State Food and Drug Administration: 86 medical device standards changed


On May 19, the State Food and Drug Administration issued the "Notice on Printing and Distributing the 2020 Medical Device Industry Standards Revision Plan Project", and many industry standards have changed.

In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" of the General Office of the CPC Central Committee and the General Office of the State Council, in accordance with the requirements of the "13th Five-Year" National Drug Safety Plan for the development of medical device industry standards, The relevant requirements are notified as follows:

1. All relevant provincial (municipal) bureaus should attach great importance to and seriously organize standard undertaking units in their administrative regions to carry out standard system revision work, strengthen supervision and management, and ensure that all work tasks are completed as required.

2. The Medical Device Standards Management Center of the State Food and Drug Administration should seriously organize and coordinate the medical device standardization technical committees and technical focal units, strictly follow the "Medical Device Standards and Revision Work Management Regulations" to carry out standard system revision work, and strengthen business management and inspection guidance. To ensure standard quality and level.

3. The Medical Device Standardization Technical Committee and the technical focal unit that undertakes the task of standard preparation and revision shall do a good job in organizing the drafting, verification, solicitation of opinions, and technical review of the standards, extensively listen to opinions, strengthen communication and coordination with relevant parties, and ensure standard technology The content is scientific, reasonable, applicable, and conforms to relevant policy requirements.