Dealer's Licence — Overview
What is a dealer's licence?
A dealer's licence is an authorisation issued by HSA permitting a specific company to engage in regulated dealing activities involving medical devices in Singapore. "Dealing" covers manufacturing, importing, and wholesaling.
The dealer's licence is one of the two parallel obligations in Singapore's dual obligation model. The other obligation is product registration. Both must be satisfied before medical devices can be lawfully supplied.
Three types of dealer's licence
| Licence type | Who needs it | Activity covered |
|---|---|---|
| Manufacturer's licence | Any company manufacturing medical devices in Singapore for supply | Manufacturing finished medical devices at a Singapore facility |
| Importer's licence | Any company bringing medical devices into Singapore from overseas for supply | Importing finished devices for sale or distribution in Singapore |
| Wholesaler's licence | Any company selling medical devices to other businesses in Singapore | Wholesaling (B2B supply) of devices to hospitals, clinics, retailers, other distributors |
A single company may hold more than one licence type if it performs multiple activities (e.g. an importer that also wholesales to other distributors would typically need both an importer's and a wholesaler's licence).
The Quality Management System requirement
All dealer's licence applicants must establish and maintain a Quality Management System (QMS) appropriate to their scope of activities, aligned to ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes).
The QMS must be assessed by an HSA-recognised Medical Device Auditor as part of the licence application process. The auditor conducts a QMS audit and reports their findings to both the company and HSA.
See QMS Requirements and Medical Device Auditors for details.
Good Distribution Practice
For importers and wholesalers, the QMS must include procedures that comply with Good Distribution Practice (GDP) requirements. GDP covers storage conditions, handling, transport, and distribution record-keeping for medical devices.
See GDP Requirements.
How to apply
Dealer's licence applications are submitted through the SHARE portal. The application process, required documents, and fees are described in Applying for a Licence.
Licence duration and renewal
Dealer's licences have a set validity period and must be renewed before expiry. Supplying medical devices under an expired licence is a non-compliance. See Renewing and Cancelling a Licence.