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:
  1. Breast implants can only be sold to hospitals, medical institutes or licensed sales representatives.
  2. The implants must comply with ISO 14607:2018 (Non-Active Surgical Implants – Mammary Implants)
  3. Importers must keep patient records for 10 years and report every 6 months to the Thai FDA (details below).
  4. Additional labeling requirements (details below).
SPECIAL PATIENT INFORMATION RECORDING REQUIREMENTS FOR BREAST IMPLANTS INCLUDE:
  1. Name, address, contact number and Doctor’s medical certificate number
  2. Product name of implanted silicone breast prosthesis
  3. Type, model or product code
  4. Manufacturer Number / Lot Number
  5. Serial Number
  6. Import License Number
  7. Name, address, contact number of manufacturer, importer, seller.
  8. Patient information such as hospital ID (no direct reference to patients)
  9. Manufactured date
SPECIAL LABELING REQUIREMENTS FOR BREAST IMPLANTS (IN THAI AND ENGLISH) INCLUDE:
  1. Type of implanted silicone breast prosthesis with skin material
  2. Product dimensions
  3. Name, address, contract number of manufacturer, importer
  4. Assembly Detail (packing volume)
  5. Manufacturer Number / Lot Number
  6. Expiration Date (year must be 4 digits)
  7. Serial Number
  8. Import License Number
  9. Intended Use
  10. Instruction for Use and Storage Method
  11. 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 M