International Certifications

International Regulatory Compliance Information

Please note: Typical online retailers can not offer you a quality system that is verified by third parties, and none offer the compliances in total that we have successfully maintained, in some case for over 30 years!  Most of our competitors haven't even attempted to pass these worldwide standards for quality assurance. 

QUALITY MANAGEMENT SYSTEM

US FDA Good Manufacturing Practice (GMP) 

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.


PRODUCT CERTIFICATIONS AND APPROVALS

UNITED STATES - FDA 510(k) cleared/PMA approved devices | VIEW WEBSITE

CERTIFICATE TO FOREIGN GOVERNMENTS | VIEW


GLOBAL REGULATORY REPRESENTATIVES

Shown below are our European representatives for regulatory affairs issues and incident reporting:

Wellkang Ltd
29 Harley Street
LONDON W1G 9QR
England
United Kingdom

Wellkang.ltd.uk