Mandatory Problem Reporting
What is the Mandatory Problem Reporting?
Mandatory problem reporting is also referred to as adverse event reporting in the ASEAN Medical Device Directive (AMDD).
According to Section 40 of the Act 737, the Authority shall be reported of any incident related to medical device that comes to the establishment’s attention, whether it occurs inside or outside of Malaysia.
The Medical Device Regulations 2019 define an incident as: an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of any person who used a medical device or any person associated with the use of the medical device.
Establishments is a tendency to report when there is doubt about the reportability of an incident. Any incident that meets the three basic reporting criteria listed below is considered reportable. These criteria are;
- that an incident has occurred;
- the medical device is associated with the incident;
- the incident led to one of the following outcomes: serious deterioration in state of health, death of a patient, user, or other person, a serious threat to public health, or no death or serious injury.
There are several conditions where reporting is not required under the vigilance system for medical devices. For further information, kindly refer to the guidance document. MDA/GD/0014 Mandatory Problem Reporting.
Incident Reporting Timeline
An establishment shall report any incident that is related to the failure of a medical device or a deterioration in its effectiveness, or has led to the death or serious deterioration in the state of health of a patient, user or other person.
An initial report shall be made within thirty days of the discovery, ten days from the discovery, or forty-eight hours from the discovery.
An investigation report shall be submitted to the Authority within 30 days after the submission of an initial report. The Authority may grant an extension time to the establishment if requested.
How to report Mandatory Problem Reporting (MPR)?
MPR can be reported online via the Medical Device Centralized Reporting System, MeDCReSt
MPR for combination products must be done manually by emailing and using the MPR Form: PART 1 & PART 2
Updated : 20th February 2023