Oman medical device registration timeline
Source-linked clocksOman Ministry of Health (Ministry of Health) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — GCC-aligned classification system.
5 pathways5 of 5 clocks verifiedvalidity 5 years for the device and for a non-local manufacturer registration; 3 years for a local manufacturer registrationMDSAP not acceptedreviewed 2026-08-30moh.gov.om
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Medical-device registration service(MoH registration) MoH service catalogue: 60 working days; the service page does not allocate separate clocks by risk class | 60 working days | 3-5 months | — | Verified |
| Medical-device manufacturer registration(MoH manufacturer registration) MoH service catalogue: 60 working days, and this step gates the product registration rather than running alongside it | 60 working days | 3-5 months | — | Verified |
| Medical-device re-registration(MoH re-registration) MoH service catalogue: 60 working days, the same clock and the same documentary conditions as an original registration | 60 working days | 3-5 months | — | Verified |
| Import authorisation for a non-registered device(MoH import authorisation) MoH service catalogue: 30 working days and no fee, available where the device activity is already active in the commercial registry and the local establishment is approved | 30 working days | 1.5-3 months | — | Verified |
| Product classification ruling(MoH classification) MoH service catalogue: 30 working days to rule whether a product is a pharmaceutical, herbal, health product, medical device or unspecialised, based on composition, form and medical claims | 30 working days | 1.5-3 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Oman Medical Device Registration Process
Step-by-step Ministry of Health registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Omani Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMinistry of Health reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
60 working daysIn-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Ministry of Health issues Oman market authorization certificate.
Summary: The Oman medical device registration process through Oman Ministry of Health (Ministry of Health) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
CE Mark (EU MDR)A conformity certificate and a certificate of free sale from the country of origin are what the dossier is built on. The published service period does not change with origin.None published
FDA 510(k)/PMAAccepted for the same document slot as a CE certificate, with no published reduction.None published
Key requirements
- Local Authorized Representative required for foreign manufacturers, evidenced by a commercial agency certificate
- Two short published clocks sit either side of the registration: activating the medical devices and supplies activity in the commercial registry takes 1-2 working days, and customs clearance or release of a consignment takes one working day
- Ministerial Decision No. 113/2020 governs registration of medical device companies and their products, and is the instrument the service pages point to
- Two device steps are published with no period at all, and both should be treated as unbounded: the variation service leaves its completion period blank, and the pharmaceutical establishment or device facility approval answers only that it "depends on adhering to the requirements and employing employees of the Pharmaceutical Corporation"
- GCC common-registration dossier format accepted
Primary regulator sources
moh.gov.om · Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days moh.gov.om · Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days moh.gov.om · Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days moh.gov.om · Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days moh.gov.om · Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days moh.gov.om · Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day moh.gov.om · Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)
Reviewed 2026-08-30. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against Ministry of Health publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:oman:device-registration