Oman medical device registration timeline

Source-linked clocks

Oman Ministry of Health (MoH) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — GCC-aligned classification system.

1 pathways1 of 1 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-25

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

Review clocks exclude applicant hold time · planning totals are estimates

Oman Medical Device Registration Process

Step-by-step MoH registration process. Total estimated timeline: 3-5 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a Omani Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MoH including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MoH reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

60 working days

In-depth technical assessment of device safety and performance. MoH may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MoH issues Oman market authorization certificate.

Summary: The Oman medical device registration process through Oman Ministry of Health (MoH) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative required for foreign manufacturers
Import permits: 30 working days (customs clearance 1 working day; activation 1-2 working days)
Vigilance reporting: 90 working days for periodic summaries
GCC common-registration dossier format accepted

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Source-linked review clocks verified against MoH publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:oman:device-registration