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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.
The following three criteria must be met to be considered a reportable Adverse Event (AE):
All Adverse Events (AEs) should be reported immediately and;
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.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Malaysia@asiaactual.com
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