Mandatory Problem Reporting (MPR)

Overview

Mandatory Problem Reporting (MPR) is Malaysia's mechanism under Act 737 for reporting adverse events and device problems to MDA. It covers both manufacturers/LARs and — uniquely — also places obligations on healthcare professionals and facilities who become aware of device problems.

Who Must Report Under MPR?

Party	Obligation
Manufacturer / LAR	Must report serious adverse events and near-misses involving registered devices
Importer	Must report if first aware of an adverse event
Distributor	Must report if first aware of an adverse event; must forward reports up the supply chain
Healthcare professionals	Healthcare professionals who become aware of a serious adverse event may be required to report
Healthcare facilities	Hospitals and clinics are encouraged (and in some circumstances required) to report device problems

This broad scope means MDA may receive reports from multiple parties about the same event. Each party must report independently and not rely on another party to report on their behalf.

What Must Be Reported?

MPR applies to:

1. Serious adverse events — device-related events causing or contributing to death or serious injury
2. Near-serious incidents — events that could have caused death or serious injury but did not (near-misses)
3. Device malfunctions — if the device malfunction could lead to serious harm if it recurs
4. Systematic quality problems — where a pattern of events suggests a systemic quality issue

Reporting Timelines Under MPR

Event Type	Reporting Deadline
Death or immediately life-threatening event	2 working days
Serious injury	10 working days
Near-serious incident or malfunction (without immediate risk)	30 working days
Follow-up / final report	Within 30 days of investigation completion

Timelines run from the date the manufacturer, LAR, importer, or distributor first becomes aware of the event.

MPR Reporting Process

All MPR reports are submitted via the MyMDA portal:

1. Navigate to Post-Market → Mandatory Problem Report
2. Complete the MPR form:
   • Section 1: Reporter identification (company, licence number, contact)
   • Section 2: Device details (DRN, device name, model, lot/serial number, manufacturing date, expiry)
   • Section 3: Incident description (date, location, event description, patient outcome)
   • Section 4: Investigation summary (preliminary/final)
   • Section 5: Actions taken (immediate corrective actions)
3. Submit the report and retain the MDA acknowledgement

Correction, Updating, and Final Reports

• Initial reports should be submitted promptly, even if the investigation is not complete
• Follow-up reports update MDA as new investigation findings are available
• Final reports close the event with the complete root cause analysis and CAPA summary
• MDA must be notified of final report submission within 30 days of investigation completion

MPR Documentation and Retention

All MPR-related documentation must be retained for a minimum of 5 years:

• Initial, follow-up, and final report copies
• Investigation files and root cause analysis
• CAPA records
• MDA correspondence

Consequences of Failure to Report

Failure to submit required MPR reports is an offence under Act 737 and may result in:

• Financial penalties
• Suspension or cancellation of the establishment licence
• Suspension or cancellation of device registration
• Criminal prosecution

Report Early, Update Later

Submit your initial report on time even if investigations are incomplete. MDA understands that root cause investigations take time. It is the delay in the initial report that constitutes non-compliance, not submitting an initial report before the investigation is complete.