Seller of Medical Devices
21 May 2023

Seller of Medical Devices 


“sell” means an act of distributing, supplying, giving, exchanging, lending, granting a lease, granting a lease on a hire-purchase basis or transferring rights or possession to another person, for the purpose of trade, and shall also include an act of having in possession for sale


Any person who wishes to sell medical devices as stated below shall submit an application for permission and may sell such medical devices when the licensor has issued a licence therefor.

  1. Implanted 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: The manufacturer or importer who has permission to manufacture or import listed or notified or licensed medical devices shall be deemed to be the permission grantee for the sale of medical devices manufactured or imported by such manufacturer or importer without being required to submit an application for sale permission.