Single Licence Policy — MDA implementation deadline for establishment licences
Key Date
2026-12-31 — Single Licence Policy — MDA implementation deadline for establishment licences
Malaysia's Medical Device Authority (MDA) is implementing a Single Licence Policy that streamlines establishment licensing by consolidating what were previously separate licences for different activities into a single establishment licence covering all relevant device-related activities.
Affected establishments include importers, distributors, and manufacturers. The policy is intended to reduce administrative burden while maintaining regulatory oversight.
Key actions:
- Confirm with MDA or your Malaysia-based regulatory representative whether your current establishment licence is affected by the Single Licence Policy.
- If a new application or amendment is required, initiate it well in advance of the implementation deadline.
- Check MDA's official FAQ and guidance on the Single Licence Policy for the specific timeline applicable to your establishment type.
Verify the current implementation date and requirements directly with MDA, as timelines may have been updated since initial announcements.
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