OUR REGULATORY COMPLIANCE

Site Regulatory Compliance
CLEARLAB SG PTE LTD ISO 9001 QMS Certification
CLEARLAB SG PTE LTD ISO 13485 Quality System Certification
CLEARLAB SG PTE LTD MDD 93/42/EEC Certification for CE Mark
MI GWANG CONTACT LENS, CO., LTD ISO 9001 QMS Certification
MI GWANG CONTACT LENS, CO., LTD ISO 13485 Quality System Certification
MI GWANG CONTACT LENS, CO., LTD MDD 93/42/EEC Certification for CE Mark

 

Site Regulatory Compliance
CLEARLAB SG PTE LTD US FDA Facility Registration and 510 (K) Device Listing
MI GWANG CONTACT LENS, CO., LTD US FDA Facility Registration and 510 (K) Device Listing
CLEARLAB US INC. US FDA Facility Registration and 510 (K) Device Listing for repackaging
CLEARLAB SG PTE LTD US FDA 21 CFR Part 820 Quality System Regulations
MI GWANG CONTACT LENS, CO., LTD US FDA 21 CFR Part 820 Quality System Regulations

For Other Countries, We will register as per customer requests

REGULATION STANDARD OR GUIDELINE COMPLIANCE