Article 1 In order to strengthen the supervision and management of biological materials and medical devices, to ensure the clinical use of safe and effective, to safeguard the health of the people, has formulated these measures.
Second Article The biological materials and medical devices referred to in these measures refers to the diagnosis and treatment of interventional and implanted materials and equipment.
Biological materials and medical devices varieties of management by the Ministry of Health to develop and publish.
Article 3 The State encourages scientific research and the promotion of advanced technology of biological materials and medical devices, and gives full play to their role in disease prevention and treatment and rehabilitation.
Article 4 The Ministry of Health is responsible for formulating health standards for biological materials and medical devices, promulgating technical requirements; approving clinical research; approving biological materials and medical devices, and issuing approval numbers.
Provincial health administrative departments are responsible for clinical research on biological materials and medical devices and approval of the initial examination of the number of health administrative departments at or above the county level to carry out health supervision of biological materials and medical devices in the area under their jurisdiction.
Article V of the new biological materials and medical devices for clinical research before the development unit must be located in the provincial health administrative department to apply. Provincial administrative departments of health after the initial examination of the Ministry of Health audit, after examination and approval by the Ministry of Health clinical research.
The Ministry of Health to make a decision within three months after receiving all the materials.
Article 6 The unit applying for clinical research shall fill in the application for clinical research and submit the following information:
(1) domestic and foreign literature;
(2) overview of the development and description of the functional principle of the product;
(3) description of the requirements for the use of the product;
(4) performance indexes and performance test reports;
(5) Quality standards and drafting instructions;
(vi) Safety evaluation report;
(vii) Animal simulation use report.
Article VII of the new biomaterials and medical devices clinical research to obtain approval, the development unit shall be designated by the Ministry of Health and the clinical research institutions to develop research programs, by the provincial health administrative department for review and approval, reported to the Ministry of Health for the record.
The development unit is responsible for providing clinical research samples.
Article VIII of the new biomaterials and medical devices should be more than two clinical research in two medical institutions, the total number of cases is generally not less than 100 cases, family planning products not less than 1,000 cases.
Long-term intervention and implantation of biological materials and medical devices in the body follow-up time shall not be less than one year, general biological materials and medical devices follow-up time shall not be less than one-third of the actual use of time.
Article IX of the production of biomaterials and medical devices, the unit must apply to the provincial health administrative department, submit the following information and test samples:
(a) declaration of clinical research data;
(b) clinical research approval;
(c) clinical research report;
(d) product instructions;
(v) product quality standards and drafting instructions;
(vi) quality system management regulations (QSR) information;
(vii) product self-inspection report.
Provincial health administrative departments after the initial review submitted to the Ministry of Health for review, after reviewing the qualified by the Ministry of Health to issue the approval number.
The Ministry of Health to make a decision within six months after receiving all the materials.
Article X. The production of biological materials and medical devices must comply with the requirements of the Quality System Management Regulations (QSR) for biological materials and medical devices promulgated by the Ministry of Health. Products must undergo quality inspection before leaving the factory, and quality tracking and adverse reaction files must be established.
Article XI of the import of biological materials and medical devices must be applied to the Ministry of Health and submit test samples and the following relevant information, the Chinese Drugs and Biological Products Inspection and Certification Laboratory qualified, reported to the Ministry of Health for examination and approval, the issuance of the approval number.
(a) the approval documents of the health administrative department of the producing country.
(ii) product specifications;
(iii) development reports and safety evaluation reports;
(iv) clinical research reports;
(v) product quality standards and drafting instructions;
(vi) quality system management regulations (QSR) information;
(vii) product self-inspection reports.
The Ministry of Health may, depending on the circumstances, require the import of biological materials and medical devices for clinical trials.
The Ministry of Health will make a decision within six months after receiving all the materials.
Article XII prohibits the importation of biological materials and medical devices with uncertain efficacy, adverse reactions or other hazards to people's health.
Article XIII of the Ministry of Health and the provincial health administrative departments to set up biological materials and medical devices expert review committee, and the declaration of biological materials and medical devices to assess and give advice.
Article XIV: Biological materials and medical devices not approved by the Ministry of Health, biological materials and medical devices that do not meet the quality standards, as well as biological materials and medical devices that the Ministry of Health has explicitly prohibited the use of shall not be listed on the market and clinical use.
Article 15 The Ministry of Health regularly issues quality bulletins. Uncertainty about the efficacy, adverse reactions or other biological materials and medical devices that endanger people's health, cancel its approval number.
Article XVI of the medical and health institutions to establish biological materials and medical equipment adverse reaction reporting system, timely report to the local health administrative department of the clinical use of adverse reactions and problems, the health administrative departments above the county level according to the situation can be decided to suspend the use of the situation will be reported to the higher level of the health administrative
department.
Medical and health institutions shall not use biological materials and medical devices without the approval number of the Ministry of Health.
Article 17 Violation of these measures, one of the following circumstances, by the health administrative department at or above the provincial level shall be given a warning, and if the circumstances are serious, shall be fined 1-3 times the illegal income (up to a maximum of 30,000 yuan); without the illegal income, shall be fined more than 1,000 yuan and less than 10,000 yuan:
(a) unauthorized and do not carry out clinical research in the designated medical institutions ;
(ii) without obtaining the approval number, unauthorized production and operation;
(iii) production and operation of products by the Ministry of Health after two announcements, but still do not meet the quality standards required.
Article XVIII of the health care institutions in violation of the relevant provisions of the approach to the use of products without the approval number of the Ministry of Health, by the health administrative department at or above the county level to give a warning to the person responsible for the fine of less than 1,000 yuan.
Article 19 violation of these measures caused serious injury or death, the parties concerned shall be investigated for legal responsibility.
Article 20 These Measures shall apply to units and individuals engaged in scientific research, production, sales and use of biological materials and medical devices within the territory of the People's Republic of China*** and the State.
Article 21 The biological materials and medical devices developed and produced by research institutes and production units belonging to the People's Liberation Army (PLA) for civilian use shall be handled in accordance with these Measures.
Article 22 These Measures shall be interpreted by the Ministry of Health of the People's Republic of China.
Article 23 These Measures shall come into force on January 1, 1998. Any relevant provisions contrary to these Measures shall be repealed at the same time.
These Measures shall come into force on January 1, 1998.