Post-Market Surveillance Overview
What is Post-Market Surveillance?
Post-market surveillance (PMS) is the systematic process of collecting, recording, and analysing data on the quality, safety, and performance of a medical device after it has been placed on the market. PMS is a mandatory ongoing obligation under Act 737 for all registered medical devices.
PMS activities generate evidence that:
- The device continues to perform as intended
- The benefit-risk profile remains acceptable
- Any new risks are identified and managed
- Regulatory commitments (e.g. PMCF) are being fulfilled
Legal Basis
PMS obligations arise from:
- Act 737 — post-market obligations of manufacturers and LARs
- Medical Device Regulations 2012 — specific requirements for post-market activities
- MDA Administrative Guidance Notes on vigilance and PMS
Who is Responsible?
| Party | PMS Responsibility |
|---|---|
| Manufacturer | Primary responsibility for PMS system design and execution |
| LAR | Implements PMS in Malaysia; reports to MDA; feeds data back to manufacturer |
| Importer / Distributor | Reports complaints and incidents through the supply chain |
Types of PMS Activities
Reactive PMS (Vigilance)
Responding to information that comes in about the device:
- Adverse event / incident reports from users, patients, healthcare providers
- Complaints received from customers
- Reports from other regulatory authorities (signal detection)
- Field safety corrective actions from other markets
Proactive PMS
Actively seeking information about device performance:
- Literature surveillance — systematic searching for published data on device type
- Post-market clinical follow-up (PMCF) studies
- Registry participation
- User surveys and satisfaction data
- Analysis of sales and device-in-use data
PMS Plan
For Class B, C, and D devices, manufacturers must maintain a written PMS plan that includes:
- Scope of the PMS system (device and indication covered)
- Methods for data collection (reactive and proactive sources)
- Frequency of data review and analysis
- Threshold criteria triggering action or reporting
- Responsibilities for PMS activities
- Integration with the risk management system
PMS Reporting
PMS data feeds into:
- Mandatory Problem Reports (MPR) to MDA for serious incidents
- Periodic Safety Update Reports (PSUR) submitted at registration renewal (and sometimes more frequently for Class D)
- Field Safety Corrective Actions (FSCA) when a safety issue is identified
- The risk management file (ongoing risk-benefit analysis)
Minimum PMS Data Sources for Malaysia
All registered device manufacturers/LARs should monitor:
| Source | Frequency |
|---|---|
| Malaysian complaint and adverse event reports | Continuous |
| MDA safety alerts and recalls (mda.gov.my) | Monthly check |
| Published medical literature on device type | Quarterly |
| Global regulatory authority alerts (FDA MAUDE, TGA, MHRA) | Monthly |
| Your own global PMS system outputs | Per your global PMS plan |
If you have a global PMS system (e.g. for US, EU, or Australian markets), ensure it captures Malaysian-specific data and that Malaysian adverse events are reported to MDA within Malaysian timelines — which may differ from other markets.