List of Medical Devices requiring a seller's license
Medical devices requiring a seller's license are listed below:
- Silicone breast implant
- Teeth Whitening Devices
- Ophthalmic Viscosurgical Device (OVD)
- HIV Test Kits (excluding HIV self-testing)
- Blood Bag
- Injectable Hyaluronic Acid Dermal Filler
- Dental Medical Devices (12 items) :
- Dental implants
- Orthodontic brackets or braces
- Orthodontic elastics
- Orthodontic wires
- Orthodontic bands
- Clear dental aligners
- Etching agents
- Dental filling materials
- Dental bonding agents or cementing agents (excluding denture adhesives)
- Impression materials for dental use
- Artificial teeth
- Fluoride varnish
8. Medical devices requiring a sale license with physician's prescription (1 item) :
- 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.