"Regulations on the Supervision and Administration of Medical Devices" Article 2 In the Chinese people*** and the State engaged in the development, production, operation, use, supervision and management of medical equipment units or individuals 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 for the human body and the body is not pharmacological, immunological or metabolic means of obtaining the role of the body, but there may be involved in these means and play a certain role in supporting; the use of its intended to achieve the following purposes:< /p>
(i) the prevention, diagnosis, treatment, monitoring, and alleviation of disease;
(ii) the diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability;
(iii) the study, substitution, and regulation of anatomical or physiological processes;
(iv) the control of pregnancy.
Article 7 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.
The clinical trial of the second class, the third class of new medical device products shall be in accordance with the provisions of the State Council Drug Administration, 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, approved by the State Council drug supervision and management department, and issued a new product certificate.
Article VIII of the national medical device production registration system.
Production of Class I medical devices, by the municipal people's government of the district-level drug supervision and management department for examination and approval, and issue 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 shall be clinically verified.
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 for clinical trial or clinical verification. 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.
The clinical trial or clinical verification of the qualifications of medical institutions, 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, can develop medical devices, under the guidance of a licensed physician to use in the unit.
The second class of medical devices developed by medical institutions shall 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, shall 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 Administration for approval and registration to receive the import registration certificate 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 thirty 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 accept the application from the date of sixty 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 ninety 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.
Article XIII of the certificate of registration of medical device products listed in the content of the change, the licensee shall, within thirty days from the date of the change, apply for change procedures or re-registration.
Article XIV of the medical device product registration certificate is valid for four years. The licensee shall apply for re-registration within six months before the expiration of the product registration certificate.
Continuous suspension of production for more than two years, the product production registration certificate expires.
Article XV of 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.
The 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 set by the State Council drug supervision and management department.
Article XVI of the medical device instructions, labeling, packaging shall comply with relevant state standards or regulations.
Article XVII of the medical device and its packaging should be in accordance with the provisions of the State Council drug supervision and management department, marked with the product registration certificate number.