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

AUSTRALIA: ARTG Entry

RUSSIA: RosZdravNadzor Certificate

THAILAND: ThaiFDA Registration

MALAYSIA: Full MDA Registration Certificate

SINGAPORE: HSA Temporary Registration

CHINA: CFDA Ruling 241

VIETNAM: Ministry of Health permission to import and use

USA: FDA Certificate of Exportability (Section 802)

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


MHRA (UK): Responce to Brexit

The Agency's response to the outcome of the EU referendum.


© Gold Thread LLC, 2017