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Reply to Malaysia is now a MDSAP member
portal.mda.gov.my
MALAYSIA IS NOW A MEMBER OF MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)
Official portal of MDA Malaysia. Regulatory information, device registration & safety under Medical Device Acts 737 & 738
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Malaysia is now a MDSAP member
Malaysia is now a MDSAP member – unable to post the link to the MDSAP site
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QMSR Transition: Medical Device File vs. DMR/DHF
With FDA’s new QMSR aligning to ISO 13485, one big question is terminology. ISO uses Medical Device File (MDF), while the old QSR terms Device Master Record (DMR) and Design History File (DHF) are still deeply rooted. Curious to hear how others are planning their QMS updates and what you think auditors and regulators will expect. Do you see the…
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