Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei and Guangdong medical products administrations, National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration NMPA), Center for Medical Device Evaluation, NMPA, and Dental Medical Devices Testing Center of Peking University Hospital of Stomatology:
In order to implement the related requirements of the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability of the General Office of the State Council and the 14th Five-Year Plan for National Drug Safety and High-Quality Development, the Planned Development and Revision Projects of Medical Device Industry Standards for 2022 are hereby issued to you according to the work arrangements of the National Medical Products Administration for medical device industry standard development and revision, with the related requirements notified as follows:
I. Related provincial (municipal) administrations should pay high attention, earnestly organize standard undertaking entities within their administrative areas to develop and revise related standards, strengthen supervision and administration, and ensure the completion of the work tasks as required.
II. The Center for Medical Device Standardization Administration NMPA should earnestly organize and coordinate medical device standardization technical committees (branches) and technical entities in charge, develop and revise related standards in strict accordance with the Management Practice for the Development and Revision of Medical Device Standards, and strengthen business management and inspection and guidance, to ensure the quality and level of the standards.
III. Medical device standardization technical committees (branches) and technical entities in charge that undertake standard development and revision should organize the drafting, verification, opinion solicitation, technical review, etc. of the standards, conduct extensive research and in-depth studies, and actively draw on international standards, to ensure that the technical content of the standards is scientific, rational, applicable, and consistent with the relevant policy requirements.
Attachments:
1. Planned Development and Revision Projects of Compulsory Medical Device Industry Standards for 2022
2. Planned Development and Revision Projects of Recommended Medical Device Industry Standards for 2022
In order to implement the related requirements of the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability of the General Office of the State Council and the 14th Five-Year Plan for National Drug Safety and High-Quality Development, the Planned Development and Revision Projects of Medical Device Industry Standards for 2022 are hereby issued to you according to the work arrangements of the National Medical Products Administration for medical device industry standard development and revision, with the related requirements notified as follows:
I. Related provincial (municipal) administrations should pay high attention, earnestly organize standard undertaking entities within their administrative areas to develop and revise related standards, strengthen supervision and administration, and ensure the completion of the work tasks as required.
II. The Center for Medical Device Standardization Administration NMPA should earnestly organize and coordinate medical device standardization technical committees (branches) and technical entities in charge, develop and revise related standards in strict accordance with the Management Practice for the Development and Revision of Medical Device Standards, and strengthen business management and inspection and guidance, to ensure the quality and level of the standards.
III. Medical device standardization technical committees (branches) and technical entities in charge that undertake standard development and revision should organize the drafting, verification, opinion solicitation, technical review, etc. of the standards, conduct extensive research and in-depth studies, and actively draw on international standards, to ensure that the technical content of the standards is scientific, rational, applicable, and consistent with the relevant policy requirements.
Attachments:
1. Planned Development and Revision Projects of Compulsory Medical Device Industry Standards for 2022
2. Planned Development and Revision Projects of Recommended Medical Device Industry Standards for 2022
Comprehensive Division of National Medical Products Administration
April 25, 2022
April 25, 2022