Medical Device Supervision and Administration Regulations

Chapter I General Provisions Article 1 In order to strengthen the supervision and management of medical devices, to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations. Article 2 in the Chinese people *** and the State engaged in the development of medical devices, production, operation, use, supervision and management of the unit or individual, shall comply with these regulations. Article 3 The medical device referred to in these regulations, refers to the use of the human body alone or in combination with instruments, equipment, appliances, materials or other items, including the required software; its use on the human body surface and in vivo is not obtained by means of pharmacology, immunology or metabolism, but there may be involved in these means and play a certain role in assisting; the use of its intended to achieve the following purposes:

() (a) the prevention, diagnosis, treatment, guardianship, and mitigation of disease;

(b) the diagnosis, treatment, guardianship, mitigation, and compensation of injury or disability;

(d) the control of pregnancy. Article 4 The Drug Administration under the State Council is responsible for the supervision and management of medical devices throughout the country.

The drug supervision and management departments of the local people's governments at or above the county level are responsible for the supervision and management of medical devices in their administrative regions.

The State Council drug supervision and management department shall cooperate with the State Council comprehensive economic management department, the implementation of national medical device industrial policy. Article 5 The state to implement classification management of medical devices.

The first category refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices.

The second category refers to its safety, effectiveness should be controlled medical devices.

The third category refers to the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.

Medical device classification directory by the State Council Drug Administration based on medical device classification rules, the State Council health administrative department to develop, adjust and publish. Article VI production and use of medical devices for the purpose of providing specific quantitative value, shall comply with the provisions of the measurement law. Specific product catalog by the State Council Drug Administration in conjunction with the State Council administrative department of measurement to develop and publish. Chapter II Management of Medical Devices Article 7 The state encourages the development of new medical device products. New medical devices, refers to the domestic market has not yet appeared or safety, effectiveness and product mechanism has not been recognized by the domestic brand new varieties.

The clinical trial of new products of Class II and Class III medical devices shall be conducted in accordance with the provisions of the State Council drug supervision and management department, after approval.

Completion of clinical trials and through the State Council drug supervision and management department of the State Council to organize expert review of new medical device products, by the State Council drug supervision and management department for approval, and issue new product certificates. Article VIII of the state of medical devices to implement the production of product registration system.

Production of Class I medical devices, the municipal people's government by the municipal drug supervision and management department for examination and approval, and issued a certificate of registration of product production.

Production of Class II medical devices, by the provincial, autonomous regions and municipalities directly under the Central People's Government Drug Administration for examination and approval, and issue a certificate of registration of product production.

Production of Class III medical devices, by the State Council Drug Administration for examination and approval, and issued a certificate of registration of product production.

Production of Class II and Class III medical devices, should be clinically validated. Article 9 The drug administration department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for approving the clinical trial or clinical validation of Class II medical devices in the administrative region. Drug supervision and management department of the State Council is responsible for approving the third class of medical devices clinical trial or clinical verification.

Clinical trial or clinical verification should be in the provincial people's government drug supervision and management department designated medical institutions. Clinical trial or clinical verification of medical institutions, should be in line with the provisions of the State Council drug supervision and management department.

Clinical trial or clinical verification of the qualifications of the medical institutions by the State Council Drug Administration in conjunction with the State Council health administrative department. Article 10 medical institutions in accordance with the clinical needs of the unit, can develop medical devices, under the guidance of a licensed physician to use in the unit.

Medical institutions to develop the second class of medical devices, should be reported to the people's government at or above the provincial level drug supervision and management department for review and approval; medical institutions to develop the third class of medical devices, should be reported to the State Council drug supervision and management department for review and approval. Article XI of the first imported medical devices, the importing unit shall provide the medical device instructions, quality standards, test methods and other relevant information and samples and the exporting country (region) to approve the production and sale of documents, the State Council drug supervision and management department for approval and registration, to receive the import certificate of registration before applying to the Customs and Excise Department to apply for import procedures. Article XII declaration of registered medical devices, shall be submitted in accordance with the provisions of the State Council Drug Administration technical indicators, test reports and other relevant information.

The drug supervision and management department of the municipal people's government shall, within 30 working days from the date of acceptance of the application, make a decision on whether to give registration; not registered, shall state the reasons in writing.

Provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration shall, within 60 working days from the date of acceptance of the application, to make a decision on whether to grant registration; not registered, shall state the reasons in writing.

The State Council Drug Administration shall accept the application from the date of 90 working days, to make a decision on whether to give registration; not registered, shall state the reasons in writing.