Deadline Approaching for Medical Device Companies in Oman

The deadline fast approaches in Oman for medical device manufacturers and importers to update their status under the new Omani regulatory framework, with a requirement to comply by 22 October 2026.

The requirement applies to all medical devices imported into Oman, including but not limited to diagnostic, therapeutic, and surgical equipment.

Medical device supply companies in Oman wishing to submit registration applications to the Ministry of Health (MOH) must first apply for facility registration through the Ministry’s electronic portal. Only companies registered in the Ministry’s records will be able to apply for services related to medical devices – such as the registration of their products, as well as the service for importing and releasing these products.

Non-compliant shipments risk being rejected at entry points.

Regulatory Background

This directive sits within a broader regulatory architecture underpinned by Executive Regulation No. 113/2020 of the Law Regulating the Practice of the Pharmacy Profession and Pharmaceutical Institutions (the “Executive Regulation”), which provides the foundational legal basis for the regulation of medical devices and supplies in the Sultanate.
In February 2026, the MOH Drug Safety Center issued a circular linking medical device establishment’s approval to the clearance of medical device supplies, meaning that the MOH’s approval of an establishment is now a prerequisite for the release of incoming medical device shipments at customs.

Impact

From 22 October, clearance procedures will not be completed unless the establishment clearing the incoming shipment is approved by the Medical Devices Control Department. Unapproved establishments will be rejected from importing medical devices.

Practical next steps for affected companies

In light of the approaching deadlines, medical device manufacturers, importers, and distributors operating in Oman should consider the following actions:

1. Assess current registration status. Determine whether your establishment holds a valid approval from the MOH’s Medical Devices Control Department and whether your products (particularly Class C and Class D devices) are registered or in the process of being registered.
2. Initiate establishment registration promptly. Companies that have not yet applied for establishment approval should do so without delay through the MOH E-Health portal, given the lead time required for processing, and the 22 October 2026 deadline.
3. Prepare manufacturer registration dossiers. Foreign manufacturers supplying the Omani market through local agents should ensure that manufacturer registration under GD-22 is completed (including current ISO 13485 certification), as product registration cannot proceed without it.
4. Appoint or confirm an Omani authorised representative. Companies not established in Oman must have a local authorised representative with a valid commercial registration to submit applications on their behalf.
5. Review supply chain planning. Given that non-compliant shipments will be rejected at entry points from 22 October 2026, companies should review import schedules and ensure that all necessary registrations and approvals are secured before dispatching shipments to Oman.
6. Monitor ongoing regulatory developments. The MOH Drug Safety Center continues to issue circulars and updated guidance. Companies should monitor the Drug Safety Center circulars page on the MOH website

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