Regulations on the Supervision and Administration of Medical Devices Article 2 Units or individuals engaged in the research, production, management, use, supervision and administration of medical devices within the territory of People's Republic of China (PRC) shall abide by these regulations.
Article 3 The term "medical devices" as mentioned in these Regulations refers to instruments, equipment, appliances, materials or other articles used alone or in combination, including required software. Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its purpose is to achieve the following expected purposes:
(1) Prevention, diagnosis, treatment, monitoring and mitigation of diseases;
(2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;
(3) research, substitution and adjustment of anatomical or physiological processes;
(4) Pregnancy control.
Article 7 The State encourages the development of new medical devices. New medical device products refer to brand-new varieties that have not appeared in the domestic market or whose safety, effectiveness and product mechanism have not been recognized in China.
Clinical trials of new products of Class II and Class III medical devices shall be conducted after approval in accordance with the provisions of the drug supervision and administration department of the State Council.
New medical devices that have completed clinical trials and passed the expert review organized by the drug supervision and administration department of the State Council shall be approved by the drug supervision and administration department of the State Council, and a new product certificate shall be issued.
Article 8 The State implements a product registration system for medical devices.
The production of Class I medical devices shall be examined and approved by the pharmaceutical supervisory and administrative department of the municipal people's government with districts, and a product production registration certificate shall be issued.
The production of Class II medical devices shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a product production registration certificate shall be issued.
The production of Class III medical devices shall be examined and approved by the drug supervision and administration department of the State Council, and a product production registration certificate shall be issued.
The production of Class II and Class III medical devices shall pass clinical verification.
Article 9 The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for examining and approving the clinical trials or clinical verification of Class II medical devices within their respective administrative areas. The State Council drug supervision and administration department is responsible for the examination and approval of clinical trials or clinical verification of Class III medical devices.
Clinical trials or clinical verification shall be conducted in medical institutions designated by the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level. Medical institutions conducting clinical trials or clinical verification shall comply with the provisions of the drug supervision and administration department of the State Council.
The qualification for clinical trial or clinical verification of medical institutions shall be determined by the drug supervision and administration department of the State Council in conjunction with the health administrative department of the State Council.
Article 10 Medical institutions may, according to the clinical needs of their own units and under the guidance of medical practitioners, develop medical devices used by their own units.
The development of Class II medical devices by medical institutions shall be reported to the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level for examination and approval; The development of Class III medical devices by medical institutions shall be reported to the drug supervision and administration department of the State Council for examination and approval.
Article 11 For the medical devices imported for the first time, the importer shall provide the instructions, quality standards, inspection methods and other relevant materials and samples of the medical devices, as well as the certification documents of the exporting country (region) approving the production and sales. Only after the drug supervision and administration department of the State Council has approved the registration and obtained the import registration certificate can it apply to the customs for handling the import formalities.
Article 12 To apply for registration of medical devices, technical indicators, inspection reports and other relevant materials shall be submitted in accordance with the provisions of the drug supervision and administration department of the State Council.
The pharmaceutical supervisory and administrative department of the municipal people's government with districts shall make a decision on whether to approve the registration within 30 working days from the date of accepting the application; If the registration is not granted, the reasons shall be explained in writing.
The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision on whether to approve the registration within 60 working days from the date of accepting the application; If the registration is not granted, the reasons shall be explained in writing.
The drug supervision and administration department of the State Council shall make a decision on whether to approve the registration within 90 working days from the date of accepting the application; If the registration is not granted, the reasons shall be explained in writing.
Article 13 If the contents listed in the medical device product registration certificate change, the holder shall apply for change or re-registration within 30 days from the date of change.
Fourteenth medical device product registration certificate is valid for four years. The holder shall apply for re-registration within 6 months before the expiration of the product registration certificate.
If the production is stopped for more than 2 years, the product production registration certificate will automatically become invalid.
Article 15 The production of medical devices shall conform to the national standards for medical devices; If there is no national standard, it shall conform to the medical device industry standard.
The national standards for medical devices shall be formulated by the standardization administrative department of the State Council in conjunction with the drug supervision and administration department of the State Council. The industry standard of medical devices shall be formulated by the drug supervision and administration department of the State Council.
Article 16 Instructions for use, labels and packaging of medical devices shall conform to relevant national standards or regulations.
Seventeenth medical devices and their packaging shall be marked with the product registration certificate number in accordance with the provisions of the drug supervision and administration department of the State Council.