Medical Device Product Registration and Approval in Thailand
MEDICAL DEVICE REGULATION IN THAILAND
Medical devices are regulated by the Medical Device Control Division (MDCO) from the Food and Drug Administration (FDA) in Thailand (also known as Thai FDA) whose mission is to regulate and monitor health products so as to meet quality and efficacy requirements. Medical devices are regulated under the Medical Device Act B.E. 2531 (A.D. 1988).
The approval process in Thailand for Class III general medical devices (lowest risk) is relatively fast and easy. Due to its simple registration process, the manufacturer should consider penetrating this market if the manufacturer is dealing with a Class III general medical device. Most of the medical devices in Thailand is a Class III general medical device (lowest risk), including drug-eluting coronary stent and catheter system.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN THAILAND
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.
Category I (Licence Medical Devices)
Manufacturer, importer and distributor must have their medical devices approved by the Thai FDA before importing/supplying products in Thailand. Medical devices belonging to this category are:
2. Examination gloves
3. Surgical gloves
4. Sterile Hypodermic Disposable Syringes
5. Sterile Insulin Disposable Syringes
6. HIV Test Kits for Diagnostic use
7. Contact Lens
The manufacturers and importers of HIV Test Kits for Diagnostic use must hold a quality control accreditation. Furthermore, distributor and seller of this product must obtain a HIV Test Kits for Diagnostic use licence for the premise.
Category II (Notification Medical Devices)
Manufacturers, importers and distributors must notify the Thai FDA about their medical device to before importing/supplying products in Thailand. Medical devices belonging to this category are:
1. Physical therapy products
2. Alcohol Detector
3. Implanted Silicone Breast Prosthesis
4. Breast enhancement
5. HIV test kit (for researching and studying) which not for registration
Category III (General Medical Devices)
Medical devices that do not fall into categories I and II can be classified under category III. An import license must be obtained from the Thai FDA before the device can be imported to, or sold in Thailand.
Although the risk classification is reverse categorized in Thailand, the amount of evidence needed to prove the safety and efficacy of the device would be proportionate to the risk of the device, just like most countries.
For Licence and Notification of medical device application, Thai FDA expects the dossier to be submitted in Common Submission Dossier Template (CSDT) format. Based on ARQon’s experience, the CSDT dossier must also be included with the country-specific requirements for the specific product in order to obtain faster product approval.
Furthermore, ARQon’s director has also helped the Thai FDA in the CSDT evaluation requirements for the licence medical device.
General medical device application is one of the easiest and fastest product registration processes compared to a lot of countries. The approval is relatively fast so long as the few documents and database are prepared in the right format for Thai FDA. Note that Free sale certificate is required in the submission, which means that the product must be approved in the country of the manufacturer before submission can be made to Thai FDA.
In Thailand, the product license holder must also be the same importer and distributor. ARQon can help companies to obtain product license and import products to Thailand.
Process with ThaiFDA
1. The applicant must prepare seven required documents (refer to the table 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, 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.
Example of Approval