China Food and Drug Administration issued the Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft), and the Circular on Seeking Public Opinions on Guiding Principles for Registration Technology Review of Class II Medical Devices 2017

CFDA general office sought public opinions on the Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft)

The Opinions on Deepening the Reform of Evaluation and Approval System to Encourage Innovation in Drugs and Medical Devices (hereinafter referred to as “the Opinions”) was issued jointly by the General Office of the CPC Central Committee and the General Office of the State Council on October 1, which include 36 major reform measures. To ensure the implementation of reform measures with a legal basis, China Food and Drug Administration carefully studied the Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to as “the Regulation”) that need to be amended. At the same time, it solved the prominent problems that restricted effective regulation of medical devices, revised the terms of the Regulation that were in conflict with the reform measured of the Opinions, supplemented and improved the legal basis for the reform measures, solved regulatory problems, and provided strong legal support for reform and regulatory practice. China Food and Drug Administration also issued the Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft), and now seeks public opinions. Any comment and suggestion on the reform measures of the Opinions are welcomed. Please send the comments and suggestions via email to the Legislation Division of China Food and Drug Administration before November 12, 2017 and specify "Amendments to Regulation on the Supervision and Administration of Medical Devices”.

Email: xuxy@cfda.gov.cn

Appendix:

1.Instruction of the Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft)

2. Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft)

3. Revised version of the Amendments to Regulation on the Supervision and Administration of Medical Devices (Draft)

General Office of China Food and Drug Administration

October 31, 2017

Circular on Seeking Public Opinions on Guiding Principles for Registration Technology Review of Class II Medical Devices 2017

To all concerned,

We prepared 22 guiding principles for registration technology review of class II medical devices, including Guiding Principles for AST (Appendix 1) (Draft) according to relevant requirements in 2017 of China Food and Drug Administration, and seek public opinions on the website from now on. For any comments and suggestions, please complete the Comments Feedback Form (Appendix 2) and send to the contact (Appendix 3) before November 15, 2017.

Appendix:

1. 22 Guiding Principles for Registration Technology Review of Class II Medical Devices, including Guiding Principles for AST (download)

2. Comments Feedback Form (download)

3. Contact information (download)

Center for Medical Device Evaluation, China Food and Drug Administration

October 31, 2017