1. The Work on Medical Device Registration
(a) The gradual improvement of medical device registration management regulatory system
The issue of the ” Quality Management Practices of Medical Device Clinical Trial”, ” Naming Rules of Generic Terms of Medical Device “, ” Priority Approval Procedures of Medical Device “, “Directory of Class Ⅱ medical devices free of clinical trials (the second batch)” and ” Directory of class Ⅲ medical devices free of clinical trials (the second batch) “.
(b) Continued deepening of review and approval system reform of medical devices
In 2016, China Food and Drug Administration established a medical device review and approval system reform office, developed the reform task decomposition table of the year 2016, supervised and instructed the reform work, and promoted the reform task in an orderly manner.
- Medical Device Technical Review Center of China Food and Drug Administration established and completed the quality management review system and rules documents.
- The center promoted the classification management reform, completed the “Classification Directory of Medical Device (Draft)”, established professional groups of the Medical Device Classification Technical Committee according to the reform requirements of review and approval.
- Actively promoted the development of the medical device standards, determined 106 medical device industry standard programs, approved and issued 250 medical device industry standards of surgical implants, disinfection devices, including 48 mandatory standards, 202 recommended standards, and issued a revision of standard.
- Issued the second batch of directory of class Ⅱ medical device free of clinical trial, exempted clinical trials of 267 kinds of class Ⅱ medical devices, 92 kinds of class Ⅲ medical devices, a total of 359 medical device products, including 15 kinds of in vitro diagnostic reagents product, which were also the first time for the in vitro diagnostic reagent products to be listed on the directory of free of clinical trials.
- The intensity of spot check to the authenticity of clinical trials was increasing.
- Completed the “On the adjustment of some parts of medical device administrative review and approval procedures” (Exposure draft), and asked for public comments.
(c) Enhanced the supervision and management of medical device registration
Developed, modified and issued 52 technical review guidelines of medical device registration in 2016. This included 30 developed and 22 revised ones. Issued the “Technical Guidelines of Medical Device Network Security “for the current development situation of medical devices. The Center also deployed 33 technical review guidelines writing items of medical device registration.
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