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.
Medical devices in Thailand is classified into 3 categories namely Class I, II and III.
Medical devices in Thailand is classified into 3 categories namely Class I, II and III.
Unlike the risk classification convention adopted by most countries, category I devices in Thailand are considered the riskiest medical device and category III devices are considered the lowest risk device.
For Licence and Notification of medical device application, Thai FDA expects the dossier to be submitted in Common Submission Dossier Template (CSDT) format.
For Licence and Notification of medical device application, Thai FDA expects the dossier to be submitted in Common Submission Dossier Template (CSDT) format.
How to register for your medical device in Thailand
Timeline Class I: eight to ten months
Class II: six to eight months
Class III: two to six days
Certificate Validity
Class I and Class II medical devices: five years
Class III devices: Dependent on validity of the Free Sale Certificate
1. 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.
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, and the applicant is provided with a reference number and receipt;
5. A regulator verifies the documents, if all the submissions are correct and fulfils the required criteria, a letter for importation of general medical devices will be printed out on copies at the back 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.
1. 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.
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, and the applicant is provided with a reference number and receipt;
5. A regulator verifies the documents, if all the submissions are correct and fulfils the required criteria, a letter for importation of general medical devices will be printed out on copies at the back 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.
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