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Applying for a Dealer's Licence

Application via SHARE​

Dealer's licence applications are submitted through the SHARE portal:

hsa.gov.sg/medical-devices/dealers-licence/apply

Before you apply — key prerequisites​

Before submitting a dealer's licence application, ensure:

  1. QMS is established and documented — ISO 13485-aligned QMS procedures are in place for the scope of activities you intend to licence.
  2. QMS audit is completed — an HSA-recognised Medical Device Auditor has assessed your QMS and issued an audit report. See Medical Device Auditors.
  3. Premises are ready — HSA may inspect the premises (warehouse, manufacturing facility) as part of the licence assessment.
  4. Company is Singapore-registered — the company must be registered with ACRA.

What is required in the application​

The application typically requires:

  • Company registration details (UEN, ACRA registration);
  • Description of the regulated activities to be covered by the licence;
  • Details of the scope of devices (device classes);
  • QMS certification or audit report from an HSA-recognised auditor;
  • Details of the Person-in-Charge (PIC) responsible for regulatory compliance;
  • Site/premises details (address, storage conditions, etc.);
  • For importers and wholesalers: evidence of GDP compliance.

Assessment process​

HSA reviews the application and may conduct a site inspection or request additional information. Upon satisfactory assessment, HSA issues the dealer's licence with specified conditions.

Fees and turnaround time​

Current fees and turnaround times for dealer's licence applications are published at:

hsa.gov.sg/medical-devices/fees

Official sources​