Everything has a rule to follow. The rule is not only the specification and law, but also standard and scale. On April 20, 2017, Center for Medical Device Evaluation, China Food and Drug Administration (CMDE) released Medical Device Technical Review Quality Management Standards (for Trial) (hereinafter referred to as Management Standards). In fact, the Management Standards has been printed and implemented inside the CMDE on January 6, 2017.

“Releasing the Management Standards is mainly intended for allowing the medical device enterprises understand the review system reform and supervise our review.” said Kong Fanpu, director of CMDE. The launch of Management Standards completed our medical device technical review quality management system and strengthened the risk control to the technical review, and therefore improved the quality and efficiency of medical device technical review.

One objective: complete review quality management system.

On August 25, 2015, the State Council issued the Opinion of State Council on Reformation of Examination and Approval system for Drug Medical Devices (GF[2015] No. 44), making a clear requirement to improve the examination and approval quality, and establishing more scientific and effective drug medical device examination and approval systems to make the approved drug medical devices reach or close to the international advanced level with respect to efficacy, safety, and quality controllability.

The Management Standards is divided into 6 chapters, including General, Responsibility of review Department, Review Quality Management System, Review Personnel Management, Technical Review Process Management, Technical Review Support Process Management, contains 66 provisions, detailing the risk management system construction, scientific system review mechanism building, review personnel capacity building, technical review system construction and normative review requirement.

Two cores: risk management and scientific review

Multiple methods: improve review quality and efficiency