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Malaysia: MDA, HSA, Forge Closer Ties with pilot Medical Device Regulatory Reliance Programme (1 Sept 2025 - 28 Feb 2026)
22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the...

ARQon
Aug 252 min read


Malaysia: Globally Leads with New Medical Device Regulatory Reliance Programme (effective from 30 July 2025)
In a world where healthcare innovation often outpaces regulations, one country is stepping forward to bridge that gap with confidence,...

ARQon
Jul 252 min read


Malaysia: MDA Bans Online Sales of Optical Devices and Contact Lenses
The Medical Device Authority (MDA) has released an official statement reinforcing a strict prohibition on the online sale of optical...

ARQon
Jun 182 min read


Malaysia: MDA Issues Advisory on Malaria Test Kit
The World Health Organization (WHO) released a notification regarding the performance of certain malaria diagnostic test kits , which has...

ARQon
May 271 min read


Malaysia: MDA Implements Medical Device Import Permit Requirement (transition w.e.f 14 April 2025)
In a move to enhance the regulation and traceability of medical device imports, the Medical Device Authority (MDA) has officially...

ARQon
May 52 min read


Malaysia: MDA Sets 2-Year Validity Period for Product Classification Letters (w.e.f 1 May 2025)
The Medical Device Authority (MDA) has announced a key regulatory update that impacts all stakeholders within the medical device and...

ARQon
Apr 171 min read


Malaysia: Transition to Online Product Classification Application Process by MDA (w.e.f. 1 May 2025)
Starting 1 May 2025 , the Medical Device Authority (MDA) is pleased to announce that all product classification applications must be...

ARQon
Apr 141 min read


Malaysia: MDA Releases First Edition Guidance on Importation of Medical Device for Re-Export (IRE)
To provide clarity and streamline compliance with the Medical Device Act 2012 (Act 737), on the 13 March 2025, the Medical Device...

ARQon
Mar 192 min read
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