Who Needs a Dealer's Licence?
The trigger — regulated dealing
A dealer's licence is required before engaging in any of the following regulated activities in Singapore:
| Activity | Licence needed |
|---|---|
| Manufacturing medical devices in Singapore | Manufacturer's licence |
| Importing medical devices into Singapore for supply | Importer's licence |
| Wholesaling medical devices (selling to another business) in Singapore | Wholesaler's licence |
Retail sale directly to the end user (e.g. a pharmacy selling devices to patients) is not a dealer's licence activity under the HP(MD) Regulations — but the pharmacy must ensure they only supply registered devices.
Who does NOT need a dealer's licence
- Overseas manufacturers supplying devices to a Singapore importer — the Singapore importer holds the licence, not the overseas manufacturer.
- Healthcare institutions (hospitals, clinics) that use medical devices on patients — they need to ensure devices are registered, but do not hold a dealer's licence for device use.
- Retailers selling registered Class A or other registered devices directly to consumers — retail supply is not covered by the dealer's licence requirement (though they may have other obligations under the HPA).
- Logistics and freight providers who merely transport devices without ownership or supply activity.
Multiple licence types
A single company often performs multiple activities and may need more than one licence type. Common combinations:
- A Singapore subsidiary of an overseas manufacturer that imports devices and also wholesales them to hospital distributors needs both an importer's and a wholesaler's licence.
- A contract manufacturer in Singapore making devices for export typically needs a manufacturer's licence.
- A trading company that imports devices for its own hospital group's use needs an importer's licence; if it then on-sells to other hospitals, it also needs a wholesaler's licence.
The HSA requirements tool
Use HSA's interactive tool to determine the licence type(s) needed for a specific activity:
hsa.gov.sg/medical-devices/registration/requirements