Post Market Surveillance is required for manufacturers selling medical devices in Malaysia and failure to comply could lead to a product recall and/or loss of market access. Post Market Surveillance in Malaysia consists of reporting adverse events along with taking corrective actions if needed.
The Malaysia Medical Device Authority (MDA) implemented the Medical Device (Duties and Obligations of Establishment) Regulations 2019 this summer, incorporating guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.
The new Regulations are similar to the ASEAN Medical Device Directive’s (AMDD) guidance.
Reportable Adverse Events
The following three criteria must be met to be considered a reportable Adverse Event (AE):
An AE has occurred,
The medical device is associated with the AE,
The AE led to one of the following outcomes:
Serious threat to public health,
Death of a patient, user or other person,
Serious deterioration in state of health, user or other person,
No death or serious injury but the event might lead to death or serious injury of a patient, user or other person if the event recurs.
All Adverse Events (AEs) should be reported immediately and;
Not later than 48 hours for events that represent a serious threat to public health
Not later than 10 days for events that led to death or serious deterioration in state of health,
Not later than 30 days for events where a recurrence of which might lead to death or serious deterioration in state of health.
It is the responsibility of the Malaysia Authorized Representative listed on a product’s registration certificate to communicate with the Ministry of Health for all post-market vigilance issued on behalf of the legal manufacturer.
More information on Malaysia’s Post Market Surveillance can be found here.
Contact Asia Actual with questions regarding Malaysia Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.