Letter on Soliciting Opinions on procedures for registration of relevant medical devices

Source: CFDA 2015-9-29 food and Drug Administration of all provinces, autonomous regions and municipalities (sfdjgxb [2015] No 61): Regulations on the supervision and administration of medical devices (Order No 650 of the State Council), measures for the registration and administration of medical devices (Order No 4 of the General Administration of food and Drug Administration) No.) and other medical device regulations and supporting regulations have been officially promulgated and implemented In order to implement the requirements of relevant laws and regulations and further standardize the procedures for registration and service matters related to category III and imported category II and III medical devices in China, our company has issued the notice on six relevant working procedures, including the procedures for reissue of registration certificate of medical devices (SFDA [2007] 169) No.), notice on Issuing the procedures for applying for cancellation of medical device registration certificate (gsyjx [2007] No 634) and other documents were cleared up It is proposed to abolish three working procedures, namely, suspension of medical device registration test, clearance certificate of medical device products and extension of medical device registration certificate, and supplement of medical device registration certificate At the same time, the working procedures for the change and filing of medical device instructions were formulated Now, please organize your company to study the relevant working procedures and give feedback before October 20, 2015 Email: ylqxzc@sina.cn When sending the email, please indicate "feedback on working procedures of medical devices" in the subject of the email Letter: No.2 building, No.26 yard, Xuanwumen West Street, Xicheng District, Beijing, China, Department of device registration, State Food and drug administration, post code: 100053 Other units or individuals can feed back to our company through the above email or letter, with the same deadline Appendix: 1 Supplementary procedures for registration certificate of medical devices 2 Error correction procedures for registration certificate of medical devices 3 Application procedures for self withdrawal of registration of medical devices 4 Procedures for self cancellation of registration certificate of medical devices 5 Procedures for change and filing of medical device instructions Department of mechanical registration, food and Drug Administration 2015-09-28 (Disclosure attribute: active disclosure) sfjxxgxb [2015] No 61, Appendix 1 Docx, sfjxxb [2015] No 61, Appendix 2 Docx, sfjxxb [2015] No 61, Appendix 3 Docx, sfjxb [2015] No 61, Appendix 4 Docx, sfjxb [2015] No 61, Appendix 5 Docx