Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of medical device production. Article IV The State Food and Drug Administration to develop quality management standards for the production of medical devices and supervise the implementation. Article 5 The food and drug supervision and management departments in accordance with the law and timely release of medical device production licensing and filing of relevant information. Applicants can inquire about the progress of approval and approval results; the public can access the approval results. Article 6 The medical device manufacturer shall be responsible for the quality of medical devices produced. Commissioned production, the commissioning party is responsible for the quality of the commissioned production of medical devices. Chapter II production license and record management Article 7 engaged in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel;
(b) the production of medical devices to carry out quality inspection of the institution or full-time inspectors and inspection equipment;
(c) to ensure the quality of medical devices. (C) have to ensure the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements. Article VIII to open the second class, the third class of medical device manufacturers, shall apply to the local provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for production permits, and submit the following information:
(a) a copy of the business license, organization code certificate;
(b) the applicant holds the production of medical devices and product registration certificate and a copy of the technical requirements of the product;
(C) legal representative, a copy of the identity of the person in charge of the enterprise;
(D) production, quality and technical personnel in charge of the identity of the person, academic qualifications, certificates of title;
(E) production and management, quality inspection positions of practitioners in the academic qualifications, titles list;
(F) the production site of the documents, there are special requirements for the production environment should also be Submit a copy of the facilities, environmental documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the person in charge;
(xi) other supporting information. Article IX Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, upon receipt of the application, according to the following circumstances, respectively, to deal with:
(a) the application matters within its terms of reference, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not comply with the statutory form, it shall be on the spot or within five working days at a time Inform the applicant of all the contents that need to be corrected, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) If there are errors in the application information that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) If the application does not fall within the scope of competence of the department, the application shall be made instantly inadmissible and the applicant shall be informed to the relevant administrative departments to Application.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration acceptance or inadmissibility of applications for authorization to manufacture medical devices, shall issue a notice of acceptance or inadmissibility. Article 10 The province, autonomous region, municipality directly under the Central Food and Drug Administration shall, within 30 working days from the date of acceptance of the application information for review, and in accordance with the requirements of the quality management standard for the production of medical devices to carry out on-site verification. On-site verification should be based on the situation, to avoid duplication of verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "Medical Device Manufacturing License"; does not meet the prescribed conditions, make a written decision not to permit, and the reasons. Article XI to open the first class of medical device manufacturers, should be located in the municipal food and drug supervision and management department for the first class of medical equipment production record, submit the record held by the company to produce a copy of the medical device filing certificate and the information provided in Article 8 of these measures (except for the second item).
The food and drug supervision and management department shall submit information on the integrity of the enterprise on the spot to check, in line with the prescribed conditions to be filed, issued by the first class of medical devices production filing voucher. Article XII of the medical device production license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of the medical device production license, the food and drug supervision and management department believes that involves the interests of the public ******************************************************************. Significant licensing matters, should be announced to the community, and hold a hearing.