Applicable Standards & Technical Requirements


The product technical requirement for medical device shall be compiled according to the China related national standard of medical product. It is the most important document for product safety and effectiveness evaluating and the appendix of the medical device registration certificate.

CIRS offers normally used national & professional standards, and technical requirements for your convenience. Typically, most of standards we provide are in Chinese version currently, the English ones are under translation now and will be availablle for you as soon as possible. The Catalogue of Medical Devices Standard can be found here, or you can contact Mr. Edwin Wen (Edwin.wen@cirs-group.com) to search the relevant product standard.





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