KUWAIT
KUWAIT
Medwisdom Lifescience offers end-to-end, MOH-compliant Regulatory Affairs services for Kuwait — including local scientific office support, eCTD submissions, Arabic labeling, pricing applications, medical device registration, and full lifecycle management.
Overview
Regulatory Affairs in Kuwait are managed by the Ministry of Health (MOH) through the Drug & Food Control Administration (DFCA) and Pharmacy & Drug Control Department. Kuwait is a full GCC member and accepts both the centralized GCC-DR procedure and direct national submissions.
Since 2023, all registrations are 100% electronic via the Kuwait MOH e-services portal in eCTD or NeeS format. Arabic labeling is mandatory, and pricing approval is required before final registration.
Registration Process for Drugs and Medical Devices
Two available routes:
- GCC Centralized Procedure (GCC-DR)
Single submission → approval valid across GCC (including Kuwait) - National Kuwait Procedure
Faster route for generics and products already registered in another GCC state - Medical Devices & IVDs
Risk-based classification; registration via MOH portal with CE/FDA clearance accepted. MDMA certificate valid for 5 years.
Tentative Registration Timelines (2025)
| Pathway / Product | Timeline |
|---|---|
| GCC-DR Centralized (New Drugs) | 12–18 months |
| GCC-DR Generics | 8–12 months |
| National Kuwait 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 / Variations | 3–6 months |
Challenges in Kuwait Regulatory Affairs
Applicants frequently encounter:
- Mandatory Kuwaiti local scientific office or agent
- Full Arabic labeling + patient leaflet required
- Pricing committee approval before final registration
- Zone IVB long-term stability data mandatory
- Legalisation of CPP, GMP, FSC certificates
- Portal technical updates and occasional downtime
Medwisdom resolves all these with our Kuwait City office, native Arabic team, and 100% first-time-right submission record.
Our Regulatory Affairs Services for Kuwait
- Local Scientific Office / Agent
MOH-registered Kuwaiti entity included - GCC-DR & National Submissions
eCTD/NeeS expertise - Arabic Labeling & Artwork
Native medical translation & mock-ups - Pricing Dossier & Committee Support
- Medical Device Registration
Full MDMA support - Cosmetics & Supplements Notification
- Variations, Renewals Transfers
- Regulatory Intelligence & GCC Updates
Why Choose Medwisdom for Kuwait Regulatory Affairs
- Kuwait City office with direct MOH relationships
- MOH-registered local scientific office — no third-party risk
- 15+ years of flawless GCC-DR and Kuwait national submissions
- Native Arabic medical translators for perfect labeling
- Expertise in both centralized and accelerated national routes
- Complete pricing approval support
- Real-time portal monitoring and immediate query handling
- Weekly client updates and transparent project tracking
Key Official Regulatory Resources – Kuwait
- MOH Kuwait – Drug Registration Portal
Electronic submissions & guidelines
eservices.moh.gov.kw - DFDC Drug & Food Control Administration
Registration procedures & forms
dfdc.moh.gov.kw - GCC Centralized Registration (GHAD)
Unified GCC-DR system
ghad.ae