Post-Market Overview
Ongoing obligations after registration
Obtaining product registration and a dealer's licence is the beginning — not the end — of regulatory compliance in Singapore. Both the registrant and licensed dealers have ongoing post-market obligations under the Health Products Act and HP(MD) Regulations 2010.
Summary of post-market obligations
| Obligation | Who it applies to | Key reference |
|---|---|---|
| Adverse event reporting | All dealers (manufacturers, importers, wholesalers) and registrants | Adverse Event Reporting |
| FSCA reporting and action | Registrants and dealers | FSCA — When to Report |
| Change notification | Registrants | Change Notification |
| Post-market surveillance | Registrants (and manufacturers) | PMS Obligations |
| Distribution records | All licensed dealers | Distribution Records |
| Labelling compliance | Registrants and dealers | Labelling Requirements |
| Advertising compliance | Anyone advertising a medical device | Advertising Rules |
| Dealer's licence renewal | Licensed dealers | Renewing a Licence |
The post-market feedback loop
Post-market obligations are not merely administrative — they are designed to feed safety information back to HSA and to manufacturers, enabling:
- Early identification of device-related safety signals;
- Rapid communication of field safety issues to healthcare professionals and patients;
- Continuous improvement of device design and manufacturing;
- Evidence generation for post-market surveillance reports and clinical evidence updates.
A robust post-market system is both a regulatory requirement and good clinical risk management practice.
HSA's post-market monitoring activities
HSA conducts active post-market monitoring, including:
- Review of adverse event reports submitted by dealers and registrants;
- Monitoring of international safety signals from reference agencies (TGA, FDA, MHLW, etc.) and IMDRF;
- Market surveillance activities (inspections, sampling, testing);
- Publication of risk communications when devices are subject to FSCA.