International Certifications
International Regulatory Compliance Information
Please note: Typical online retailers can not offer you a quality system that has been verified by third parties, and none offer the compliances in total that we have achieved. 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