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 …
NPRA Malaysia Announces Implementation of Pilot Project for Pharmaceutical Track and Trace for Vaccines
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has announced their plan to develop a Pharmaceutical Track & Trace system that …
NPRA Malaysia Updates Variation Guideline for Pharmaceutical Products
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the second edition of the variation guideline for pharmaceutical products in …
MDA Malaysia Publishes Guideline on Re-registration of Registered Medical Device
The Malaysian Medical Device Authority (MDA) has released the first edition of the guideline on the re-registration process for registered …
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