This group of medical device composes of

  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

All manufacturers and importers of devices mentioned above must obtain a product Notification by the Thai food and Drug administration before manufacturing or importation.

Application for notification in manufacturing / importing medical devices Document Required

  1. Application to manufacture or import Medical Devices (Jor.Por.1)
  2. Attached Document

Two copy of document notification medical device

  1. Applicant letter
  2. Application form Jor.Por.1
  3. Index list 1 – 13
  4. Characteristics of medical Devices
  5. Packaging
  6. Type and quantity components
  7. Intended use, warning, precaution
  8. Instruction for use
  9. Storage
  10. Test report
  11. Certificate of Freesale
  12. Photo copy of trade or commercial registration copy of census , copy of ID card
  13. Map and plan of the manufacturers / Importers photograph of manufacture / Import location
  14. User manual
  15. Photocopy of establishment license

Source : http://www.fda.moph.go.th/fda-net/html/product/mdcd/eng/file_pdf/Notification%20Medical%20devices.pdf