Quality Management System (QMS) Requirements
The QMS obligation
All medical device dealer's licence holders in Singapore must establish, implement, and maintain a Quality Management System (QMS) appropriate to the type of dealing activities they perform and the risk class of devices they deal in.
This requirement is described on HSA's website:
hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices
ISO 13485 alignment
The QMS must be aligned to ISO 13485:2016 — the international standard for quality management systems in the medical device industry. ISO 13485 covers the full range of QMS elements including:
- Management responsibility and quality policy;
- Resource management (people, infrastructure, work environment);
- Product realisation (for manufacturers) or product procurement, storage, and distribution (for importers and wholesalers);
- Measurement, analysis, and improvement (complaints, CAPA, internal audit);
- Risk management integration (aligned to ISO 14971).
QMS scope
The QMS scope must cover all regulated activities performed under the licence. For importers and wholesalers, this typically includes:
- Supplier qualification;
- Incoming goods receipt and inspection;
- Storage conditions (temperature, humidity monitoring);
- Distribution record management;
- Complaint handling and adverse event reporting;
- FSCA procedures.
For manufacturers, the QMS scope extends to design and development, production, and sterilisation (where applicable).
QMS audit
Before a dealer's licence can be issued, an HSA-recognised Medical Device Auditor must assess the applicant's QMS and confirm it meets the applicable requirements. The audit report is submitted as part of the licence application. See Medical Device Auditors.