OMAN
OMAN
Medwisdom Lifescience provides complete, MOH-compliant Regulatory Affairs services for Oman — including local agent support, GCC-DR submissions, eCTD/NeeS dossiers, pricing applications, medical device registration, and full lifecycle management.
Overview
Regulatory Affairs in Oman are governed by the Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC), Ministry of Health (MOH). Oman is a full member of the Gulf Cooperation Council (GCC) and participates in the centralized GCC-DR (Drug Registration) procedure while also accepting national submissions.
Since 2022, Oman has fully transitioned to fully electronic submissions via the GCC unified portal and its own e-services platform. All products follow the GCC Common Technical Document (CTD) format.
Registration Process for Drugs and Medical Devices
Two pathways available:
- Centralized GCC-DR Procedure
Single submission → approval valid in all 7 GCC states (including Oman). Preferred route for most innovative products. - National Oman Procedure
Direct submission to MOH Oman — faster for generics and products already registered in other GCC countries. - Medical Devices
Risk-based classification (I–IV). Registration via MOH portal with technical file and CE/FDA clearance. MDMA certificate valid for 5 years.
Tentative Registration Timelines (2025)
| Pathway / Product | Timeline |
|---|---|
| GCC-DR Centralized (New Drugs) | 12–18 months |
| GCC-DR Generics / Variations | 8–12 months |
| National Oman Route (with GCC reference) | 4–8 months |
| Medical Devices (Low–Medium Risk) | 3–6 months |
| Medical Devices (High Risk) | 6–12 months |
| Cosmetics Notification | 1–2 months |
| Renewals | 3–6 months |
Challenges in Oman Regulatory Affairs
Common obstacles include:
- Mandatory appointment of Omani local agent / scientific office
- Arabic labeling & package inserts required
- Pricing approval needed before final registration
- Strict stability data requirements for Zone IVB climate
- Frequent GCC portal technical updates causing submission delays
- Need for legalised documents (CPP, GMP, FSC)
Medwisdom eliminates these with our Muscat-based team, native Arabic translators, and perfect GCC portal track record.
Our Regulatory Affairs Services for Oman
- Local Agent / Scientific Office
MOH-registered Omani partner included - GCC-DR & National Submissions
eCTD/NeeS dossiers, GCC portal expertise - Arabic Labeling & Artwork
Native medical translation & mock-ups - Pricing Applications
Full pricing dossier & MOH coordination
- Medical Device MDMA Registration
Technical file & classification support - Cosmetics & Supplements Notification
- Variations, Renewals, Transfers
- Regulatory Intelligence & GCC Updates
Why Choose Medwisdom for Oman Regulatory Affairs
- Muscat-based team with direct MOH relationships
- Registered Omani local agent — no third-party needed
- 15+ years of flawless GCC-DR and Oman national submissions
- Native Arabic medical & regulatory translators
- Expertise in both centralized and fast national pathways
- Full pricing approval support — critical for final registration
- Real-time GCC portal monitoring & updates
- Transparent project tracking with weekly reports
Key Official Regulatory Resources – Oman
- MOH Oman – Drug Registration Portal
GCC-DR & national submissions
moh.gov.om/en/drug - GCC Centralized Registration System
Unified GCC-DR portal
ghad.ae – GCC Portal - Oman Medical Device Registration Guidelines
Classification & MDMA requirements
Medical Devices Section