Types of licences
An importer's licence allows the dealer to bring a medical device into Singapore.
Licensed importers require a Wholesaler's licence for wholesale supply.
A wholesaler's licence allows the dealer to:
- supply a medical device by wholesale (including export) in Singapore.
- supply a medical device to a party for re-supply.
- supply a medical device as a commercial sample.
However, a wholesaler's licence is not required for supply to end-users, such as in a retail store.
A manufacturer's licence allows the dealer to:
- Make, fabricate, produce or process a medical device.
- Package and label a medical device before it is supplied.
Licensed manufacturers do not require a Wholesaler's licence to supply medical devices which are manufactured under their Manufacturer's licence.
Import, supply and manufacture of drug of abuse test kits needs additional controlled drug licences under the Misuse of Drugs Act besides licences under Health Products (Medical Devices) Regulations. For more information on controlled drug licence application, please contact the Licensing and Certification Branch at Email: firstname.lastname@example.org.
You will need to upload supporting documents depending on the type of licence.
Fees and turn-around-time
Refer to medical device fees and turn-around-time for more information.
How to apply
You can apply for a dealer's licence using MEDICS.
Don't have a MEDICS account? Apply now through CRIS.
Withdraw a licence application
You may choose to withdraw an application while in progress, via MEDICS.