Thailand Medical Device Regulations

Agency
All medical devices are regulated by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA).
Medical Device Definition
Medical device means (1) Equipment, products or articles used in the medical profession; the profession of nursing and midwifery, of the clinical practice of medicine or of veterinary as prescribed by the legislation concerned; (2) Equipment, products or articles that have effects on the health, the structure or any functions of the human or animal body; (3) Constituents, components, accessories or parts of the equipment, products or articles under (1) or (2); (4) Other equipment, products or articles prescribed by the Minister as medical device by publication in the Government Gazette; "Produce" means make, assemble or devise; repackage separately or collectively; as well as recycle by transmuting, modifying or sterilizing.
Classification of Medical Device
Classification Type of Device Examples RIsk Level Type of Regulation
Class 1 Licensed Medical Devices  syringes, contact lens, surgical gloves and IVDs. High Require license for sale. Must show compliance with Thai Industrial Standards
Class 2 Notified Medical Devices Physical therapy devices Alcohol detector Implanted Silicone Breast Prosthesis Moderate Must register with TFDA but do not require license.
Class 3 General Medical Devices (lowest risk) This Category includes about 90% of medical devices Low Must be validated by the Thai FDA
Premarket Approval Process
Class 1 Class 2 Class 3
3-6 months 3-6 months 7 to 10 days
 Prepare application dossier. This includes: Certificate of Analysis from the Department of Medical Sciences (DMSc), stability data, clinical study and/or evaluation data, Thai label and leaflet, product formulae, and production processes. Prepare application dossier. This should include the same documents as Class 1 devices in addition to test results from DMSc Class 3 devices do not require a license. Documents to be submitted: product description/information, the catalogue, and the CFS are required. If sterile: ISO certification required.
Documents will be reviewed by MDCD and if verified, device will receive letter of approval for importation.
Additional Information
Validity 3 years
Costs Registration Cost: USD $100 - $700
Local Testing Not required
Clinical Studies Not required
Post Market Surveillance TFDA conducts random post-marketing audits TDFA requires annual reports on manufacturing, importing or selling medical devices