Medical devices are divided into three categories
The first category refers to the 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.
Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Management of medical devices
Article VII of the State encourages the development of new products of medical devices. New products of 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.
Class II, Class III medical device clinical trial of new products, should be in accordance with the provisions of the State Council Drug Administration, after approval.
The completion of clinical trials and through the State Council drug supervision and management department of the organization of the expert review of new medical devices, by the State Council drug supervision and management department for approval, and issued a new product certificate.
Article VIII of the national medical device production registration system.
The production of Class I medical devices, by the municipal people's government of the municipal drug supervision and management department for examination and approval, and issued a certificate of registration of product production.
The production of Class II medical devices, by the provinces, autonomous regions and municipalities directly under the Central People's Government Drug Administration for examination and approval, and issued a certificate of registration of product production.
The production of Class III medical devices, drug supervision and management department of the State Council for examination and approval, and issued a certificate of registration of product production.
The production of Class II and Class III medical devices, should be clinically validated.
Article IX Provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department is responsible for the approval of the administrative region of the second class of medical devices clinical trial or clinical verification. Drug supervision and management department of the State Council is responsible for approving the clinical trial or clinical verification of Class III medical devices.
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 consistent with the provisions of the State Council Drug Administration.
Clinical trial or clinical verification of the qualifications of medical institutions, by the State Council Drug Administration in conjunction with the State Council health administrative department.
Article 10 of the medical institutions in accordance with the clinical needs of the unit, you can develop medical devices, under the guidance of a licensed physician in the use of 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 import of medical devices, the importing unit shall provide the instructions, quality standards, test methods and other relevant information and samples of medical devices and exporting countries (regions) to approve the production and sale of documents, the State Council Drug Administration for approval and registration, to receive the import certificate of registration before applying to the Customs and Excise Department for import procedures.
Article XII of the 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.
Provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department shall accept the application from the date of 60 working days, to make a decision on whether to give registration; not registered, shall state the reasons in writing.
The State Council Drug Administration shall, within 90 working days from the date of acceptance of the application, make a decision on whether to grant registration; not registered, shall state the reasons in writing.
Article XIII of the medical device product registration certificate listed in the content of the change, the licensee shall, within 30 days from the date of change, apply for change procedures or re-registration.
Article 14 The certificate of registration of medical device products is valid for 4 years. The licensee shall apply for re-registration within 6 months before the expiration of the product registration certificate.
Continuous suspension of production for more than 2 years, the certificate of registration of product production expires.
Article 15 The production of medical devices should be in line with national standards for medical devices; there is no national standard, should be in line with the medical device industry standards.
National standards for medical devices by the State Council administrative department in charge of standardization, in conjunction with the State Council drug supervision and management department. Medical device industry standards by the State Council drug supervision and management department.
Article 16 of the medical device instructions, labeling, packaging should be consistent with relevant state standards or regulations.
Article XVII of medical devices and their packaging should be in accordance with the provisions of the State Council Drug Administration, marked with the product registration certificate number.
Article 18 The state of medical devices to implement re-evaluation and elimination system. Specific measures by the State Council drug supervision and management department of the State Council departments concerned to develop.