Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Feb 13, 20221 min read

Malaysia's Medical Device Authority Guidance on Refurbished Medical Devices.

Malaysia's Medical Device Authority (MDA) has published guidelines to help manufacturers and authorized representatives submit...

Nov 7, 20211 min read

Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA

Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...

Sep 8, 20212 min read

Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has released guidance about the requirements and procedures of good...

Aug 25, 20211 min read

Malaysia release GUIDANCE on "FOREIGN GMP INSPECTION"- NPRA

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices...