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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS
With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4) for all applications submitted from May 5, 2020. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.
Other stipulations were added to the regulatory requirements for breast implants, such as:
- Breast implants can only be sold to hospitals, medical institutes or licensed sales representatives.
- The implants must comply with ISO 14607:2018 (Non-Active Surgical Implants – Mammary Implants)
- Importers must keep patient records for 10 years and report every 6 months to the Thai FDA (details below).
- Additional labeling requirements (details below).
Special patient information recording requirements for breast implants include:
- Name, address, contact number and Doctor’s medical certificate number
- Product name of implanted silicone breast prosthesis
- Type, model or product code
- Manufacturer Number / Lot Number
- Serial Number
- Import License Number
- Name, address, contact number of manufacturer, importer, seller.
- Patient information such as hospital ID (no direct reference to patients)
- Manufactured date
Special labeling requirements (in Thai and English) include:
- Type of implanted silicone breast prosthesis with skin material
- Product dimensions
- Name, address, contract number of manufacturer, importer
- Assembly Detail (packing volume)
- Manufacturer Number / Lot Number
- Expiration Date (year must be 4 digits)
- Serial Number
- Import License Number
- Intended Use
- Instruction for Use and Storage Method
- Warnings (All need to be in Red-colored font)
- ‘Single Use’
- ‘Only for certified medical license holder use’
- For textured breast implants only – ‘Has a risk of breast implant associated with anaplastic large cell lymphoma (BIA-ALCL)’
Products covered by an existing Import License will retain market access until expiry. All new or renewal applications are subject to the new requirements.
Products considered Licensed (e.g., Class 4 breast implants) or Notified Medical Devices by the Thai FDA will then be required to undergo an Expert Review where the associated fees (listed below) are determined by the devices ASEAN classification.
Device Classification | Expert Review Fees |
---|---|
Class 1 | THB 25,000 (US $740) |
Class 2 | THB 38,000 (US $1,120) |
Class 3 | THB 63,000 (US $1,850) |
Class 4 | THB 88,000 (US $2,590) |
Additionally, all registration application are subject to Thai FDA processing fees depending on category (i.e., Licensed, Notified, General) as below.
Device Classification | Processing Time | Devices | Thai FDA Processing Fees |
---|---|---|---|
Licensed Medical Devices | 1 year | Condoms Gloves (surgical and exam) Syringes HIV test kits Contact lens (corrective and cosmetic) Injective Hyaluronic for defective skin Breast implants | THB 10,100 |
Notified Medical Devices | 6-8 months | Physical therapy equipment Alcohol detectors Methamphetamine detectors Breast implants Ophthalmic Viscoelastic Device Concentrate for haemodialysis Alcohol based sterilizer Alcohol gel sanitizer Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) Intense Pulsed Light (IPL) devices (pending) Automatic External Defibrillators (AED) (pending) Syphilis Screening Tests (pending) | THB 10,100 |
General Medical Devices | 2-6 days | All other medical devices Including dental equipment | THB 1,100 or THB 2,100 |
Contact Asia Actual to register medical devices in Thailand.