General Administration of Quality Supervision, Inspection and Quarantine
February
Administration of Quality Supervision, Inspection and Quarantine approved the release of YY / T 0287-2017 "Medical Device Quality Management System Regulations Requirements "medical device industry standard (2017 No.11) 2017-02-04
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on the Releasing the Measures for the Administration of Communicating and Communicating the Review of Medical Devices (Trial Implementation) (2017-02-19) 2017-02-07
"Amendment of Measures for Registration of In Vitro Diagnostic Reagents" (National Food drug Order of the General Administration of Supervision No.30) 2017-02-08
General Administration on the release medical instruments Notice of Preliminary Examination and Approval of Preparation of Reporting Documents (Trial Implementation) (2017 No.28) 2017-02-16
March
National Medical Equipment Quality Bulletin (No. 4, 2017, Issue 22) 2017-03-14
2016 Medical Device Registration Report 2017-03-27
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on the Establishment of Medical Device Classification Technical Committee Notice of Food and Drug Administration [2017] No. 27 2017-03-31
April
"Decision of the State Food and Drug Administration on Adjusting the Examination and Approval Procedures of Some Items of Medical Devices Examination and Approval (Order No. 32 of the State Food and Drug Administration) 2017-04-06
"Medical Device Standard Management Measures" (State Food and Drug Administration Order No. 33) 2017-04-26
"Medical Device Standard Management Measures" Interpretation 2017-04-26
May
National Medical Equipment Adverse Event Monitoring Annual Report (FY 2016) 2017-05-10
General Administration of Quality Supervision, Inspection and Quarantine (2017 No.75) 2017-05-26 on the Guiding Principles (2017 Revision) of the Information on the Registration of Shelf Life of Passive Implantable Medical Devices
June
Notice of the General Office of the General Administration on Printing and Distributing the Administrative Measures for the Confidentiality of Examination and Approval Information on Medical Devices Approved by the State Food and Drug Administration CFDA [2017] No. 75 2017-06-02
July
General Office of the General Office on the issuance of 2017 medical device industry standard revision of the project notice Food and Drug Administration tube 〔〕 No. 2017 2017-07-12
Medical Device Clinical Trial Quality Management Related Issues Interpretation 2017-07-31
Interpretation of issues relating to the special approval process for innovative medical devices 2017-07-31
September
General Administration of Customs Notice on Dissecting Medical Device Classification (2017 No. 104)
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Notice on the Implementation of the Medical Device Classification (2017 No. 143) 2017-09-04
General Office of the General Office on regulating the classification of medical device products related to the notice Food and Drug Administration tube 〔2017〕 127th 2017-09-26
October
"Opinions on Deepening the Reform of Examination, Examination and Approval System, and Encouraging the Innovation of Medicines and Medical Devices" 2017-10-08
General Office of the public solicitation of "<医疗器械监督管理条例>Amendment (Draft Exposure Draft) Views 2017-10-31
November
Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Notice on Relevant Matters Related to Clinical Trial Applications for Approval of Medical Devices (No. 184 of 2017) 2017-11-14
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on Issuing the Guiding Principles for Registration of Medical Device Registration Units (No. 187 of 2017) 2017-11-23
Notice of the State Sanitary and Family Planning Commission of the State Food and Drug Administration on Issuing the Measures for the Administration of the Conditions and Records of Clinical Trial Facilities of Medical Devices (No. 145 of 2017) 2017-11-24
Interpretation of the Measures for the Administration of Medical Device Clinical Trial Institutions and Record Filing 2017-11-24
Notice of the General Office of the General Office on Doing a Record in the Clinical Trial Institutions of Medical Devices Food and Drug Administration Device Management [2017] No. 161 2017-11-24
