What is New?

2021-03-04 【CMDE】Product Technical Requirements and Registration Testing
2021-03-03 【CMDE】Medical Device Registration System
2021-02-08 2020 Medical Device Registration Work Report
2021-02-05 【Free Webinar】Overview of Chinese Medical Device Regulations - Korea Branch
2021-02-01 Registration Application of Software Medical Device
2021-01-22 Free Webinar: Overview and Update of Medical Device Clinical Trial Regulations in 2020
2021-01-13 Free Webinar: An Overview of China and Europe Medical Device Regulations with Case Study on Surgical Mask
2021-01-04 【NMPA】The results of Sampling Inspection of Medical Device Supervision (No.5)
2020-12-23 The Regulations on Supervision and Administration of Medical Devices (Revised Draft) was adopted
2020-11-27 Technical Guidelines of use IVD overseas Clinical Trial Data (draft for comment)
2020-11-20 【NMPA】Announcement on Approval of 73 Medical Device in October
2020-11-16 NMPA - An Interpretation on Drug and Medical Device Combination Product
2020-11-04 【NMPA】 Analysis of the Related Matters about Imported Medical Devices Manufacturing in China (Announcement NO.40 2020)
2020-10-30 CFDA, NMPA Guideline for Medical Device Registration in China
2020-10-29 【NMPA】Announcement on the Production of Imported Medical Devices in China related matters (NO.104, 2020)
2020-10-28 NMPA, Announcement on Imported Certificated Medical Devices product Transfer to Domestic Production in China
2020-09-21 The Revision of Class III Medical Devices that Need to be Approved for Clinical Trial ( revised in 2020)
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

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