ISO 13485 Quality System Certification

We are fully compliant with the requirements of ISO13485:2003 and get the certificate issued by TUV.

 

China SFDA Good Manufacturing Practice (GMP)

We are fully compliant with China SFDA Quality Systems Regulations.

 

Drug Production License

We have obtained Drug Production License issued by the Chinese State Food and Drug Administration (SFDA)

 

Medical Device Production License

We have obtained Medical Device Production License issued by Chinese State Food and Drug Administration (SFDA)

 

PRODUCT CERTIFICATIONS AND APPROVALS

Our following products are approved by Chinese State Food and Drug Administration (SFDA)

EUROPE - Declarations of Conformity

EUROPE - Authorized Representative

Emergo Europe, The Hague, NETHERLANDS

Telephone: +31.70.345.8570

http://www.EmergoGroup.com