GOLD THREAD SKIN REJUVENATION TECHNOLOGY

REGULATORY COMPLIANCE

Quality Management System:

ISO 13485 quality system certification

ISO 13485:2003 certificate

US FDA Good Manufacturing Practice (GMP):

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

View our Establishment Registration on the FDA website

Product Registration and Approvals:

EUROPE: CE Marking Certificate

RUSSIA: RosZdravNadzor Certificate

THAILAND: ThaiFDA Registration

MALAYSIA: MEDVER Certificate

INDONESIA: Ministry of Health DirJen POM Certificate

USA: FDA Certificate of Exportability (Section 802)

OTHERS: GoldThread™ products currently are under regulatory review in several major international markets