical Device Registration Self-Inspection Quality Management System (Trial) are applicable？

　　A: Not applicable。

　　189.In the process of medical device registration verification, whether the registration applicant is required to arrange dynamic production？

　　A: During the on-site inspection, the relevant personnel of the registration applicant should be familiar with and able to complete the relevant operations of the product, and the relevant equipment should be able to operate normally to prove that the registration applicant has the production capacity of the declared product。For the registration verification carried out when declaring the registration of sterile and implantable medical devices, dynamic production should be carried out。

　　190.What are the results of the on-site inspection of the medical device registration quality management system verification？If any rectification is needed, how long is the rectification period？

　　A: In the verification of the medical device registration quality management system, the inspection team's recommendations on the on-site inspection are divided into three situations: "passed the inspection", "review after rectification" and "failed to pass the inspection"。If the recommended conclusion is "passed the inspection" or "failed to pass the inspection", the Municipal device review Center will review the inspection data submitted by the inspection team within 5 working days after the on-site inspection is completed and put forward the review conclusion。The recommended conclusion is "review after rectification"，Registration applicant within 1 month after the completion of the on-site inspection，Submit rectification report and review application to the municipal Device Review center at one time，The municipal device review center has received recommendations and inspection data from the inspection team，And the rectification report submitted by the registered applicant and the review application，Audit within 5 working days，Present a conclusion。If the conclusion of the review is still "review after rectification", the Municipal device review center shall inform the registration applicant of the contents of the rectification within 3 working days from the date of the review conclusion。The registration applicant shall submit a rectification report and review application to the Municipal Device Review Center within 5 months from the date of receiving the rectification opinions。The municipal device review center shall complete the review within 30 working days after receiving the rectification report and review application。Those that can be verified through data may be exempted from on-site review。If the rectification passes the verification, the review conclusion is "the rectification passes the verification".。If the review application and rectification report are not submitted within the prescribed time limit, or the requirements of "passing the verification" are still not met after the rectification review, the review conclusion is "failing to pass the verification after rectification".。If the registration applicant refuses to accept the system verification, the examination conclusion is "not passed the verification".。

　　191. At present, what are the classification and definition documents of in vitro diagnostic reagents that can be referred to？

　　A: As of July 31, 2022, the classification and definition documents for in vitro diagnostic reagents can be referred to as follows:

　　(1) Classification Rules for in Vitro Diagnostic Reagents

　　(2) 6840 In Vitro Diagnostic Reagents Classification Subdirectory (2013 edition)

　　(3) The annex of the Circular of the General Administration of Allergens, flow cytometry supporting, immunohistochemical and in situ hybridization in vitro diagnostic reagents Product attribute and category adjustment (2017 No. 226), "In vitro Diagnostic reagents Product Classification List for Flow cytometry Supporting", "In vitro diagnostic reagents Product Classification List for immunohistochemical and in situ hybridization", "not managed as medical devicesProduct List

　　(4) Announcement of the State Food and Drug Administration on adjusting part of the "6840 in Vitro Diagnostic Reagent Classification Subcatalog (2013 edition)" (No. 112 of 2020)

　　(5) Summary of results of classification and definition of medical device products for 7 times since 2018

　　192.Whether the newly developed medical devices that are not included in the "Classification of Medical Devices" must be classified and defined before they can be registered or filed？

　　答：否。According to the provisions of Article 23 of the Regulations on the Supervision and Administration of Medical Devices, newly developed medical devices that have not yet been listed in the classified catalogue，The applicant may directly apply for product registration in accordance with the provisions of this Regulation on the registration of Class III medical device products，It may also determine the product category according to the classification rules and apply to the drug regulatory department under The State Council for category confirmation, and then apply for product registration or product filing in accordance with the provisions of these Regulations。

　　193.What work does the applicant need to complete before declaring the classification of medical devices？

　　A: First, the product design and development work has been basically completed, the product has been finalized, there are prototypes or products, and the relevant work of applying for product registration or filing is planned。

　　The second is to define the attributes, according to the definition of medical devices, determine whether the product is a medical device, if it is determined to be a medical device for follow-up matters。

　　The third is to consult the relevant classification definition documents, through the comprehensive judgment of product name, intended use, structural composition, use method and other aspects, to confirm that the product to be applied for classification definition is not in all the classification definition documents that have been disclosed。

　　The fourth is to find whether there are similar or similar products that have been listed at home and abroad。

　　The fifth is to prepare relevant technical documents in accordance with the "Beijing Medical Device Classification and Definition Declaration Requirements"。

　　194.To apply for the classification of medical devices, the applicant needs to complete what declaration work？

　　A: The first step: The applicant passes the home page → Office hall → Medical Device Standards and Classification Management → Medical Device Classification and Definition Information System of China National Institute of Food and Drug Control (http://app).nifdc.org.cn/biaogzx) to register online, after registration, fill in the "Classification definition Application form", and upload other application materials。

　　Step 2: The applicant should print the online "Classification definition Application Form", together with other application materials stamped with the applicant's seal, and submit the application materials to the Beijing Medical Device Review and Inspection Center by mail or on-site。(Address: No. 13 Shuiche Hutong, Xicheng District, Beijing, Tel: 010-58549949)。

　　The paper application materials shall comply with the Declaration Requirements for the Classification and Definition of Medical Devices in Beijing, and ensure the consistency of the paper application materials and the information filled in online。

　　195.What should be noted when filling in the online application？

　　A: (1) The content of the Medical Device Product Classification Registration Form is complete and accurate, and the items that are not applicable should be marked "none" or "not applicable"。

　　(2) The "principle of action or mechanism" item in the "Medical Device Product Classification Definition Registration Form" should be filled in clearly, such as liquid dressing products, should list each ingredient and the role of the ingredient, otherwise it can not determine its attribute or category。

　　(3) If you have to fill in the "domestic and foreign similar products" item in the "Medical device product classification definition Registration Form", it should indicate the similarities and differences between the products to be declared and similar products at home and abroad, and explain the classification of similar products。

　　(4) The "enterprise opinion" item in the "Medical device product classification definition Registration Form" must be filled in to clarify the enterprise proposition and define the category, and write the reason for the enterprise proposition, which can refer to the relevant documents for classification definition, and can also refer to the situation of similar products that have been listed。

　　(5) The attachments uploaded online should be complete, and the products advocating innovation should upload materials related to new products。

　　196.What should be noted when preparing paper version materials？

　　A: (1) The legal representative of the "Medical device Product Classification Registration Form" shall sign, fill in the declaration date and affix the official seal。

　　(2) An enterprise with a business license shall provide a copy of the business license to confirm the company's legal representative。

　　(3) The paper version of the material should be stamped with the official seal, non-single page materials should also be stamped with the seal。

　　(4) If the contact person in the Medical Device Product Classification Definition Registration Form is not the legal representative, the Power of attorney shall be submitted.。

　　197.What is the specific operation difference between domestic products and imported and Hong Kong, Macao and Taiwan products when applying for the classification of medical devices？

　　A: The relevant materials of domestic products shall be submitted to the provincial drug supervision and administration department where the applying enterprise is located, and the relevant materials of imported and Hong Kong, Macao and Taiwan products shall be submitted to the Medical Device Standard Management Center of the State Drug Administration。

　　198.What requirements should be met by the product technical requirements and product specifications submitted when applying for classification definition？

　　A: The technical requirements of the product shall comply with the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products;Medical device product specifications shall comply with the Medical Device Specifications and Label Management Regulations，Instructions for in vitro diagnostic reagents shall comply with the Regulations on the Management of Medical Device Instructions and Labels and the Guiding Principles for the Preparation of Instructions for in Vitro Diagnostic Reagents.。

　　199.The Power of Attorney and Self-Assurance Statement need to be submitted in the paper version of the materials. Do you have a template for the relevant materials？

　　A: There is a template, the specific download address is: http://yjj.beijing.gov.cn/yjj/zwhd/bgxz/ylqx/index.html。

　　200.At present, what are the medical device classification and definition documents that can be referred to？

　　A: As of July 31, 2022, the medical device classification documents that can be referred to are as follows: