杭州瑞旭科技集团有限公司

Regulatory Consulting for China Medical Device - 杭州瑞旭科技集团有限公司

News & Events

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

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

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CIRS China

Ms Yolanda Yan (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
Tel: +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee
Tel: +82 2 6347 8801
Email: md@cirs-group.com