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June 16, 2025
Approximately 5 minutes
Post-Market Surveillance and Adverse Event Reporting in Malaysia: MDA Vigilance Requirements
Post-Market Surveillance and Adverse Event Reporting in Malaysia: MDA Vigilance Requirements
Post-Market Surveillance (PMS) is a mandatory requirement for all manufacturers selling medical devices in Malaysia. This vigilance system is enforced by the Medical Device Authority (MDA) under the Medical Device Act 2012 and the Medical Device (Duties and Obligations of Establishment) Regulations 2019. Failure to comply with these requirements, which are similar to those in the ASEAN Medical Device Directive (AMDD), can result in product recall or loss of market access.
The Role of the Authorized Representative
The Malaysia Authorized Representative (AR), or license holder, whose details are listed on the product's registration certificate, holds a critical responsibility in the PMS process. The AR is the legally responsible entity for communicating with the MDA on behalf of the foreign manufacturer regarding all post-market vigilance issues, including Adverse Event (AE) reporting and Field Safety Corrective Actions (FSCAs).
Criteria for Reportable Adverse Events (AEs)
An event is considered a reportable Adverse Event (AE) only if three core criteria are met:
- An Adverse Event has occurred.
- The medical device is associated with the Adverse Event.
- The Adverse Event led to one of the following serious outcomes:
- A serious threat to public health.
- Death or serious deterioration in the state of health of a patient, user, or other person.
- No death or serious injury occurred, but the event, if it recurs, might lead to death or serious injury of a patient, user, or other person.
Mandatory Reporting Timelines
All Adverse Events must be reported to the MDA immediately and within the following specific timeframes, calculated from the moment the manufacturer or their AR becomes aware of the event:
| Event Type | Reporting Deadline |
|---|---|
| Serious threat to public health | Not later than 48 hours |
| Death or serious deterioration in state of health | Not later than 10 days |
| Recurrence might lead to death or serious injury | Not later than 30 days |
Post-Market Corrective Actions (FSCAs)
In addition to reporting, manufacturers are obligated to implement Field Safety Corrective Actions (FSCAs) if necessary. The AR is responsible for managing the communication and implementation of these corrective actions in collaboration with the MDA to ensure device safety and compliance in the Malaysian market.
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