1. What relevant regulatory documents are involved in the production quality management specifications of medical devices?
(1) Regulations on the supervision and administration of medical devices (Order No. 680 of the State Council of the people's Republic of China);
(2) Administrative measures for registration of medical devices (Article 34 and Article 51 of order No. 4 of the State Food and Drug Administration);
(3) Administrative measures for registration of in vitro diagnostic reagents (Article 44 and Article 63 of Decree No. 5 of the State Food and Drug Administration);
(4) Measures for the supervision and administration of the production of medical devices (Order No. 7 of the State Food and Drug Administration);
(5) Announcement of the State Food and Drug Administration on the release of the production quality management specifications for medical devices (2014 No. 64);
(6) Notice of the State Food and Drug Administration on the release of sterile medical devices in the appendix of the production quality management specifications for medical devices (2015 No. 101);
(7) Announcement of the State Food and Drug Administration on the release of implantable medical devices in the appendix of the production quality management specification for medical devices (No. 102, 2015);
(8) Announcement of the State Food and Drug Administration on the release of in vitro diagnostic reagents in the appendix of the production quality management specifications for medical devices (2015 No. 103);
(9) Notice of the State Food and Drug Administration on the release of customized dentures in the appendix of the production quality management specification for medical devices (2016 No. 195);
(10) Notice of the State Food and Drug Administration on relevant matters concerning the implementation of the production quality management specifications of medical devices (Notice No. 15, 2014 of the State Food and Drug Administration);
(11) Notice of the State Food and Drug Administration on printing and distributing the verification procedures (Provisional) for the registration quality management system of class III medical devices in China (sfjxg [2015] No. 63);
(12) Notice of the State Food and Drug Administration on printing and distributing four guiding principles, including the guiding principles for on-site inspection of the production quality management specifications of medical devices (sfjxj [2015] No. 218); (13) Circular of the State Food and Drug Administration on issues related to the implementation of the quality management standards for the production of medical devices by category III medical device manufacturers (Circular of the State Food and drug administration, 2016, No. 19); (14) Notice of the general office of the food and Drug Administration on the implementation of the quality management standards for the production of medical devices by the third category of medical device manufacturers (sfdjhxj [2016] No. 12);
(15) Notice of the State Food and Drug Administration on printing and distributing the guiding principles of customized denture on-site inspection for the production quality management of medical devices (sfjxj [2016] No. 165);
(16) Notice of the general office of the food and Drug Administration on the work related to the implementation of the quality management specifications for the production of medical devices by class I and class II medical device manufacturers (sfdjbjxj [2017] No. 120);
(17) Notice of Beijing food and Drug Administration on the full implementation of the production quality management standards of medical devices (jsyjxj [2016] No. 10);
(18) Notice of Beijing food and Drug Administration on printing and distributing the measures of Beijing Municipality for rapid review and approval of medical devices (Trial) (jsjxj [2016] No. 36);
(19) Notice of Beijing food and Drug Administration on the implementation of quality management standards for medical device production (Circular [2017] No.9). 2. What is the scope of application of medical device production quality management specifications? Regulations on supervision and management of medical devices and other regulatory documents clearly define the legal status of production quality management norms of medical devices:
(1) It is applicable to the verification of quality management system related to the development and production of medical device products in the process of technical review of product registration;
(2) It is applicable to on-site verification of medical device production license;
(3) It is applicable to all kinds of supervision and inspection on the operation of quality management system of production enterprises.
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