Ministry of Health · structured requirements

🇴🇲 Oman IVD regulatory data

Explore the IVD requirements currently available for Oman, organized by topic and linked to official sources.

4 facts2 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Oman

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Classification rules

What local class follows from which rules and decisive product facts?

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Classification detail 2

classification.detail-2

Fact-level verified

Oman's risk class is determined by the classification of the device in its country-of-origin jurisdiction (KSA MDMA, USA, EU, Canada, Australia, Japan or other), stated in the application Section 1

Classification detail 3

classification.detail-3

Fact-level verified

Applications with incorrect risk classification may be required to re-submit according to the appropriate risk class (GD3 Chapter Two item 5)

Classification scheme (full axis)

classification.scheme-classes

Fact-level verified

Axis

GHTF-style risk classes A through D set by MoH Circular 182/2021.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

Ministry of Health

Notes

Mapping per Circular 182/2021 risk-classification table: Class A (low) = Class I devices and general/exempt IVDs; Class B (low-moderate) = Class II / Class IIa and self-test IVDs; Class C (moderate-high) = Class IIb / Class III and Annex II List B IVDs; Class D (high) = all other Class III / Class IV / AIMD and Annex II List A IVDs.
Risk class is determined by the device's classification in its country-of-origin jurisdiction (KSA MDMA, USA, EU, Canada, Australia, Japan or other), stated in application Section 1.
Applications with incorrect risk classification may be required to re-submit according to the appropriate risk class (GD3 guideline, Chapter Two item 5).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Oman approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Oman (3 records)

OmanEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: 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.
Timeline Savings: None published

Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

OmanUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Accepted for the same document slot as a CE certificate, with no published reduction.
Timeline Savings: None published

Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

OmanNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: Oman's Class C&D registration guideline lets the applicant declare the regulatory jurisdiction the device follows, with an open 'Others (specify)' option, and requires in Section 10 a free sale certificate from the competent authority in the country of origin. A Chinese manufacturer can therefore file under 'Others' with NMPA-based origin evidence (NMPA registration certificate / China free-sale certificate), but the guideline defines product-certificate expectations only for the EU and US routes and offers no abridged review for NMPA approval.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: oman
China Classes In Scope: Class C (IIb/III) and Class D (other III/IV/AIMD) medical devices, i.e. NMPA Class II/III devices falling in Oman's C/D bands
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Section 1 application must state the jurisdiction followed: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others (specify)
Section 7 'Product Verification and Validation' lists certificates only for EU-route (CE/EC certificate, full QA, design examination, TSE-free) and US-route (510(k)/PMA, AATB) devices, each with an 'Others' line
Section 10 requires a free sale certificate from the competent authority in the origin country (or CFG/CDNE for US products) plus a list of countries where marketed
Full dossier (Sections 1-11 for Class D; all except 5 and 6 for Class C) and manufacturer registration remain required
Risk classification follows the country-of-origin jurisdiction
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-11-18

Source passage: Regulatory jurisdiction the device follows: • KSA (MDMA) • USA • EU • Canada • Australia • Japan • Others (specify) [...] Submit free sale certificate from competent authority in origin country or certificate of foreign government CFG if the product from USA and CDNE (certificate for medical device not exported from the United States).

Related structured datasets

Classification systems · 1 record

Open GHTF-style risk classes A through D set by MoH Circular 182/2021. →

Id

oman:medical-device

Jurisdiction Id

oman

Domains

medical-device
ivd

Name

GHTF-style risk classes A through D set by MoH Circular 182/2021.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

Ministry of Health

Official Domains

moh.gov.om

Notes

Mapping per Circular 182/2021 risk-classification table: Class A (low) = Class I devices and general/exempt IVDs; Class B (low-moderate) = Class II / Class IIa and self-test IVDs; Class C (moderate-high) = Class IIb / Class III and Annex II List B IVDs; Class D (high) = all other Class III / Class IV / AIMD and Annex II List A IVDs.
Risk class is determined by the device's classification in its country-of-origin jurisdiction (KSA MDMA, USA, EU, Canada, Australia, Japan or other), stated in application Section 1.
Applications with incorrect risk classification may be required to re-submit according to the appropriate risk class (GD3 guideline, Chapter Two item 5).

Source Status

official-source-verified

Source Title

Oman MoH Circular No. 182/2021 — Risk Classification of Medical Device

Source Url

https://www.moh.gov.om/media/1feofpzm/md-regulation-circulars-updates-in-oman.pdf

Verified On

2026-08-25

Source Supports

class-axis
ivd-class-axis

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Oman registration →

Country

Oman

Jurisdiction Id

oman

Country Code

OM

Flag

🇴🇲

Regulator

Oman Ministry of Health

Regulator Abbrev

Ministry of Health

Region

middle-east

Tier

3

Risk Classification

4-class (A, B, C, D) — GCC-aligned

Classes

Id
device-registration
Class Name
Medical-device registration service
Pathway
MoH registration
Official Timeline
Min
60
Max
60
Unit
working-days
Realistic Timeline
Min
3
Max
5
Unit
months
Notes
MoH service catalogue: 60 working days; the service page does not allocate separate clocks by risk class
Risk class drives the fee rather than the clock: OMR 100 for Class A-B and OMR 200 for Class C-D
The service will not start until the manufacturer is separately registered and the local establishment approved
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Accessed Date
2026-08-30
Id
manufacturer-registration
Class Name
Medical-device manufacturer registration
Pathway
MoH manufacturer registration
Official Timeline
Min
60
Max
60
Unit
working-days
Realistic Timeline
Min
3
Max
5
Unit
months
Notes
MoH service catalogue: 60 working days, and this step gates the product registration rather than running alongside it
Registration lasts 5 years for a non-local manufacturer at OMR 500 and 3 years for a local manufacturer at OMR 1,500; re-registration is a separate service on the same 60-working-day clock
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Accessed Date
2026-08-30
Id
device-re-registration
Class Name
Medical-device re-registration
Pathway
MoH re-registration
Official Timeline
Min
60
Max
60
Unit
working-days
Realistic Timeline
Min
3
Max
5
Unit
months
Notes
MoH service catalogue: 60 working days, the same clock and the same documentary conditions as an original registration
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-re-registration-of-medical-device
Accessed Date
2026-08-30
Id
unregistered-device-import
Class Name
Import authorisation for a non-registered device
Pathway
MoH import authorisation
Official Timeline
Min
30
Max
30
Unit
working-days
Realistic Timeline
Min
1.5
Max
3
Unit
months
Notes
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
This is the route that lets an unregistered device reach the market, so it is the practical alternative to the 60-working-day registration rather than a step within it
Gmp Required
No
Verification Status
official-verified
Official Source
Title
Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
Accessed Date
2026-08-30
Id
product-classification
Class Name
Product classification ruling
Pathway
MoH classification
Official Timeline
Min
30
Max
30
Unit
working-days
Realistic Timeline
Min
1.5
Max
3
Unit
months
Notes
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
Borderline products need this ruling before the correct registration route can even be opened
Gmp Required
No
Verification Status
official-verified
Official Source
Title
Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/apply-for-product-classification
Accessed Date
2026-08-30

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

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
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.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Accepted for the same document slot as a CE certificate, with no published reduction.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Omani Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years for the device and for a non-local manufacturer registration; 3 years for a local manufacturer registration

Last Updated

2026-08-30

Verification Status

official-verified

Official Sources

Title
Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-re-registration-of-medical-device
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/apply-for-product-classification
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
Accessed Date
2026-08-30
Title
Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Omani Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
60 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Oman market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Oman fees →

Jurisdiction Id

oman

Country

Oman

Country Code

OM

Authority

Ministry of Health

Low Risk Local

Min: 100
Max: 100
Currency: OMR
Per Product: Yes

High Risk Local

Min: 200
Max: 200
Currency: OMR
Per Product: Yes

Details

Id
device-registration-class-a-b
Item
Device registration - Class A/B
Currency
OMR
Amount Local
100
Amount Local Formatted
OMR 100
Frequency
Per registration
Notes
Re-registration carries the same fee.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Source Title
Oman MoH: request for registration of a medical device (fees)
Verified On
2026-08-25
Id
device-registration-class-c-d
Item
Device registration - Class C/D
Currency
OMR
Amount Local
200
Amount Local Formatted
OMR 200
Frequency
Per registration
Notes
Re-registration carries the same fee.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Source Title
Oman MoH: request for registration of a medical device (fees)
Verified On
2026-08-25
Id
manufacturer-registration-non-local
Item
Manufacturer registration - non-local manufacturer
Currency
OMR
Amount Local
500
Amount Local Formatted
OMR 500
Frequency
Per registration (5 years)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Source Title
Oman MoH: registration of a medical-device manufacturer (fees)
Verified On
2026-08-25
Id
manufacturer-registration-local
Item
Manufacturer registration - local manufacturer
Currency
OMR
Amount Local
1500
Amount Local Formatted
OMR 1,500
Frequency
Per registration (3 years)
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Source Title
Oman MoH: registration of a medical-device manufacturer (fees)
Verified On
2026-08-25
Id
device-variation
Item
Medical device variation
Currency
OMR
Amount Local
25
Amount Local Formatted
OMR 25
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
Source Title
Oman MoH: medical-device variation request (fee)
Verified On
2026-08-25
Id
customs-clearance
Item
Release/customs clearance of medical devices and supplies
Currency
OMR
Amount Local
5
Amount Local Formatted
OMR 5
Frequency
Per consignment
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
Source Title
Oman MoH: clearance/release of medical devices and supplies (fee)
Verified On
2026-08-25

Notes

No fee is charged for the import-of-unregistered-devices permit or for activation of the medical-devices sale activity.
Service pages publish figures without a currency symbol; Omani Rial is confirmed as the currency on gov.om.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Oman MoH: request for registration of a medical device (fees)
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Accessed Date
2026-08-25
Title
Oman MoH: registration of a medical-device manufacturer (fees)
Url
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Accessed Date
2026-08-25
Title
Oman MoH: medical-device variation request (fee)
Url
https://www.moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
Accessed Date
2026-08-25
Title
Oman MoH: clearance/release of medical devices and supplies (fee)
Url
https://www.moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
Accessed Date
2026-08-25
Title
Oman MoH: import permit for non-registered medical devices (no fee)
Url
https://www.moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Oman certifications →

Slug

oman

Market

Oman

Confidence

low

Schemes

Id
moh-manufacturer-registration-iso-13485
Name
MoH manufacturer registration ISO 13485
Category
Medical Electrical Safety
Status
Mandatory Pre Market
Object
Manufacturer Site
Note
GD-22 Chapter Two §2: medical device and IVD manufacturer registration requires an ISO 13485/QMS certificate (with number and expiry) plus a recent audit report.
Source Urls
https://www.moh.gov.om/media/ubmn0pgh/guidance-document-gd-22-guideline-on-requirements-of-medical-device-manufacturer-registration-in-sultanate-of-oman.pdf
Source Binding
reviewed
Id
reference-jurisdiction-certificates
Name
Reference-jurisdiction certificates (CE/510(k)/PMA)
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
GD-3 Chapter Two §7: EU-jurisdiction devices need a CE/EC certificate or full quality-assurance / design-examination certificate (Class D adds a TSE-free certificate if biological); US-jurisdiction devices need 510(k) or PMA (Class C) and PMA plus AATB certificate if biological (Class D); IVD Class C accepts PMA or 510(k). Chapter Two §8 (Clinical evidence) adds the clinical evaluation report, stability testing, shelf-life testing and software validation.
Source Urls
https://www.moh.gov.om/media/ov3mnntj/guidance-document-gd3-guideline-on-requirements-of-class-c-d-medical-devices-registration.pdf
Source Binding
reviewed

Official Sources

Authority
Oman Ministry of Health
Topic
GD-22 manufacturer registration — ISO 13485 certificate and audit report
Url
https://www.moh.gov.om/media/ubmn0pgh/guidance-document-gd-22-guideline-on-requirements-of-medical-device-manufacturer-registration-in-sultanate-of-oman.pdf
Authority
Oman Ministry of Health
Topic
GD-3 class C/D registration — CE/510(k)/PMA evidence and testing overlays
Url
https://www.moh.gov.om/media/ov3mnntj/guidance-document-gd3-guideline-on-requirements-of-class-c-d-medical-devices-registration.pdf

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Need to apply Oman's requirements to a product?

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