What is New?

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
2019-12-13 How to Avoid or Reduce the Clinical Trial Requirements
2019-12-06 Overview of Medical Device eRPS System in China
2019-12-02 The Implementation Progress of UDI system in China
2019-11-22 Overview of Medical Device MAH System in China
2019-11-21 Clinical Evaluation of Medical Devices in China
2019-11-15 The Pathways to Medical device registration in China
2019-11-11 Medical Device Regulatory System in China
2019-11-06 Free Webinar: China Medical Device Regulation Overview and Update
2019-11-04 [Clinical] Some suggestions for clinical trials of hemostatic products
2019-11-04 Medical Device Classification Rules in China
2019-10-24 How to apply for a CA (Certification Authority) certificate in eRPS
2019-10-21 The guidelines of the registration for the manufacture of passive implantable bone, joint and oral hard tissue
2019-10-11 Medical device unique identification (UDI) system rules were officially released
2019-09-24 CIRS Summary of attending CBIIC Conference in Suzhou on 23th September
2019-09-12 【Case Study】Infrared Thermal Imaging System Registration in China
2019-08-21 China Implements Electronic Application of Medical Device Registration
2019-08-07 CMDE Expands list of Medical Device Exempt from Clinical Trials
2019-07-30 How to Exempted from Clinical Trial for Medical Device Registration in China

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CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
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Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
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Email: md@cirs-group.com