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Periodic Safety Update Reports (PSUR)

What is a PSUR?​

A Periodic Safety Update Report (PSUR) is a structured document that summarises the post-market safety experience of a registered medical device over a defined period. It provides MDA with a periodic overview of the device's benefit-risk profile based on accumulated post-market data.

The PSUR concept is aligned with IMDRF MDCE WG/N56 guidance on post-market clinical follow-up and the EU MDR PSUR framework.

Who Must Submit a PSUR?​

Device ClassPSUR Requirement
Class ANot routinely required; PMS summary at renewal
Class BPMS summary at 5-year renewal
Class CPSUR — annually or at registration renewal
Class DPSUR — annually (or more frequently if MDA requires)

MDA may require more frequent PSURs for any device class if safety concerns arise.

PSUR Content​

A comprehensive PSUR should include:

1. Device and Registration Information​

  • Device name, DRN, class
  • Registration date and current registration status
  • Scope of the PSUR (device types, indications covered)
  • Period covered by the PSUR

2. Post-Market Surveillance Data Summary​

  • Units sold/distributed in Malaysia and globally during the period
  • Summary of PMS activities conducted
  • Literature surveillance results
  • Registry data (if applicable)

3. Adverse Event and Complaint Summary​

  • Number and type of adverse events reported to MDA
  • Complaint trends
  • Comparison to previous period
  • Any unexpected findings

4. Field Safety Corrective Actions​

  • Summary of any FSCAs initiated during the period
  • Status of each FSCA

5. Post-Market Clinical Follow-Up (Class C and D)​

  • PMCF activities conducted during the period
  • Key PMCF findings
  • Assessment of whether PMCF plan objectives are being met

6. Benefit-Risk Assessment​

  • Updated benefit-risk analysis based on accumulated data
  • Conclusion: Is the benefit-risk profile still acceptable?
  • Any changes to risk assessment since last PSUR

7. Conclusions and Actions​

  • Overall safety conclusion
  • Any planned changes to the device, labelling, or IFU
  • Planned PMCF activities for the next period
  • Any signals requiring further investigation

PSUR Submission​

PSURs are submitted via the MyMDA portal under the Post-Market section. For Class D devices requiring annual submission, the PSUR must be submitted within 60 days of the end of the reporting period.

PSUR at Registration Renewal​

The PSUR (or equivalent PMS summary for Class A/B) is a required component of the registration renewal dossier. A well-prepared PSUR that demonstrates continued safety and effectiveness can streamline the renewal review.

Use Global PSUR as Foundation

If your organisation prepares PSURs for the EU (MDR Article 86) or other markets, use this as the foundation for the Malaysian PSUR. Add Malaysian-specific data (adverse events reported to MDA, Malaysian sales data, FSCA status in Malaysia) as a Malaysia-specific annex.