News & Events

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

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

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