In order to implement the Advice on Deepening the Reform of Evaluation and Approval System to Encourage Innovation in Drugs and Medical Devices (TZ No. [2017] 42) by the General Office of the CPC Central Committee and the General Office of the State Council, the CFDA organized the revision and issued the Management Practices for the Revision of the Standard System of Medical Devices in accordance with the Methods for Medical Device Standard Management (Order of the CFDA No. 33).
The Management Practices consists of 12 chapters and 63 clauses, including project preparation, standard drafting, verification, solicitation of opinions, technical review, examination and approval and release, implementation and evaluation, modification and corrigendum, review and abolition. The Management Practices, a supporting document of Methods for Medical Device Standard Management, complements the requirements of the whole process of revising the standard system and has strong guidance and operability.
Medical device standard is a technical specification commonly followed by the development, production, operation, use and supervision and management of medical devices. It is also an important technical support for medical device regulation and industrial development. The implementation of Management Practices will further strengthen the standardization and fine management of the revising the standard system of medical devices, playing a positive role in promoting the standardization of medical device management and improving the standard quality of medical devices.