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Intravascular Ultrasound Diagnostic Equipment and Disposable Intravascular Ultrasound Diagnostic Catheter approved for marketing
2023-04-28
Recently, the innovative products "Intravascular Ultrasound Diagnostic Equipment" of SonoScape Medical Corp. and "Disposable Intravascular Ultrasound Diagnostic Catheter" of Shanghai Acoustic Life Science Co., Ltd are approved for marketing by China NMPA.
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Provisions for Administration of Medical Device Recall
2022-10-25
Promulgated by Decree No. 29 of the China Food and Drug Administration on January 25, 2017, these Provisions shall be effective as of May 1, 2017.
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Provisions for Supervision and Administration of Medical Device Manufacturing
2022-09-30
Promulgated by Decree No. 53 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.
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Provisions for Supervision and Administration of Medical Device Distribution
2022-09-30
Promulgated by Decree No. 54 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.
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NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination Products with Device Taking Primary Mode of Action
2022-01-17
National Medical Products Administration has set the technical evaluation of drug-device combination products as a research project in regulatory science, and organized to formulate the Guideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action.
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NMPA Announcement on the Emergency Approval Procedure for Medical Devices
2021-12-29
National Medical Products Administration organized to revise the Emergency Approval Procedure for Medical Devices, which is issued and take effect as of December 29, 2021.
