How to Change Your Authorised Representative in Malaysia
Replacing an Authorised Representative in Malaysia is processed as a change of ownership of the device registration. Target turnaround is…
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Regulatory Intelligence
Insights
Market analysis, regulatory updates, and strategic perspectives on pharmaceutical and medical device access in Southeast Asia.
How to Transfer Your Malaysian MAL to a New Product Registration Holder
The application to move a Malaysian marketing authorisation to a new holder is filed by the company you want to…
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DRGD 12th Revision: What Changed for Product Registration Holders in Malaysia
C. Y. Chin, Business Development Director | Infinity Pharmacare | September 2026 Two new clauses in the Drug Registration Guidance…
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Independent Authorised Representative or Distributor: Who Controls Your Malaysian Device Registration
A foreign manufacturer cannot register a device in Malaysia in its own name. A local Authorised Representative becomes the registrant…
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NPRA Variation and Post-Approval Change: What Happens to Your MAL After Registration
A registered product's MAL is not a fixed asset. Every material change to it must run through NPRA's variation framework,…
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Malaysia Medical Device Classification and Registration Timelines: Class A to D Explained
Classification decides whether a Conformity Assessment Body sits between your device and MDA, and therefore whether your registration runs three…
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What Is a Product Registration Holder (PRH) in Malaysia and Why You Cannot Hold Your Own MAL
A foreign manufacturer cannot hold its own Malaysian MAL. It must appoint a locally incorporated Product Registration Holder (PRH). Here…
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MDA Establishment Licence Malaysia: What Foreign Manufacturers Need to Know Before Appointing a LAR
A foreign manufacturer cannot hold an MDA Establishment Licence directly in Malaysia. This briefing explains what the licence is, who…
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How Foreign Manufacturers Access Malaysia’s Public Sector Drug Market: APPL, Central Contract, and Local Purchase
Three routes into Malaysia's government drug market: APPL, Central Contract, Local Purchase. Why stable placement, not channel choice, drives price.
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