Medical Device Registration in Thailand

• The Thai Food and Drug Administration (TFDA) is the government agency in charge of regulating medical devices in Thailand.
• The Medical Device Control Division is the office of the TFDA specifically tasked with oversight of medical device affairs.

Yes, medical devices are required to be registered in Thailand before they can be sold.

Thailand follows the ASEAN risk-based classification system for medical devices. As outlined in the Ministry of Public Health’s announcement titled “Medical Device Classification According to Risk Level, B.E. 2562,” medical devices and In Vitro Diagnostics (IVDs) are categorized based on their level of risk:

– Class 1: Devices with low risk
– Class 2: Devices with low to moderate risk
– Class 3: Devices with moderate to high risk
– Class 4: Devices with high risk

1. The applicant must prepare seven required documents (see the list of required documents below) and ensure the Certificate of Free Sale and/or the Certificate of Quality System meets all the required criteria.
2. Applicants must submit the required documents to the Thai FDA service center.
3. The submitted documents are reviewed and recorded by a regulator of the Medical Device Control Division.
4. A staff member records the applicant’s files into a database system. Then, the applicant is provided with a reference number and receipt.
5. A regulator verifies the documents, if the all the submissions are correct and fulfill the required criteria, a letter for importation of general medical devices will be printed out on the back of copies of the Certificate of Free Sale. Upon signing off on all the documents, the regulator then submits the documents to the head of the Medical Device Control Division for final approval (this is generally the director or deputy secretary).
6. The applicant obtains the letter of approval for importation.

Timeline: The entire registration process can take 3-6 months for approval depending on compliance with regulations. During step 6, if the device is incomplete and does not comply with TFDA regulations, the regulator is authorized to request a revision or additional documents. The applicant must then revise and resubmit their application.

1. Applicant letter
2. Application form
3. An index for documents #1 – 13 on this list
4. Characteristics of the medical device
5. Packaging information
6. Type and quantity components
7. Intended use, warning(s), precaution(s)
8. Instruction for use
9. Storage information
10. Test report
11. Certificate of Free Sale
12. Photo copy of trade or commercial registration, copy of census, a copy of the applicant’s ID card
13. Device user manual

Timeline: about 3-6 months

1. A letter from company requesting to verify the Certificate of Free Sale.
2. Two copies of the Certificate of Free Sale and/or Certificate of Quality System for manufacturer(s).
3. A copy of the company’s registration (establishment documents) issued by the Ministry of Commerce within the six months stating the objectives of the company.
4. Letter of authorization and certified copies of the local agent’s ID card must be attached. A letter of authorization is required in all instances.
5. Product catalog or details of the product specified in the Certificate of Free Sale.
6. Copy of the establishment for importation license.
7. Detail of products in the Certificate of Free Sale indicating the medical device’s code. (The Thai FDA Handbook indicates the various codes associated with types of medical devices).

Additional documentation regarding the safety or intended use of the medical device may be required.

Timeline: about 3-6 months

No, local testing is usually not required for registration in Thailand.

No, clinical studies are generally not required for registration in Thailand.

Yes, approval in the Country of Origin is a requirement for registration in Thailand.