Adverse Event Reporting

Overview

The vigilance system in Malaysia requires manufacturers and LARs to report serious adverse events and near-serious events involving medical devices to MDA. This system is based on the GHTF SG2 Post-Market Surveillance guidance and is a core element of post-market obligations under Act 737.

What Must Be Reported?

Reportable Events (Mandatory)

An adverse event must be reported to MDA when a medical device has or could have contributed to:

Event Type	Description
Death	The device has or could have caused or contributed to a patient, user, or third party death
Serious injury	Serious deterioration in health — life-threatening illness, permanent impairment, hospitalisation, or intervention to prevent permanent impairment
Serious public health threat	Event that could affect a large number of patients or represents a serious public health concern

The "could have" element is important — near-miss events where a device malfunction could have caused serious harm, but did not due to intervention or chance, are reportable.

Common Reportable Scenarios

• Device failure causing or contributing to patient injury
• Unintended electrical shock from a device
• Unexpected loss of function of a life-sustaining device
• Contamination of a sterile device found in-use
• Software malfunction leading to incorrect diagnosis or treatment
• Labelling errors causing medication or dosage errors

Non-Reportable Events

• Device malfunctions that do not cause harm and could not have caused serious harm
• Expected side effects that are disclosed in the IFU and accepted in the benefit-risk assessment
• Product complaints without a safety element

Reporting Timelines

Event Severity	Report Type	Timeline
Death or serious injury — immediate threat	Initial Report	Within 2 working days
Death or serious injury — not immediate	Initial Report	Within 10 working days
Near-serious event	Initial Report	Within 30 working days
All reported events	Follow-up / Final Report	As investigation progresses; final within 30 days of investigation completion

Two-Day Reports

Events involving an immediate and serious public health threat must be reported to MDA within 2 working days of the manufacturer or LAR becoming aware. This is a very short timeframe — ensure your vigilance procedures are set up for rapid response.

How to Report

All adverse event reports are submitted via the MyMDA portal:

1. Log into MyMDA
2. Navigate to Post-Market → Adverse Event Report
3. Complete the adverse event report form:
   • Device details (DRN, model, lot/batch number)
   • Event description
   • Patient/user information (anonymised)
   • Investigation findings (initial or final)
   • Corrective actions taken
4. Submit report

MDA will acknowledge receipt and may request further information.

Report Contents

Initial Report (submitted within 2/10/30 days)

• Device identification
• Event description and date
• Patient/user information (anonymised)
• Preliminary assessment of cause
• Immediate corrective actions taken or planned

Follow-Up Report

• Updated investigation findings
• Root cause analysis progress

Final Report

• Complete root cause analysis
• CAPA description
• Effectiveness checks
• Summary conclusion on device involvement

Record Keeping

All adverse event reports, investigation files, and MDA correspondence must be retained for at least 5 years from the date of the report or the date of the last device manufactured, whichever is later.

Reporting of International Events

If an adverse event occurs in another country involving a device registered in Malaysia (bearing a Malaysian DRN), the manufacturer or LAR must assess whether the event is reportable under Malaysian timelines and report it to MDA if it meets the reportable criteria, even if it has already been reported to another regulator.