Post-Market Surveillance Obligations
What is post-market surveillance?
Post-market surveillance (PMS) is the systematic process of collecting, recording, and analysing data on the safety and performance of a device after it has been placed on the market. The purpose is to detect any adverse trends early and to ensure the device continues to perform as intended throughout its marketed life.
PMS under Singapore's framework
While Singapore's HP(MD) Regulations 2010 do not mandate a specific PMS documentation format or timeline as detailed as the EU MDR, registrants are expected to maintain a documented, active PMS programme proportionate to the device risk class as part of their quality management system obligations. The PMS approach should be commensurate with the device classification and the identified post-market risks.
PMS activities typically include:
- Monitoring customer complaints and post-market feedback;
- Reviewing adverse event data (both reported to HSA and from international sources);
- Monitoring international safety signals from reference agencies and IMDRF;
- Conducting post-market clinical follow-up studies where clinically indicated;
- Reviewing published literature on device performance and safety;
- Analysing field failure and return data.
PMS and the QMS
For companies holding a dealer's licence in Singapore, the QMS (ISO 13485-aligned) must include procedures for post-market feedback and complaint handling. PMS data also feeds back into risk management and design improvement processes.