What is New?

2017-12-12 Registration Declared Documents Requirements for Product Registration Alteration and Renewal
2017-12-11 CFDA Is About to Implement Medical Device Network Security Registration Technical Guidelines
2017-12-08 Clinical Assessment Requirements for the Clinical Trial Exampted Medical Devices
2017-12-07 CFDA Issued Administrative Measures for Medical Device Clinical Trial Institution Qualification and Filing
2017-12-01 CFDA Announced the 1st Oversea Medical Device Manufacturing Sites Inspection Results
2017-11-30 Understanding the Regulatory Framework and Procedure of Medical Device Clinical Trials in China
2017-11-29 CFDA Post-marketing Supervision-- Medical Device Quality Sampling (Nov-Jan, 2017)
2017-11-21 CFDA Issued Ten New Medical Device Registration Guidelines
2017-11-15 CFDA Accept Medical Device Oversea Clinical Trial Data (Exposure Draft)
2017-11-15 Will the Animal Test be Required for Your Medical Devices Before the Clinical Trials?
2017-11-13 Foreign Medical Device Applicants are Required to Supplement the Chinese Information to CFDA
2017-11-08 Free Webinar! Understanding the Regulatory Framework and Procedure of Medical Device Clinical Trials in China
2017-11-06 Major Changes of 'Medical Device Supervision and Administration Regulation’
2017-10-31 CIRS is to Attend MEDICA 2017
2017-10-24 Same Variety Products Comparison Clinical Evaluation Difficulties
2017-10-23 Same Variety Products Comparison for the Clinical Trials Exemption
2017-10-17 Dental Curing Light CFDA Registration Guideline
2017-10-13 CFDA Issued Five New Medical Device Registration Guidelines
2017-10-12 CIRS is to Attend MEDICA 2017
2017-10-11 Deepen the Evaluation and Approval Regulations’ Renovation and Encourage Medical Device Innovation
2017-10-10 Deepen the Evaluation and Approval Regulations’ Renovation and Encourage Medical Device Innovation
2017-10-10 30 batches of medical devices have been refused to enter the Chinese market
2017-09-29 CFDA issued seven new medical device industry standards
2017-09-27 CFDA Alteration Registration Dossier Preparation
2017-09-25 CFDA Issued Four New Medical Device Registration Guidelines

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CIRS China

Ms. Elaine (Head office)
Tel: +86-571 87206559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mrs.Emily (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