Regulatory Blog

Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...

The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...

On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...

The Malaysian Medical Device Authority (MDA) drafted a guideline on personal protective equipment (PPE) and seeks feedback from the...

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

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

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

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