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 prescribe a specific PMS format as detailed as the EU MDR (which requires formal PSUR or PMS plan documents for specific classes), registrants and manufacturers are expected to maintain an active PMS programme as part of their quality management system obligations.
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.