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FDAnews Device Daily Bulletin

Malaysian Government Updates Requirements for Exempt Devices

July 28, 2017

Malaysia’s Medical Device Authority updated its requirements for medical devices exempt from registration and is requiring notifications for demonstration models for marketing or education, models built for clinical research or performance evaluations, and custom-made or special access devices.

Importers or manufacturers of these devices are exempted from the requirement of an establishment license, but they must notify the agency using specific forms for each category of exempt product.

Notifications also are required for any changes in clinical trials, serious adverse events, progress reports on investigational devices, or export or disposal of devices upon completion of a clinical investigation.

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