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Amendment to Provisions for In Vitro Diagnostic Reagent Registration (Decree No. 30 of China Food and Drug Administration)
2019-12-16
The Amendment to Provisions for In Vitro Diagnostic Reagent Registration adopted at the executive meeting of China Food and Drug Administration on January 5, 2017, is hereby promulgated and shall be effective as of the date of promulgation.
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Good Clinical Practice for Medical Devices (Decree No. 25 of China Food and Drug Administration and National Health and Family Planning Commission of the People's Republic of China) (Abolished)
2019-12-16
The Provisions for Medical Device Standards adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.
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Rules for Medical Device Nomenclature (Decree No. 19 of China Food and Drug Administration)
2019-12-14
The Rules for Medical Device Nomenclature, adopted at the executive meeting of China Food and Drug Administration on December 8, 2015, is hereby promulgated and shall be effective as of April 1, 2016.
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Decree of the Ministry of Health of the People’s Republic of China
2019-12-14
The Provisions for Adverse Drug Reaction Reporting and Monitoring, adopted at the executive meeting of the Ministry of Health on December 13, 2010, is hereby promulgated and shall go into effect as of July 1, 2011.
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NMPA Issued Announcement on Five Supplementary Test Methods Including Testing Items for Abietic Acid in Chenxianghuazhi Pills
2019-11-26
As per the Drug Administration Law of the People's Republic of China and its implementing regulations, NMPA has approved and released on November 26, 2019 the regulations.
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NMPA Issued Three Guidelines for Technical Review of the Registration of Embryo Replacement Catheter in Assisted Reproduction and Others
2019-11-01
NMPA has organized the formulation of the Guidelines for Technical Review of the Registration of Embryo Replacement Catheter in Assisted Reproduction, Guidelines for Technical Review of the Registration of Methods for the Determination and Identification of Known Leachables in Medical Devices, and the Guidelines for Technical Review of the Registration and Application of Cardiopulmonary Bypass System Extracorporeal Circulation Tubes.