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.
- Implanted 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: 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.