Medical Device Compliance in Oman

Not at all. Foreigners aren’t allowed to register a medical device without the assistance of a locally registered representative as their liaison support and for import/distribution in Oman. So, you will have to appoint a representative to file the form on your behalf.

Yes, ISO 13485 certification is needed before you apply for the registration because it is basically proof that your device meets the global quality management safety protocols and lays down the procedure for risk management/product traceability.

Depending on your device classification, you will need to prepare the dossier and legal papers. The authority also conducts an extensive review of moderate- to high-risk classes compared to low and moderately low ones.

Post-market surveillance is an ongoing and continuous activity that monitors the safety and performance of your device after launch and distribution. You can track the device, detect issues, and take corrective actions against them.

You will need to track and report adverse events and safety incidents that involve your medical devices to the MOH for consumer safety. It is through this mechanism that you initiate a recall of the affected devices.

In a recall, you either remove or repair the affected medical devices. The same should be notified to the MOH and customers as well. The process is a part of post-launch management to safeguard public health.

• The labels and instructions for use must be in both Arabic and English.
• Include manufacturer details, legal information, registered address, and contact number/email ID.
• Batch number with lot/unique device number.
• Date of manufacture and expiration date (if needed).
• How to store: specific instructions
• Warnings and precautions, if any.

Yes, all your registered devices need to get an import permit, which is obtained by your licensed establishment in Oman. You will not be able to import the devices into the country without the required approval.

In case you fail to comply with Oman medical device regulations, you will face heavy monetary penalties, cancellation of registration, logistical issues, loss of reputation/partnership in the market, and unexpected inspections that would lead to interrupted operations and business loss.

Your compliance includes registration via an authorized representative, import approval for each consignment, labelling, QMS, recall management, renewal, variation reporting, and post-market surveillance.

You will need to renew your registration at least 90 to 180 days before your current one expires, so you don’t have to face shipment delays, legal issues, operations without valid registration, seizure of consignment by customs, and re-export expenses.

Absolutely, any software that supports surgeries or diagnostics, like SaMD (AI and diagnostic apps) and SiMD (MRI machines and robotic machines), falls under the registration with the MOH.

The GCC rules harmonize certain requirements, like similar classes of device categories for registration, but each country has its own rules, regulations, and authorities for registration and compliance.

While registration allows you to introduce a medical device into the market, compliance is an ongoing process that constantly assists you in fulfilling obligations throughout the lifecycle of the device registration.