Regulations & Know-how

CIRS will perform as your local representative and work with you to design and implement a competitive and cost-efficient regulatory strategy for your medical devices registration and market access in China.

The table below is a list of China Medical Device regulations we can help you comply with. The legislation covers medical devices Classification, Labeling and Packaging, Testing, Registration, Clinical Trial, Quality Assurance, Manufacture and Distribution, Advertisement, Post-market Monitoring, Customs Clearance, IPR Protection, etc. Most of these regulations have been or will be revised soon by Chinese government over these years to overhaul the medical devices management in China.

Services by Regulations

Sector Regulations
(Click each item for more information) 
Overview
Classification
&
Nomenclature
Labeling
&
Packaging
Product Testing
Registration
Clinical Trial (GCP)
Quality Assurance (GMP, GSP)
Manufacture
&
Distribution
Advertisement
Post-market Monitoring
Customs Clearance
  • The Management Measures for Imported Medical Device Inspection and Supervision (AQSIQ Order No. 95 2007)
IPR Protection (Patent,
Trademark, Copyright)
  • The Trademark Law of the People’s Republic of China (2013 Revision)
  • The Implementing Regulations of the Trademark Law of the People's Republic of China (2014 Revision)
  • The Patent Law of the People’s Republic of China (2008 Revision)
  • The Implementing Regulations of the Patent Law of the People’s Republic of China (2010 Revision)
  • The Copyright Law of the People’s Republic of China
  • The Implementing Regulations of the Copyright Law of the People’s Republic of China
  • The Regulations of the People's Republic of China on Customs Protection of Intellectual Property Rights (State Decree No.395 2004)
Contact Us
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