Maintaining and Amending a Licence
Obligation to notify HSA of changes
Licence holders must notify HSA when certain details covered by the dealer's licence change. Changes that typically require a licence amendment include:
- Changes to the device risk class scope of the licence (e.g. expanding from Class B to Class C devices);
- Changes to QMS certification status (e.g. a new or updated ISO 13485 certificate);
- Changes to site details (warehouse address, premises, storage conditions);
- Changes to the Person-in-Charge (PIC) or other key personnel named on the licence;
- Changes to the company name or structure (e.g. following a merger or acquisition).
Licence amendments are submitted through the SHARE portal:
hsa.gov.sg/medical-devices/dealers-licence/amend-licence
Ongoing QMS surveillance
After the initial licence is granted, the QMS is subject to ongoing surveillance by HSA-recognised auditors. Companies should ensure their QMS remains current and that surveillance audits are conducted as required.