Overview of Medical Device Regulation in Oman
The healthcare sector in Oman is expanding rapidly, offering major opportunities for medical device manufacturers worldwide. However, before entering this growing market, understanding the medical device regulation in Oman is crucial. The Directorate General of Pharmaceutical Affairs and Drug Control (DGPADC) under the Ministry of Health (MoH) oversees the approval and registration of all medical devices to ensure patient safety and product quality.
This blog provides a step-by-step guide to medical device regulation in Oman, covering classification, registration procedures, and documentation requirements—helping manufacturers achieve fast and smooth approvals.
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Regulatory Authority for Medical Devices in Oman
The DGPADC under Oman’s Ministry of Health is responsible for implementing and monitoring medical device regulation in Oman. The authority ensures that only devices meeting international safety and performance standards are approved for use.
Key functions of DGPADC:
- Reviewing and approving medical device registration applications
- Verifying technical documentation and product quality
- Issuing import and marketing authorizations
- Conducting post-market surveillance and inspections
Classification of Medical Devices in Oman
Oman’s classification framework under medical device regulation aligns with global models such as the EU MDR and GHTF. Devices are categorized based on risk:
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low risk | Bandages, thermometers |
| Class II | Moderate risk | Contact lenses, dental materials |
| Class III | High risk | Pacemakers, implantable devices |
Step-by-Step Process for Medical Device Regulation in Oman
Step 1: Appoint a Local Authorized Representative
Foreign manufacturers must appoint a local authorized representative or distributor in Oman. This entity handles regulatory communication and submits documentation to the DGPADC on your behalf.
Step 2: Prepare the Technical Documentation
To comply with medical device regulation in Oman, manufacturers must submit a comprehensive technical file including:
- Device description and intended use
- Manufacturing process and quality system details
- Clinical or performance data
- ISO 13485 certificate
- Risk assessment and management reports
Step 3: Application Submission to DGPADC
The complete dossier is submitted for review. Applications are assessed for safety, efficacy, and conformity with Oman’s MoH requirements.
Step 4: Review and Registration Approval
If the submission meets all regulatory criteria, the DGPADC issues a registration certificate, permitting the device’s import and distribution in Oman.
Step 5: Import and Distribution Licensing
Manufacturers or their authorized representatives must obtain import licenses before placing the device on the Omani market.
Step 6: Post-Market Surveillance
Under the medical device regulation in Oman, manufacturers are required to monitor product performance and report adverse events or recalls.
Essential Compliance Requirements
Common Challenges in Meeting Oman’s Regulatory Requirements
Manufacturers often face challenges such as:
- Incomplete or outdated technical files
- Misclassification of device risk category
- Lack of local authorized representation
- Unawareness of updated DGPADC guidelines
Working with an expert consultant helps avoid these issues and ensures full compliance with medical device regulation in Oman.
Ready to Launch Your Medical Devices in Oman?
Why Choose Operon Strategist for Regulatory Support
At Operon Strategist, we specialize in medical device regulation and registration in Oman. Our team offers:
- Device classification and regulatory pathway analysis
- Technical documentation and dossier preparation
- ISO 13485 certification support
- Assistance in communication with the DGPADC
With our in-depth expertise, we help manufacturers achieve faster product approval and ensure full compliance with Omani medical device regulations.
FAQs
Who regulates medical devices in Oman?
The Directorate General of Pharmaceutical Affairs and Drug Control (DGPADC) under the Ministry of Health regulates medical devices in Oman.
Is ISO 13485 certification mandatory?
Yes, ISO 13485 certification is required to demonstrate a compliant quality management system for medical device manufacturers.
How long does the registration process take?
It usually takes 3–6 months, depending on the class of the device and documentation completeness.
Can a foreign company register a device without a local partner?
No. Under medical device regulation in Oman, a local authorized representative or distributor must handle the registration process.