Medical Device Registration in Oman

Your application will be overseen and examined by the Directorate General for Pharmaceutical Affairs and Drug Control, which is regulated by the Ministry of Health. Just make sure to apply through their online portal.

Common standards include ISO 13485, CE marking, and US FDA approvals, which give more weight to your devices than non-registered ones.

While Oman doesn’t have a single regulation or standard law that governs medical devices, much like the EU or the UAE, the system is governed by a series of guidelines, circulars, MOH requirements, and ministerial decisions. Get in touch with Oman health compliance experts to learn more about these regulatory rules.

The devices are categorized into four classes, namely:

1. Low-risk products like bandages and stethoscopes.
2. Low to moderate: syringes and surgical masks.
3. Moderate to high risk: pacemakers and X-ray machines.
4. High risk: defibrillators and metal heart valves.

Common documents that you will need to enrol your medical devices in Oman include the application form, ISO 13485 certificate, a CFS, CE/FDA clearance, official declaration by the manufacturers, instruction guide, user manual, technical manual, power of attorney, and authorization letters for the authorized representative.

Yes, you need an ISO 13485 certification because it proves that your company maintains a specific standard- a quality management system for patient safety, risk, and traceability of the product.

Although it is not mandatory for every manufacturer to hold a CE marking or FDA approval, you will definitely increase your chances of approval because the ministry is very strict about healthcare devices. They won’t accept your product unless it's certified by a global standard like ISO 13485 and already sold in free markets like the EU, Japan, Canada, Australia, and the US.
Therefore, a CE mark or an FDA approval will certainly give you a better advantage.

Yes, you need a CFS if you want to register your medical device in Oman because the document verifies that your device is legally approved and freely marketed in your own country (of origin) without any export restrictions. In simple terms, it means your device is fully compliant with regulatory and public safety rules before it enters the Omani market.

Your timeline depends on the complexity of your device- if it's a standard low-risk one, then you will get the approval within 3 to 6 months, and applications involving high-risk devices take around 6 to 9 months. If you want to expedite and reduce the delays, then you must have proper documentation, clear certificates, and on-time query resolutions.

A medical device registration in Oman is valid for five years from the date of its official approval. You must renew it well before the expiration date if you want to keep your business active in Oman’s market. Businesses with invalid registrations often face hefty penalties and other consequences, such as lawsuits and prosecution.

A medical device registration is basically a formal approval that validates your product’s safety and efficacy. In contrast, an import license is more about an approval for shipment that physically brings a product/device into Oman.

Yes, the GCC provides guidelines that streamline the application process for Oman medical device registration; you will still need to undergo Oman’s review for your medical device registration, as regulated under the Ministry of Health.

Only Oman-based local entities that can act as an authorized representative for a foreign manufacturer, registered Omani importers and distributors, and local-resident licensed manufacturers.

If your application or dossier is incomplete, it may be rejected; you may receive a deadline for resubmission; your import may be delayed; and you may also face a market ban if your products remain unregistered.

At Enterslice, we manage the classification of your device, preparation of the dossier, legalization & attestation of paperwork, filing with the MOH, handling the ministry’s queries, managing the import licensing documentation, renewals of the registration, and managing post-licensing requirements.