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Compliance and Transition

The single authorization, the single license policy will be fully implemented starting from July 1, 2024, and it will continue until the end of 2027 (until all of the establishments have converted their multiple-role licenses into single-role licenses).
They will have to separate the license that corresponds to the activities that they intend to conduct during renewal (Authorized representative, importer, distributor).

Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

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Medical Device Act 2012 (English) Lawatan Regulatori ke UAE - Mei 2025 Maklumat CIO KKM HRMIS MeDC@St 2.0

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  • Last Updated: 20 February 2026.

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