Authorization duration
authorization.duration
- Type
Fixed Term
- Description
MDMA is valid for up to 3 years.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
SFDA · structured requirements
🇸🇦 Saudi Arabia medical device regulatory data
Explore the medical device requirements currently available for Saudi Arabia, organized by topic and linked to official sources.
5 facts3 dimensions2 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 MDMA cannot support ordinary placement.
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
Material changes are updated within 10 days and non-material changes within 30 days under the implementing regulation; exact prior-approval effects depend on change category.
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
Manufacturer Mandated Authorized Representative
- Name
Saudi Authorized Representative
- Required For Foreign
yes
- Registration Relation
Local Authorized Representative For Manufacturer And MDMA Services
- Importer Relation
Distinct Licensed Role
- Distributor Relation
Distinct Licensed Role
- Combination
Possible Only With Each Required Licence
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
GHAD MDMA Transfer
- Fresh Registration
No If Transfer Approved
- Minimum Handover
- new AR authorization
- old AR termination
- MDMA transfer request
- dossier
- vigilance/complaints/recalls
- Arabic/English labels
- importer/distributor links
- Notes
SFDA provides an explicit online transfer service.
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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