Regulations on the Supervision and Administration of Medical Devices
Regulations on the Supervision and Administration of Medical Devices
Regulations on the Supervision and Administration of Medical Devices
Order of the State Council [1999] No. 276
January 4, 2000
The Regulations on the Supervision and Administration of Medical Devices, which were adopted at the 24th executive meeting of the State Council on December 28, 1999, are hereby promulgated and shall come into force as of April 1, 2000.
Appendix: Regulations on the Supervision and Administration of Medical Devices
Chapter I General Regulations
Article 1 These Regulations are formulated for the purposes of strengthening the supervision and administration of medical devices, guaranteeing the safety and effectiveness of medical devices and guaranteeing the human health and safety of lives.
Article 2 Any unit or individual engaged in the research and development, production, operation, use, or supervision and administration of medical devices shall comply with these Regulations.
Article 3 The medical devices as mentioned in these Regulations shall refer to any instrument, apparatus, appliance, material or other articles including the necessary software, used on human body whether used alone or in combination, which does not play its role on or within the human body by means of pharmacology, immunology or metabolism, but which may play a certain supporting role together with these means; the use of medical devices is to achieve the following expected aims:
1. Prevention, diagnosis, treatment, monitoring or alleviation of disease;
2. Diagnosis, treatment, monitoring, alleviation of or compensation for injuries or handicap conditions;
3. Investigation, replacement or modification of anatomy or a physiological process; and
4. Control of conception.
Article 4 The drug supervision and administration department of the State Council shall be responsible for the supervision and administration of medical devices throughout the country.
The drug supervision and administration departments of the local people's governments at and above county level shall be responsible for the supervision and administration of medical devices within their respective administrative regions.
The drug supervision and administration department of the State Council shall coordinate with the comprehensive department of economy of the State Council to implement the national industrial policy on medical devices.
Article 5 The state adopts classified administration for medical devices.
Class I medical devices shall refer to those devices whose safety and effectiveness can be guaranteed through routine administration.
Class II medical devices shall refer to those devices whose safety and effectiveness should be controlled.
Class III medical devices shall refer to those devices which are implanted into the human body, or used for life support or sustenance, which may pose potential risk to the human body, and the safety and effectiveness of which must be strictly controlled.
The classification contents for medical devices shall be formulated, adjusted and promulgated by the hygiene administrative department of the State Council in accordance with classification rules of medical devices issued by the drug supervision and administration department of the State Council.
Article 6 The medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metrology law. The detailed product list shall be formulated and promulgated by the drug supervision and administration department of the State Council in conjunction with the metrology administrative department of the State Council.
Chapter II Administration of Medical Devices
Article 7 The state encourages the research and development of new medical devices. The term "new medical devices" shall refer to the brand new products which are not available in the domestic market, or whose safety, effectiveness and product mechanism have not been recognized within China.
The clinical trials of new medical devices of Class II and Class III shall, upon approval, be conducted in accordance with the provisions of the drug supervision and administration department of the State Council.
The new medical devices that have gone through clinical trials, and have passed experts' evaluation and review organized by the drug supervision and administration department of the State Council, shall be granted the new product certificate after being approved by the drug supervision and administration department of the State Council.
Article 8 The state practices the product registration system for the production of medical devices.
To produce Class I medical devices, the drug supervision and administration departments of the people's governments of the cities with districts shall handle the examination and approval, and shall grant the production registration certificate of product to producing enterprises.
To produce Class II medical devices, the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall handle the examination and approval, and shall grant the production registration certificate of product to producing enterprises.
To produce Class III medical devices, the drug supervision and administration department of the State Council shall handle the examination and approval, and shall grant the production registration certificate of product.
Clinical trials shall be passed to produce Class II and Class III medical devices.
Article 9 The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the examination and approval of the clinical trials or clinical verifications of Class II medical devices within their respective administrative regions. The drug supervision and administration department of the State Council shall be responsible for the examination and approval of the clinical trials or clinical verifications of Class III medical devices.
The clinical trials or clinical verifications of Class III medical devices shall be conducted by medical institutions designated by the people's government at or above provincial level.
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