To Drug Administration of Beijing, Tianjin, Liaoning, Shanghai, Zhejiang, Shandong, Hubei, and Guangdong Provinces, NIFDC (Center for Medical Device Standards Management of NMPA), Oral Medical Device Testing Center of Peking University School of Stomatology,
For the purpose of implementing the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, and the Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity, in accordance with the standard formulation and revision efforts for the medical device industry initiated by the National Medical Products Administration, we hereby print and distribute the 2021 medical device industry standard formulation and revision plan to you. The relevant requirements are as follows:
I. All relevant provincial (municipal) administrations shall place great emphasis on, and conscientiously organize the standard undertakers of their own administrative regions to carry out the standard formulation and revision work, strengthen supervision and management, and ensure the completion of various tasks as required.
II. The Center for Medical Device Standards Management of NMPA shall earnestly organize and coordinate the technical committees and responsible technical departments of medical device standardization to carry out the standard formulation and revision work in strict accordance with the Management Practice for the Development and Revision of Medical Device Standards, strengthen business management and inspection guidance, and ensure the quality and depth of the standards.
III. The technical committee of medical device standardization and the responsible technical departments undertaking the tasks of standard formulation and revision shall properly organize the relevant efforts concerning drafting, verification, soliciting opinions and technical review of the standards, conduct extensive investigation and in-depth research, actively learn from international standards, and ensure the scientific nature, rationality, applicability of the technical content of the standard and the compliance with relevant policy requirements.
Appendix: 2021 Standard Formulation and Revision Project for Medical Device Industry
For the purpose of implementing the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, and the Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity, in accordance with the standard formulation and revision efforts for the medical device industry initiated by the National Medical Products Administration, we hereby print and distribute the 2021 medical device industry standard formulation and revision plan to you. The relevant requirements are as follows:
I. All relevant provincial (municipal) administrations shall place great emphasis on, and conscientiously organize the standard undertakers of their own administrative regions to carry out the standard formulation and revision work, strengthen supervision and management, and ensure the completion of various tasks as required.
II. The Center for Medical Device Standards Management of NMPA shall earnestly organize and coordinate the technical committees and responsible technical departments of medical device standardization to carry out the standard formulation and revision work in strict accordance with the Management Practice for the Development and Revision of Medical Device Standards, strengthen business management and inspection guidance, and ensure the quality and depth of the standards.
III. The technical committee of medical device standardization and the responsible technical departments undertaking the tasks of standard formulation and revision shall properly organize the relevant efforts concerning drafting, verification, soliciting opinions and technical review of the standards, conduct extensive investigation and in-depth research, actively learn from international standards, and ensure the scientific nature, rationality, applicability of the technical content of the standard and the compliance with relevant policy requirements.
Appendix: 2021 Standard Formulation and Revision Project for Medical Device Industry
Department of Comprehensive Affairs, Planning, and Finance Affairs, NMPA
July 2, 2021
July 2, 2021