Thai FDA (Thailand Food and Drug Administration)

Thailand’s Food and Drug Administration, commonly known as Thai FDA, is the national regulatory authority responsible for protecting public health and ensuring the safety, quality, and efficacy of health-related products, including foods, pharmaceuticals, medical devices, cosmetics, herbal products, narcotics, psychotropic substances, hazardous chemicals, and volatile substances. The agency operates under the Ministry of Public Health and is supported by expert committees covering specialties such as medical devices, drugs, food, and cosmetics.  

The Thai FDA has comprehensive regulatory oversight throughout the product lifecycle through its Medical Device Control Division (MDCD). It's pre-market activities include evaluating product safety, effectiveness, and quality prior to authorizing market entry according to current regulations. The agency manages post-market surveillance and vigilance, which includes monitoring adverse events, coordinating recalls, and conducting inspections to enforce compliance. The Thai FDA also oversees the licensing of establishments and dealers, supervises the import and export of regulated goods, and regulates product labelling and advertising.

When was the Thai FDA established?

Thailand's Food and Drug Administration was established in 1974 and celebrated its 50th anniversary on 11 December 2024.

What is the difference between the Thai FDA and the Thai Medical Device Control Division (MDCD)?

The Thai FDA is the government authority for health products in general, while the Medical Device Control Division (MDCD) is the operation within the Thai FDA tasked with managing regulations, registrations, and enforcement specifically for medical devices (similar to the Center for Devices and Radiological Health (CDRH) within the US FDA).

Does the Thai FDA charge fees for medical device registration?

Yes, Thai FDA charges fees for various activities, including registration submission, expert review, approvals, renewals, and facilities inspections. Fees vary by device risk classification (higher risk devices come with higher fees).

How can I contact the Thai FDA?

Thai FDA operates a general hotline that accepts call from within Thailand by calling 1556 (ext. 1). Calls from outside Thailand should contact (66) 2590 7000. Consumer complaints should be sent to 1556@fda.moph.go.th.

Website: Thai FDA
Address: 88/24 Tiwanon Road, Mueang District, Nonthaburi 11000 THAILAND
Phone: (66) 2590 7000
Email: saraban@fda.moph.go.th