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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.
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NMPA Announcement on the Issuance of 21 Medical Device Industry Standards such as YY / T 0464-2019 Single-Use Hemoperfutor and 1 Modification Order
2019-11-13
On November 13, 2019, NMPA issued the Announcement on 21 Medical Device Industry Standards such as YY/T 0464- 2019 Single-Use Hemoperfutor and 1 Modification Order. For the codes, names, scope of application and implementation date of the standards.
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NMPA Announcement on the Issuance of 13 Guidelines for Technical Review of the Registration of Augmented Extremity Compression Therapy Equipment and Others
2019-11-15
To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on November 15, 2019 the Guidelines.