List of Medical Devices requiring a seller's license

Medical devices requiring a seller's license are listed below:

1. Silicone breast implant 
2. Teeth Whitening Devices 
3. Ophthalmic Viscosurgical Device (OVD) 
4. HIV Test Kits (excluding HIV self-testing)
5. Blood Bag
6. Injectable Hyaluronic Acid Dermal Filler
7. Dental Medical Devices (12 items) :
8. Dental implants
9. Orthodontic brackets or braces
10. Orthodontic elastics
11. Orthodontic wires
12. Orthodontic bands
13. Clear dental aligners
14. Etching agents
15. Dental filling materials
16. Dental bonding agents or cementing agents (excluding denture adhesives)
17. Impression materials for dental use
18. Artificial teeth
19. Fluoride varnish

8. Medical devices requiring a sale license with physician's prescription (1 item) :

1. Positive Airway Pressure (PAP) device.

Remark: Manufacturers or importers of listed, notified, or licensed medical devices are permitted to sell the devices they manufacture or import, without needing a separate sales license.

Quality Management System

The licensed seller must comply with the Ministry of Public Health Notification on the Quality Management System for Medical Device Import and Sale B.E. 2566. More information below.

Advertisement Approval

Anyone who wishes to advertise a medical device must obtain advertising approval.

Please click here for more information (in Thai)