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.