2017, medical device review policy summary

Source: medical device innovation network January, 2018 notice of the General Administration on the issuance of guiding principles for technical review of network security registration of medical devices (No 13, 2017) announcement of the General Administration on the approval and issuance of YY / T 0287-2017 requirements of medical device quality management system for laws and regulations industrial standards of medical devices (No 11, 2017) in February, 2017 2017-02-04 Circular of the State Administration of food and Drug Administration on the issuance of administrative measures for the review, communication and exchange of medical devices (Trial) (2017 No 19) 2017-02-07 amendment to administrative measures for the registration of in vitro diagnostic reagents (Order No 30 of the State Food and Drug Administration) 2017-02-08 Circular of the General Administration on the issuance of guidelines for the preparation of application materials for preferential approval of medical devices (Trial) (No 28, 2017) national medical device quality announcement (No 4, No 22, 2017) 2017-03-14 2016 medical device registration work report 2017-03-27 notice of the General Administration on the establishment of professional group of Technical Committee for classification of medical devices Sfjxg [2017] No 27 decision of the State Food and Drug Administration on adjusting the examination and approval procedures for administrative approval of some medical devices (Order No 32 of the State Food and Drug Administration) 2017-04-06 measures for the standard management of medical devices (Order No 33 of the State Food and Drug Administration) 2017-04-26 April 2017 Interpretation of the national annual report on adverse event monitoring of medical devices (2016) 2017-04-26 may 2017 Circular of the State Administration of medical devices on the issuance of guidelines for registration and application materials of shelf life of passive implantable medical devices (2017 Revision) (2017 No 75) 2017-05-26 June 2017 Notice of the general office of the General Administration of the State Food and Drug Administration on printing and distributing the administrative measures for the confidentiality of the review and approval information of medical devices of the State Food and Drug Administration Interpretation of issues related to quality management of clinical trials of medical devices interpretation of issues related to special approval procedures for innovative medical devices on July 31, 2017 Notice of the general office of the General Administration of the people's Republic of China on standardizing the work related to the product classification of medical devices opinions on deepening the reform of the review and approval system and encouraging the innovation of medical devices 2017-09-26 October 2017-10-31 notice of the General Administration on communication and exchange of clinical trial applications of medical devices to be approved (No 184 in 2017) 2017-11-14 notice of the General Administration on Issuing guiding principles for division of registration units of medical devices (No 187 in 2017) 2017-11-23 notice of the State Food and Drug Administration Announcement of the state health and Family Planning Commission on the release of the administrative measures for the conditions and filing of clinical trial institutions of medical devices (No 145, 2017) the administrative measures for the conditions and filing of clinical trial institutions of medical devices on November 24, 2017 Sfjbxg [2017] No 161 November 24, 2017