MOH Medical Device Registration and Authorized Representative Oman
Enter Oman a fast growing Gulf healthcare market backed by Vision 2040 hospital investment and rising medtech demand. NexorTest delivers end-to-end MOH DGPA&DC market access: Class A-D listing and registration under Decree 113/2020, CSDT dossier preparation, the CE & FDA reliance pathway, Omani Authorized Representative services and Apostille legalization all under one expert roof.
Four Risk-Based Device Classes Under the MOH DGPA&DC
Oman applies the Oman follows a GHTF/IMDRF aligned risk based classification framework and may consider classifications assigned by recognized regulatory jurisdictions. Your class determines the depth of the CSDT dossier and the conformity evidence the Medical Device Control Department requires.
Class A Devices
Non-invasive devices, surgical instruments, hospital beds, examination gloves and patient scales. Mapped from EU Class I and low risk FDA categories.
- Listing First
- CE / FDA Reliance
- 5 Year Validity
Class B Devices
Short term invasive and low to moderate risk devices such as surgical masks, suction equipment and hypodermic needles. Maps to EU Class IIa.
- CSDT Dossier
- DoC Required
- ISO 13485
Class C Devices
Moderate to high risk devices such as infusion pumps, ventilators, X ray and imaging equipment and contact lenses. Maps to EU Class IIb and parts of Class III.
- Full CSDT
- Essential Principles
- FSC / CFG
Class D Devices
High risk Class III, Class IV and active implantable devices stents, heart valves, pacemakers and implantable defibrillators. The most rigorous review.
- Highest Scrutiny
- Full Dossier
- PMS Plan
Routes to Oman Market Access
Oman is transitioning from notification based listing to full risk based registration. NexorTest selects and manages the optimal pathway so you enter the market fast and stay compliant as the rules evolve.
Notification / Listing Pathway
The current mandatory step for market entry. Every device must be entered in the Medical Device Control Department database via the MOH eServices portal before it can be imported or sold. Leveraging an existing CE marking or US FDA clearance streamlines the file and gets you to market in roughly 3-4 months.
Registration Pathway
The fuller risk based market authorization being rolled out under Decree 113/2020 and the 2025 manufacturer-registration guidance. Requires a CSDT dossier with essential principles conformity, design verification and validation, and a Free Sale Certificate or Certificate of Foreign Government for US products.
Local Authorized Representative
Every foreign manufacturer must operate through an Omani Authorized Representative holding a Commercial Registration with approved medical device wholesale activity. NexorTest holds your authorization as an independent AR so you retain full control of your registrations.
End-to-End Oman Regulatory Consulting
From regulatory strategy and Authorized Representative appointment through CSDT documentation, MOH eServices submission and post-market compliance a complete one stop solution for the Omani market.
Authorized Representative
Independent Omani AR services, including Commercial Registration with medical device wholesale activity, manufacturer authorization letters and acting as your legal liaison with DGPA&DC.
Classification & Strategy
Accurate Class A/B/C/D determination mapped from your CE or FDA classification, with a listing first then registration roadmap and timeline forecast for Oman.
CSDT Documentation
Preparation and review of the Common Submission Dossier Template device description, essential principles, design verification and validation, labeling and the full registration file.
Listing & Notification
Compilation and submission of the official MOH listing Excel sheet to the Medical Device Control Department database for immediate, compliant market entry.
MOH eServices Submission
End-to-end management of the MOH eServices portal account setup, dossier upload, fee payment and application tracking through to authorization.
Apostille Legalization
Oman is an Apostille country we manage Apostille legalization of your CE, FDA, ISO 13485 and Free Sale certificates, plus certified Arabic/English translations.
Import License Support
Coordination of import licenses and clearance so your Authorized Representative can bring devices into Oman once listing or registration is granted.
IVD & SaMD Registration
Specialized support for In Vitro Diagnostics and Software as a Medical Device, covering performance evidence, software lifecycle and digital health documentation.
Post-Market Surveillance
Adverse event and field safety reporting, deficiency notice responses, change management and timely 5 year authorization renewals through your AR.
Why Manufacturers Choose Us for Oman
We hold your Oman authorization as Authorized Representative while leveraging your CE marking or FDA clearance to streamline listing and registration building registration grade CSDT dossiers that future proof your access as Decree 113/2020 is enforced.
Local AR + Global Strategy
A single partner that holds your Oman authorization as Authorized Representative while coordinating CE, US FDA, Saudi SFDA and wider GCC approvals across 50+ markets.
Reliance Pathway Specialists
We leverage your existing CE marking or FDA clearance to streamline Oman listing and registration, managing the Free Sale Certificate route when neither is available.
Transition Ready Filings
We list you for fast market entry today and build a registration grade CSDT so your Oman access is future proofed as Decree 113/2020 registration is enforced.
Transparent Fixed Fee Packages
Clear project based pricing from classification to authorization no surprise hourly charges, built for manufacturers, importers and start ups.
Six Steps to Your Oman Market Authorization
A proven, structured approach that maps your CE or FDA evidence to the Oman framework and gets you to market fast while future-proofing for full registration.
Appoint Authorized Representative
We act as your Omani AR with a Commercial Registration covering medical device wholesale activity, ready to submit to MOH DGPA&DC on your behalf.
Classification & Reliance Strategy
We confirm your Class A/B/C/D status from your CE or FDA file and define the listing first then registration strategy for Oman.
Dossier & Apostille
We assemble the CSDT, CE/FDA certificate, Declaration of Conformity, ISO 13485, Free Sale Certificate and labeling, with Apostille legalization.
MOH eServices Submission
We submit the listing Excel sheet and registration dossier through the MOH eServices portal and pay applicable fees.
Review & Query Management
We manage the DGPA&DC technical review, respond to deficiency notices and provide any samples or evidence requested.
Authorization & Post-Market
You receive your market authorization; we secure import licenses, set up vigilance reporting and manage renewals before the 5 year expiry.
Oman MOH Registration Document Checklist
The MOH DGPA&DC requires a complete, legalized dossier. Oman is one of the few MENA Apostille countries, so most certificates need only Apostille rather than full consular legalization.
| Document | Description & Guidance |
|---|---|
| CE Certificate or FDA Clearance Reliance | CE certificate (EU MDR/MDD) or US FDA clearance (510(k), De Novo or PMA) the primary evidence of approval from a recognized reference market that underpins Oman reliance. |
| Free Sale Certificate / CFG | Issued by the competent authority in the country of origin. For US manufactured products, a Certificate of Foreign Government (CFG) or CDNE is accepted, Apostille legalized. |
| Declaration of Conformity | Manufacturer's signed declaration confirming the device meets the essential principles and the requirements of the applicable EU directive or regulation. |
| ISO 13485 Certificate | Valid quality management system certificate covering the manufacturing site, current and issued by an accredited certification body. |
| CSDT Dossier Class B/C/D | Common Submission Dossier Template covering device description, essential principles, design verification and validation, labeling and post-market surveillance plan. |
| AR Authorization & CR | Manufacturer authorization letter appointing the Omani Authorized Representative, plus the AR's Commercial Registration showing approved medical device wholesale activity. |
| Labeling & IFU | Device labeling and Instructions for Use including the device identification number, manufacturer details and AR contact details; certified Arabic/English where required. |
| Risk Management File Class C/D | ISO 14971 risk-management documentation and clinical evidence for higher-risk devices, demonstrating benefit-risk acceptability. |
Oman Registration Across All Device Sectors
Our regulatory team supports manufacturers across the full spectrum of medical technology and IVD categories entering Oman and the wider GCC.
- 🏥 Cardiovascular Devices
- 🦴 Orthopedic Implants
- 🔬 In Vitro Diagnostics
- 💻 Software as Medical Device
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 📊 Imaging & Radiology
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
- 💡 AI/ML Medical Devices
Frequently Asked Questions for Medical Device Registration Oman
Who regulates medical devices in Oman?
The Ministry of Health (MOH) regulates medical devices in Oman through the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) and its Medical Device Control Department. The framework is enforced under Ministerial Decree 113/2020. Every device must be listed and increasingly registered before it can be imported, placed on the market or put into service in Oman.
Do I need an Authorized Representative in Oman?
Yes, Foreign manufacturers without a legal entity in Oman must appoint a local Omani Authorized Representative holding a Commercial Registration with approved medical device wholesale activity. The AR submits the listing and registration files, holds the authorization and is the DGPA&DC’s legal point of contact. NexorTest provides independent Authorized Representative services so you keep control of your registrations.
How are medical devices classified in Oman?
Oman uses the GHTF/IMDRF four class model: Class A (low risk), Class B (low moderate, ~EU IIa), Class C (moderate-high, EU IIb/III) and Class D (high risk, Class III/IV and active implantables). Oman accepts the classification of your country of origin jurisdiction but DGPA&DC may reclassify a device based on its own risk assessment, so classification should be confirmed before submission.
What is the difference between listing and registration?
Listing (notification) is the current mandatory step every device must be entered in the Medical Device Control Department database via the MOH eServices portal before import or sale. Registration is the fuller risk based authorization being rolled out under Decree 113/2020, requiring a CSDT dossier and conformity evidence. NexorTest manages both immediate listing for fast entry and registration to future proof your access.
How long does Oman registration take?
The listing/notification pathway typically takes around 3-4 months once the AR is appointed and the dossier is complete. Full CSDT-based registration for higher risk Class C and D devices generally runs 4-6 months. Having a CE marking or FDA clearance and a valid ISO 13485 certificate ready, and responding promptly to deficiency notices, keeps the review on track.
What documents are required for registration?
Core documents include a CE certificate or FDA clearance, a Free Sale Certificate or CFG, a Declaration of Conformity, a valid ISO 13485 certificate, a CSDT dossier for Class B/C/D, the AR authorization letter and Commercial Registration, and compliant labeling and IFU. Oman is an Apostille country, so certificates need only Apostille legalization rather than full consular legalization.
How long is an Oman authorization valid?
Market authorizations issued in Oman are valid for 5 years from the date of issue. Renewal should begin several months before expiry and requires current CE or FDA certificates, an updated ISO 13485 certificate and details of any device or manufacturing changes. Your AR maintains the listing and registration and manages renewals to avoid any gap in market access.
Can you help with IVD and SaMD registration?
Yes, NexorTest registers IVD devices and Software as a Medical Device with the Oman MOH DGPA&DC. IVDs follow the same Class A-D framework with their own IMDRF aligned rules, and we handle classification, performance evidence and labeling. For SaMD and AI/ML devices we manage software lifecycle, validation and cybersecurity documentation. Both benefit from CE or FDA reliance where available.
Ready to Enter the Omani Market?
Get a free Oman regulatory assessment from our GCC focused specialists. We’ll map your fastest, lowest risk path to MOH DGPA&DC market authorization.