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.
EDE · structured requirements
🇦🇪 United Arab Emirates medical device regulatory data
Explore the medical device requirements currently available for United Arab Emirates, organized by topic and linked to official sources.
7 facts3 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
Expired authorization cannot support ordinary import/marketing.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Renewal or maintenance
authorization.renewal
Renewal grants another 5 years; use the dedicated service while authorization is active/eligible.
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
- Prior Approval Amendment Or Variation
- New Registration Or New Application
- Description
Minor variation is available only while authorization is valid or active renewal is in process.
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
- major changes outside the amendment service
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
UAE local medical warehouse/marketing office applicant and named local agent
- Required For Foreign
yes
- Registration Relation
Local Eligible Applicant Holds Or Manages Authorization
- Importer Relation
Import By Local Agent Named In MA
- Distributor Relation
Can Be Separate Licensed Channel
- Combination
Allowed Subject To Licences
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
Authorization Amendment Or New Application Not Fully Verified
- Fresh Registration
Route Dependent
- Minimum Handover
- new agency appointment
- old agency termination
- marketing authorization dossier
- import permit records
- complaints/vigilance/recalls
- Arabic/English labels
- inventory
- Notes
Specific local-agent transfer service was not confirmed; treat as a validation gap.
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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