Notice of the General Office of the State Drug Administration on the Issuance of the 2018 Medical Device Industry Standards Formulation and Revision Project

Drug Administration Office [2018] No. 26

Food and Drug Administrations of all provinces, autonomous regions, and municipalities directly under the Central Government, China Food and Drug Inspection Institute (Medical Device Standard Management Center of the State Food and Drug Administration), Information Center of the State Food and Drug Administration, and Oral Medical Device Testing Center of Peking University School of Stomatology:

In order to implement the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, and in accordance with the requirements for the formulation and revision of medical device industry standards in the "13th Five-Year Plan for National Drug Safety", the 2018 Medical Device Industry Standards Formulation and Revision Project is now issued to you, and the relevant requirements are notified as follows:

1. The Medical Device Standard Management Center of the State Food and Drug Administration shall organize and carry out the formulation and revision of medical device industry standards in strict accordance with the "Medical Device Standard Management Measures" and "Medical Device Standard Formulation and Revision Management Specifications", strengthen the formulation and revision work and fund management, and ensure that all work tasks are completed as required.

2. All units undertaking standard formulation and revision projects shall carry out the formulation and revision of medical device industry standards in strict accordance with the "Medical Device Standard Management Measures" and "Medical Device Standard Formulation and Revision Management Specifications". They shall fully understand and master the main products involved in the formulation and revision process, and do a good job in verifying the technical content of the standards. For the revised standard projects, the content of the standard changes shall be clarified, and implementation opinions and suggestions shall be put forward on the implementation time and registration of the standards.

3. The Food and Drug Administration of all relevant provinces (autonomous regions, municipalities directly under the Central Government) shall attach great importance to and strengthen the supervision and management of the units undertaking standard formulation and revision projects in their administrative regions, and urge all relevant units to complete the drafting, verification, solicitation of opinions, technical review and approval of standards in accordance with the relevant requirements of standard formulation and revision work.

Attachment: 2018 Medical Device Industry Standard Formulation and Revision Project

For details, please see http://www.gov.cn/xinwen/2018-08/08/content_5312491.htm

Office of the State Drug Administration

August 3, 2018