Competent authority
authority.competent-authority
Ministry of Health — Drug Safety Center
Ministry of Health · structured requirements
🇴🇲 Oman medical device regulatory data
Explore the medical device requirements currently available for Oman, organized by topic and linked to official sources.
3 facts3 dimensions3 official sourceslatest verification 2026-08-13
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
Oman e-Health portal
- VerifiedHighlights
- The official service provides class-based fees, a 60-working-day service period and required-document categories.
- The Drug Safety Center separately publishes device, manufacturer, e-IFU, reporting, import and variation guidance/forms.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
WHO Prequalification of IVDs — collaborative abridged registration
reliance.reliance-edge-who-pq-ivd-to-crp43-program-who-pq-ivd-oman
- Target
geo:omn
- SourceApproval
WHO Prequalification of IVDs
- EdgeType
Collaborative Abridged Registration
- MarketAccessStrength
facilitated
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
Yes
- TargetDecisionRetained
Yes
- TimeTargetDays
90
- TimeBasis
Working Days After Access To All Relevant Information
Conditions
- WHO-prequalified IVDs
- manufacturer opt-in and consent
- participating NRA
- same product in all essential features
- national requirements and fees remain
Need to apply Oman's requirements to a product?
Confirm the current Ministry of Health pathway, evidence, and local-role details for the actual device before filing.