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Laws & Regulations - Medical Devices - Provisions for Supervision of Medical Device Manufacturing
Provisions for Supervision of Medical Device Manufacturing
 
2012/3/20 14:42:07¡¡Source: ¡¡Hits:

Chapter I General Provisions
Article 1 The Provisions are formulated with the view to strengthening the supervision over the manufacture of medical devices, regulating order in production, and ensuring the safety and effectiveness of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices.
Article 2 Supervision of medical device manufacturing refers to that the (food and) drug regulatory departments legally examine, approve, and supervise the manufacturing conditions and process of medical device production.
Article 3 The State Food and Drug Administration shall be in charge of the supervision and administration of medical device manufacture nationwide; the (food and) drug regulatory departments at the county level or above shall be in charge of the supervision and administration of medical device manufacture in their respective administrative regions.

Chapter II Application and Approval for Establishment of Medical Device Manufacturing Enterprise
Article 4 A medical device manufacturing enterprise shall be established in compliance with the development programs and policies formulated by the State for medical device industry.
Article 5 The State Food and Drug Administration shall make specific rules for the establishment of different medical device manufacturing enterprises, in accordance with the provisions stated in the Regulations for the Supervision and Administration of Medical Devices. Different quality management standards shall be formulated and implemented for medical devices of different categories.
Article 6 Establishment of a manufacturing enterprise of Class I medical devices requires manufacturing conditions appropriate for the product. A Registration Form for Class I Medical Device Manufacturer (see Appendix 1) shall be filled in within 30 days after the receipt of business license. The local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall be informed in written form.
Article 7 Establishment of a manufacturing enterprise of Class II or/and Class III medical devices requires the following conditions:
1. People responsible for production, product quality, and technology in the enterprise shall have the professional capacities required for producing the corresponding medical devices and possess adequate knowledge of relevant laws, regulations and rules of the State on medical device supervision and administration, as well as other relevant provisions on product quality and technology. The person responsible for quality shall not concurrently hold the position of the person in charge of production;
2. The proportion of the technicians with junior titles or above, or with diplomas from technical secondary schools or above, to the total number of employees in the enterprise shall comply with the products¡¯ requirements;
3. The enterprise shall have the production equipment, production and storage areas, and environment appropriate for the products and the production scale. When producing medical devices with particular requirements on environment or equipment, etc., the national standards, industry standards and relevant provisions of the State shall be followed;
4. The enterprise shall establish quality testing institutions, and have the proper quality testing capacity for the product and production scale;
5. The enterprise shall preserve documents of laws, regulations and rules with respect to medical device manufacture and distribution, as well as relevant technical standards.
Article 8 Establishment of a manufacturing enterprise of Class II or/and Class III medical devices requires the following conditions£¬in addition to the conditions prescribed in Article 7 of the Provisions:
1. no less than two internal auditors who meet the quality management system requirements;
2. no less than two full-time technicians with an intermediate professional title or higher, or a diploma of junior college or above, in relevant majors.
Article 9 Establishing a manufacturing enterprise of Class II or/and Class III medical devices, the applicant shall submit application to the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government, where the manufacturer is located, fill in the Application Form for the Medical Device Manufacturing Enterprise License (Establishment) (see Appendix 2), and submit the following documents:
1. general information and qualification certification of the legal representative and the responsible person of the manufacturer;
2. pre-ratification notice of the to-be-established manufacturer¡¯s name, issued by the administrative authority for industry and commerce;
3. proof documents of the manufacturing sites;
4. the curriculum vitae, diplomas or title certificates of the responsible persons for  the manufacturer¡¯s production, quality, and technology; registration forms of relevant professional technicians and technical workers, which shall indicate their departments and positions; and the form on the proportions of the senior, middle-level and junior technicians;
5. the scope and varieties of the to-be-manufactured products, and the brief introduction to the relevant products;
6. a list of main manufacture equipment and testing equipment;
7. a list of documents for quality management in production;
8. The process flow diagrams for the to-be-manufactured products, which shall indicate the major control items and control points;
9. Where sterile medical devices are produced, testing reports of production environment shall be provided.
The applicant shall be responsible for the authenticity of all contents in its dossier.
Article 10 The (food and) drug regulatory departments of a province, autonomous region and municipality directly under the Central Government shall, after the receipt of applications, handle the application respectively in light of the following circumstances:
1. Where an application item is not subject to the jurisdiction of the concerned department by law, it shall immediately make a decision not to accept the application and inform the applicant to apply to other relevant administrative authorities;
2. Where an error in the application dossier can be corrected on the spot, the on-the-spot correction shall be allowed ;
3. Where the application dossier is not complete or not in compliance with the requirements of preliminary review, the (food and) drug regulatory department shall, either on site or within five working days, issue a one-off Notification on Supplementing Documents to the applicant, informing the applicant of all the contents to be supplemented; where the (food and) drug regulatory department fail to inform the applicant within the time limit, it shall accept the application as of the date the application dossier is received;
4. the application shall be accepted if the application dossier is complete and meets the requirements of preliminary review, or the applicants have submitted supplementary documents as required.
Where the (food and) drug regulatory departments of the province, autonomous region or municipality directly under the Central Government accepts or rejects the application for establishment of a medical device manufacturing enterprise, the regulatory department shall send an Acceptance Notification or a Rejection/Non-Acceptance Notification, which shall be affixed with the special stamp of the regulatory department and the date.
Article 11 As for the application for establishment of a manufacturing enterprise of Class II or/and Class III medical devices, the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall conduct examinations within 30 working days after the application acceptance, in accordance with Article 7 through Article 9 stated in the Provisions and the product quality management standards for medical devices promulgated by the State Food and Drug Administration. Where the classified implementation requirements of the product quality management standards for medical devices have not been promulgated, the application shall be examined in accordance with Article 7 through Article 9 in the Provisions.
Where an applicant is examined t

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