What is New?

2020-08-07 [NMPA] New and Revised Catalogue of Medical Devices Exempted from Clinical Trials (Draft for Comment)
2020-06-28 The Class III Medical Devices that Need to Be Approved for Clinical Trials (Revised in 2020, Draft for Comments)
2020-06-18 [Clinical Trial] Superiority Trial of Medical Device Clinical Trial Design
2020-06-01 [Clinical Trial] Non-inferiority Trial of Medical Device Clinical Trial
2020-05-22 [Clinical Trial] Factors Affecting the Estimation of the Sample Size of Clinical Trials of Medical Devices
2020-05-13 Medical Device Overseas Clinical Trial Data for Registration in China
2020-04-30 [NMPA] The Content Adjustment of the "Medical Devices Classification Catalogue"
2020-04-10 [UDI Database] Medical Device Unique Identification Database Is Open to the Public
2020-03-31 [Important] How to Check the Registration Information of Anti-epidemic Medical Device Products
2020-03-30 China's First Medical Device Approved for Marketing by Using Domestic Clinical Real-World Data
2020-03-20 Summary of the 2019 Medical Device Registration Report
2020-03-10 【NMPA】7 New Registration Technical Review Guidelines
2020-03-05 [Analysis][NMPA] The transfer of the production of imported medical devices to Chinese enterprises
2020-03-04 [Case Study] The Registration of Medical Isolation Mask
2020-03-02 [Case Study] Medical Isolation Goggles （Eye Masks）
2020-02-28 [Case Study] The Registration of Thermometer
2020-02-27 [Case Study] The Registration of Medical Protective Masks, Surgical Masks and General Medical Masks
2020-02-24 [Case Study] The Filing of Medical Isolation Gown
2020-02-18 Technical Review Points for Registration of New Coronavirus Nucleic Acid Detection Reagents(COVID-19)
2020-02-11 Detailed Explanations of Emergency Approval Procedures for Medical Device
2020-01-17 NMPA Releases New and Revised Catalogues of Medical Devices and IVD Reagents Exempt from Clinical Trials
2020-01-09 China Human Genetic Resources Management Office Streamlines Approval Process for Some Projects
2020-01-03 [Summary] Major New Regulations of Medical Device Industry Issued in 2019
2019-12-26 Medical Device Unique Identification (UDI) Database Comes Online
2019-12-20 Material Requirements for Different Evaluation Paths of Medical Devices

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