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

2017-08-02 How to Determine if Clinical Trials Needed for Medical Device Registration in China

2017-08-01 IVD Registration Unit

2017-07-25 Innovated Medical Devices CFDA Priority Approval

2017-07-20 How to Compile Clinical Evaluation for Clinical Trial Required Medical Device Software

2017-07-18 How to Compile Clinical Evaluation Documents for Clinical Trial Exempted Medical Device Software

2017-07-13 CFDA Medical Device Regulations Updated in 2017

2017-07-11 The CFDA Registration Procedure of Wearable Medical Devices

2017-07-06 Wearable Medical Device Registration Unit（key points of active medical device registration unit）

2017-07-04 Free Webinar：Quick Tutorial! Imported Class I Medical Devices Record Keeping in China

2017-06-27 Medical Device Software Version Naming Rules

2017-06-27 Software Components VS. Independent Software

2017-06-23 Wearable Medical Device Registration in China

2017-06-20 How to Confirm the CFDA Registration Unit for Medical Device Software

2017-06-16 How to Compile Medical Device Software Registration Application Dossiers.

2017-06-13 Preparation of Medical Device Technical Requirements

2017-06-07 Medical Device Software CFDA Registration

2017-06-02 How to Compile Medical Device Software Describing Documents for CFDA Registration (with the sample document created by CIRS)

2017-05-27 Medical Device Software Version Monitoring and Case Study

2017-05-19 No More Clinical Trials for Some Class II and III Medical Devices Registration in CFDA (Updated Version)

2017-05-18 Full Life Circle Management for the New Medical Devices

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Services

Contact Us

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