2022 is the first year for the Beijing Medical Device Evaluation and Inspection Center to fully perform its functions after the reform of the organization. The center takes the "construction of the Capital characteristic medical device evaluation and inspection Center" as the starting point, clarifies the ideas, works earnestly, and serves the high-quality development of the capital medical device industry。

       First, political guidance, take the initiative to plan the new pattern of review and inspection

       First, the quasi-political orientation。Put politics in the first place, from the height of political positioning and promote the review and inspection work。Second, build "four beams and eight columns"。Plan and layout from the aspects of regulations and standards, normative guidelines, quality system, service development and team construction, establish personal assessment and department performance assessment management systems, and effectively guarantee the authority of review and inspection work with ability and integrity。Third, we will strengthen planning guidance。Formulate and implement the implementation measures of the drug safety and high-quality development plan during the "14th Five-Year Plan" period, and provide compliance for the center to take the initiative to act as a service industry development。

       Second, take multiple measures to effectively build a new path for improving the effectiveness of review

       First, improve institutions and mechanisms。We will improve rules of procedure, rules for review and correction, and systems for verification procedures, establish mechanisms for supervision, supervision, restriction and supervision, assessment and evaluation, and education and training, revise quality management system documents, and build a practical and effective work system。Second, strengthen the management of the review process。Follow the principle of risk management, comprehensively apply the combination of scientific sub-examination, standardized correction, hierarchical review and broadening consultation channels, and use process data to track and promote the review progress。Third, we will improve the effectiveness of verification。Under the new legal system, the registration verification procedures, verification guidelines, and optimization inspection guidelines have been written, and the optimization of the verification process has been promoted as a whole, so that all links are connected in a more orderly manner。

       In 2022, 3,334 Category II medical device registration reviews were completed, and the average time for the first registration review was reduced from the statutory 120 working days to 64 working days;Completed 784 registration checks, an increase of 58% year-on-year。There are 63 registration verification failed to pass, the failure rate is 8%, establishing the inspection authority, forcing enterprises to implement the main responsibility。

       Third, service innovation, and strive to inject new momentum into industrial development

       First, the service channel has been comprehensively expanded。With the "drug administration policy into the park" as the carrier, through "early intervention" and "forward focus" to rescue enterprises。Set up a team of excellent lecturers to carry out graded and classified lectures, compile and issue 300 questions of review consultation, establish review "standard library", "toolbox" and personalized "service package", and effectively improve the quality of enterprise declaration materials。Second, the pace of services was accelerated。Track and manage 93 enterprises with innovation ability in the city, and focus on solving the difficulties encountered in the research and development and production links。Organize the formulation of 3D printing custom denture registration review guidelines and inspection guidelines to fill the gaps in industry regulatory documents。Benefiting from all kinds of guidance and services of the Center, some enterprises such as 3D printing dentures, antigen detection reagents, and AI-assisted recognition software have entered the "fast lane" of development.。

       "The effort of the accumulation of strength is invincible;In 2023, the center will work hard to open a new bureau 踔厉, gather strength and start again, focus on "promoting the rapid launch of products", unite and strive to be a pioneer, and strive to promote the capital medical device evaluation and inspection work to a new level!

Contributed by | Beijing Medical Device Evaluation and Inspection Center

(Source: Beijing Drug Administration)