The Medical Device Authority (MDA) in Malaysia has released MDA/GD/0014, Guidance Document for Mandatory Problem Reporting which comes into operation starting on 1 July 2020. Previously, mandatory problem reporting was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.
In this newly released guidance document, MDA/GD/0014, Mandatory Problem Reporting, it states that every establishment shall report any incident involving its medical device which comes to the establishment’s attention whether occurring inside or outside of Malaysia to the Authority only if the medical device is registered in Malaysia. These problems can be reported by submitting Annex A, Mandatory Problem Reporting Form and Annex B, Investigation Form to the Authority.
The establishment shall investigate the cause of incident and conduct field corrective action if necessary, to prevent recurrence of the incident and to ensure safety and performance of the medical device. The Authority will evaluate the investigation report and if the report and action taken are satisfactory, the Authority will inform the establishment in writing to close the matter.
The requirement to submit a mandatory report shall not apply to any incident that occurs outside Malaysia if that incident has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has been taken by the manufacturer or establishment in the country where the incident occurred and on all the affected devices placed in the Malaysian market.
As soon as any personnel of the medical device manufacturers or its authorized representative, including sales personnel, are made aware of the incident, problems must be reported within specific time delays according to the severity of the problem:
- within 48 hours after the establishment becomes aware that the incident is a serious threat to public health;
- within 10 days after the establishment becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were the incident to recur; or
- within 30 days after the establishment becomes aware of an incident that is related to the failure of the medical device or a deterioration in its effectiveness, or any inadequacy in its labeling or in its instruction for use, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person.
However, there are some instances where the reporting is not required. For example:
- Deficiency of a device found by the user prior to its use
- Service life or shelf-life of the medical device has been exceeded
- Protection against a fault functioned correctly (a design feature protected against a fault becoming a hazard)
- Expected and foreseeable side effects
- Negligible likelihood of occurrence of death or serious deterioration in state of health
If you have any queries regarding the mandatory problem reporting for medical devices or our services for medical device registration and representation in Malaysia, please contact us at firstname.lastname@example.org.