TFDA
To manufacture, import, and distribute medical devices in Thailand, producr must pre-register its product with the Thai Food and Drug Admission (TFDA) for permission. Medical device is classified as General Medical Device, Notified Medical Device, and Licensed Medical Device in Thailand.
- General Medical Devices : No separate license is required, but a certificate of Free Sale (CFS) issued by the government of the producing country must be submitted. Over 90% of medical devices are included in this category.
- Notified Medical Device : Information for product manual, instruction, specification, label, manufacturer, distributor, and Certificate of Free Sale (CFS) must be submitted.
- Licensed Medical Device : The permission for producing process, import, and sale of product is required, and CFS must be submitted as well.
1. Basis Regulation
Medical Device Act B.E. 2551 (2008) 34th Ministry of Public Health Announcement B.E. 2549 (2006
2. Applicable Item List
Condoms, Examination gloves, Surgical gloves, Sterile disposable syringes/insulin syringes, HIV test kit, Contact lens, Physical therapy products, Alcohol detectors, Silicone breast prosthesis implant, Equipments and instruments for breast enhancer
3. Testing
No product testing is complied.
4. Notice
- All imported medical devices should submit a Certificate of Free Sale (CFS).
- Some products considere to be risky to consumers should be accompanied by Certificate of Quality System such as GMP or ISO 13485 besides Certificate of Free Sale (CFS).
- Importers without proper CFS are subject to be arrested for 5 years or be fined for 500,000 at maximum in thailand currency.
- The Medical device license can only be applicable by Thailand importr, and importer should possess import license prior to medical dvice import license application.
- Foreign exporter cannot apply for import license. In general, local importer, agent, or distributor submit required documentation on behalf of foreign manufacturers and apply for registration or approval.
5. Required Documentations.
- 1st step : Medical Device Importer Registration
- Application for importer registration (Form Sor. Phor. 1 or Sor. Nor. 1)
- Application Documents (GMDN code required)
- 3 photos of business license holders
- A copy of the power of attorney and the ID of the authorized person
- Medical certificate of the authorized person (within a month)
- Corporate registration
- 2 copies of Medical device import / storage plan, location map, and place photography.
- Medical device Procedure Application.
- 2nd step : Import Certification of Medical Device
- Proof of CFS and Certificate of Quality System (2 copies each)
- Copy of business Registration Certification
- Copy of business Representative's ID card
- Catalog, label, CFS documents for product specification
- Importer Registration License
- A copy of medical device product name and item code with electronic DB.
