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2020-09-20
Guidance on Requirements for Reporting and investigation of Incidents and Adverse Events of Medical Devices
2020-09-16
SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)
2020-09-10
Guidance on Requirements for Clinical Investigations (Trials) of Medical Devices
2020-09-07
Temporary Guidance on Corona Virus (Covid-19) IVD Tests - Emergency Use Authorization (EUA)
2020-09-06
Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices
2020-09-02
Guidance on Requirements for Performance Evaluation Studies of In Vitro Diagnostics Medical Devices (PESIVD)
2020-09-02
Guidance on Requirements for Medical Device Listing and Marketing Authorization
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