Malaysia NPRA Publishes Screening Package for New Drug Products and Biologics
To enhance the submission process, Malaysia NPRA has developed a screening package for New Drug Products and Biologics to provide …
Malaysia Medical Device Authority (MDA) announces two key changes to the Product Classification Letter process.
1. Fully Online Application Process In line with its digital transformation efforts, MDA will fully transition to online submissions for …
Malaysia NPRA Updates Requirement of Safety Reporting in Clinical Trial Effective 30 April 2025
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has updated the clinical trial safety reporting requirements in the recently published …
Malaysia NPRA Updates Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX)
Malaysia NPRA has revised the Malaysian Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) …
Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device
MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the …
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can …
Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023. This guidance …
Malaysia MDA Implement Guideline On How To Submit An Application For Registration Of A Refurbished Medical Device
Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), …
MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN
The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations …
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