Authorization duration
authorization.duration
- Type
Fixed Term
- Description
5 years
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
MDA · structured requirements
🇲🇾 Malaysia medical device regulatory data
Explore the medical device requirements currently available for Malaysia, organized by topic and linked to official sources.
7 facts4 dimensions4 official sourceslatest verification 2026-08-13
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
Official document
Expiry or lapse consequence
authorization.lapse
After expiry, a new registration application is required.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Change-control outcomes
change.available-outcomes
- Outcomes
- Notification Or Administrative Update
- Prior Approval Amendment Or Variation
- New Registration Or New Application
- Description
Ownership/AR change is a defined transfer process, distinct from technical changes.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
New-application triggers
change.new-application-triggers
- expired certificate
- changes outside permitted change-notification scope
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Local market-entry role
market-entry.local-role
- Archetype
Marketing Authorization Holder Or Registrant
- Name
Malaysian Authorized Representative
- Required For Foreign
yes
- Registration Relation
Local Registration Holder
- Importer Relation
Separate Licensed Role Appointed By AR
- Distributor Relation
Separate Licensed Role Appointed By AR Or Manufacturer
- Combination
Separate Role Licences Required Even If Same Entity
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Representative or holder change
market-entry.representative-change
- Path Code
Change Ownership Or AR Transfer
- Fresh Registration
No If Transfer Approved
- Minimum Handover
- manufacturer appointment and old termination
- distribution and complaint records
- registration certificates
- post-market/vigilance records
- new AR relabelling
- stock transition
- Notes
Old stock must carry the new AR information before placement on the market.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Label, IFU & language
Which label and IFU elements, languages, symbols, and translation controls apply?
Label, IFU, and submission language
language.label-ifu-submission
- Label Ifu
Bahasa Malaysia for home-use devices; English permitted for other devices subject to current guidance
- Submission
English/Bahasa Malaysia according to MeDC@St requirements
- Status
Verified Current
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
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