Post-Market Surveillance (PMS) for Medical Devices in Malaysia 2026

Updated for 2026: Reflects MDA/GD/0070 Second Edition (September 2025) standardising PMS data to the past 3 years, the Medical Device (Designated Medical Device) Order 2026 effective 1 June 2026 expanding the device scope, the Medical Device (Duties and Obligations of Establishments) Regulations 2019, and updated MDA guidance as of August 2026. Quick Answer Post-Market Surveillance …

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