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|
|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|