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License Types and Permitted Activities

Manufacturers with a Manufacturer License can engage in manufacturing medical devices and distributing only the devices they manufacture. Their license fee remains unchanged at RM 4000 for new applications and RM 2000 for renewals.

The permitted activities are: - Manufacturer License: Manufacturing and distribution of medical devices (only for devices manufactured by them) - Authorized Representative (AR) License: Registering medical devices - Authorized Importer License: Importing registered medical devices - Distributor License: Distributing registered medical devices

The permitted activities are:
- Manufacturer License: Manufacturing and
distribution of medical devices (only for devices
manufactured by them)
- Authorized Representative (AR) License:
Registering medical devices
- Authorized Importer License: Importing registered
medical devices
- Distributor License: Distributing registered medical
devices

Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

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  • Kemaskini Terakhir: 20 November 2025.

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