News & Events

2017-08-07 CFDA Issued Administrative Measures for Medical Device Clinical Trial Institution Qualification and Filing (Exposure Draft)
2017-08-04 Registration Strategy for Imported Medical Devices in China
2017-08-03 Classification and Category of Medical Devices in China
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)
Contact Us
CIRS China

Ms. Shuo Wang (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

Ms. Louise Halpin
Tel: +353 41 9806 916 | Fax: +353 41 9806 999
Email: md@cirs-group.com