Administrative Measures for Medical Device Standards
Administrative Measures for Medical Device Standards
Administrative Measures for Medical Device Standards
Order of the China Food and Drug Administration No.33
April 17, 2017
The Administrative Measures for Medical Device Standards, which was deliberated and adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, is hereby promulgated for implementation as of July 1, 2017.
Bi Jingquan, Minister of the China Food and Drug Administration
Administrative Measures for Medical Device Standards
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Standardization Law of the People's Republic of China, the Implementing Regulations of the Standardization Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations to promote scientific and technological progress, ensure the safety and effectiveness of medical devices, enhance health security and strengthen the management of medical device standards.
Article 2 The medical device standards mentioned hereunder refer to the uniform technical standards formulated, revised, and promulgated in accordance with legal procedures by the China Food and Drug Administration (the "CFDA"), which is responsible for overseeing the research, development, production, business operation, use, supervision, management and other activities relating to medical devices.
Article 3 The formulation, revision, implementation, supervision and administration of medical device standards within the territory of the People's Republic of China shall be subject to the laws and administrative regulations of the People's Republic of China and these Measures.
Article 4 Medical device standards are classified into mandatory medical device standards (the "mandatory standards") and voluntary medical device standards (the "voluntary standards") in terms of their effectiveness.
Technical requirements that are indispensable to protect human health and life safety shall be developed into mandatory national standards and mandatory industrial standards for medical devices.
Other technical requirements that are necessary to satisfy basic and general purposes, supplement the mandatory standards and play a pioneering role in the medical device sector should be finalized as the voluntary national standards and voluntary industrial standards for medical devices.
Article 5 Medical device standards may be classified into basic standards, method standards, management standards and product standards in terms of the subjects that they regulate.
Article 6 The CFDA is responsible for formulating the plan for medical device standards, establishing the working system in the management of medical device standards and improving the management system for medical device standards.
Article 7 Enterprises, social organizations, educational or research institutions, other institutions and individuals are encouraged to extensively participate in the formulation and revision of medical device standards and supervise the implementation of medical device standards.
Article 8 Participation in international standardization activities and the formulation and adoption of international medical device standards are encouraged.
Article 9 The CFDA will commend and award organizations and individuals with outstanding performance in the work relating to medical device standards in accordance with the relevant provisions of the State.
Chapter II Management Responsibilities for Standards
Article 10 The CFDA shall perform the following responsibilities:
1.
......
Order of the China Food and Drug Administration No.33
April 17, 2017
The Administrative Measures for Medical Device Standards, which was deliberated and adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, is hereby promulgated for implementation as of July 1, 2017.
Bi Jingquan, Minister of the China Food and Drug Administration
Administrative Measures for Medical Device Standards
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Standardization Law of the People's Republic of China, the Implementing Regulations of the Standardization Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations to promote scientific and technological progress, ensure the safety and effectiveness of medical devices, enhance health security and strengthen the management of medical device standards.
Article 2 The medical device standards mentioned hereunder refer to the uniform technical standards formulated, revised, and promulgated in accordance with legal procedures by the China Food and Drug Administration (the "CFDA"), which is responsible for overseeing the research, development, production, business operation, use, supervision, management and other activities relating to medical devices.
Article 3 The formulation, revision, implementation, supervision and administration of medical device standards within the territory of the People's Republic of China shall be subject to the laws and administrative regulations of the People's Republic of China and these Measures.
Article 4 Medical device standards are classified into mandatory medical device standards (the "mandatory standards") and voluntary medical device standards (the "voluntary standards") in terms of their effectiveness.
Technical requirements that are indispensable to protect human health and life safety shall be developed into mandatory national standards and mandatory industrial standards for medical devices.
Other technical requirements that are necessary to satisfy basic and general purposes, supplement the mandatory standards and play a pioneering role in the medical device sector should be finalized as the voluntary national standards and voluntary industrial standards for medical devices.
Article 5 Medical device standards may be classified into basic standards, method standards, management standards and product standards in terms of the subjects that they regulate.
Article 6 The CFDA is responsible for formulating the plan for medical device standards, establishing the working system in the management of medical device standards and improving the management system for medical device standards.
Article 7 Enterprises, social organizations, educational or research institutions, other institutions and individuals are encouraged to extensively participate in the formulation and revision of medical device standards and supervise the implementation of medical device standards.
Article 8 Participation in international standardization activities and the formulation and adoption of international medical device standards are encouraged.
Article 9 The CFDA will commend and award organizations and individuals with outstanding performance in the work relating to medical device standards in accordance with the relevant provisions of the State.
Chapter II Management Responsibilities for Standards
Article 10 The CFDA shall perform the following responsibilities:
1.
......