Thailand Medical Device Regulations

Regulatory compliance Thailand

Thailand Medical Device Regulations

Thai Food and Drug Administration (TFDA) is the government agency regulating medical devices, including IVDs, in Thailand.  The Medical Device Control Division (MDCD) is the office under TFDA that reviews and approves medical device notifications or licenses.  The submission of technical dossiers shall be prepared according to the harmonized Common Submission Dossier Template (CSDT) guideline.

Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019) are the pivotal regulations for medical devices and IVDs. Qserve offers services to comply with the Thailand Medical Device Regulations.

Medical Device Classification in Thailand

Thailand Medical Device Regulations

Thailand's health authority takes a risk-based classification approach for medical devices and IVDs. Devices are categorized into four classes: class I (low-risk and Animal Medical Devices), class II (Low-moderate risk), class III (Moderate-high risk), and class IV (High risk). Class I products shall be listed, class II and III shall be notified, and class IV shall be licensed. 

The classification rules presented in ‘Risk Classification of Non-In Vitro Diagnostic Medical Devices Annexed to the Notification of the Ministry of Public Health Re: Risk Classification of Medical Devices, B.E. 2562 (2019)’ must be followed to classify the medical device in one of these classes to determine a proper registration route. Contact Qserve to follow the regulatory route with Thailand Medical Device Regulations.

Registration routes Thailand

Registration process

Any person who wishes to manufacture or import medical devices for sale to Thailand shall apply for a product registration with the Thai FDA. Three pathways are available: full evaluation, the CONCISE pathway, and the RELIANCE program.

• The full evaluation is a standard listing, notification, or licensing, depending on the devices' risk classification, as mentioned in the classification section. The Thai FDA has also implemented two additional expedited routes to shorten the review time and accelerate the approval process if certain conditions are met.   
• The concise pathway is a medical device registration approach that recognizes reference agencies' approval or utilizes the WHO prequalification. 
• The reliance program is a medical device registration program that relies on approval from the Health Science Authority (HSA) Singapore.