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July 3, 2026
Approximately 5 minutes
Oman MOH Medical Device Registration: Circular 161/2025 Class C and D Step-by-Step Guide
Quick answer
Oman medical device registration MOH Class C Class D is now mandatory for high-risk products under Circular No. 161/2025, published by the Ministry of Health (MOH) Drug Safety Center on 6 July 2025. The circular implements Ministerial Decree 113/2020 and requires all medical device establishments to register manufacturers and their Class C and Class D devices before customs release. From 1 July 2026, shipment release will not be permitted unless registration is complete. Applications are filed through the MOH E-Health portal (eportal.moh.gov.om), following Guidance Document GD-22 for manufacturer registration and GD3 for product dossiers. Submit technical files at least two months before expected shipment arrival.
Who this applies to
This guide applies to:
- Local medical device establishments importing, distributing, or supplying Class C and Class D devices in Oman
- Foreign manufacturers whose products are placed on the Omani market through a local agent or establishment
- Regulatory affairs teams mapping EU MDR Class IIb/III, FDA Class II/III, or AIMD pathways to Oman's Class C and Class D framework
- Quality and RA managers preparing manufacturer registration under GD-22 before product filing under GD3
- Supply chain and logistics teams planning shipments ahead of the 1 July 2026 enforcement date
Scope covers moderate-high risk (Class C) and high risk (Class D) medical devices and supplies, including active implantable medical devices (AIMD), as defined in GD3. Class C aligns with international Class IIb/Class III devices; Class D covers Class III/Class IV/AIMD products. Lower-risk Class A and B devices follow separate MOH guidance and fee schedules but are outside the immediate Circular 161/2025 high-risk mandate.
Regulatory framework: Ministerial Decree 113/2020 and Circular 161/2025
Oman's medical device regulatory system rests on two primary instruments:
| Instrument | Role |
|---|---|
| Ministerial Decree 113/2020 | Foundational regulation for medical devices and supplies in the Sultanate of Oman; enforced by MOH Drug Safety Center |
| Circular No. 161/2025(6 July 2025) | Commences mandatory registration of high-risk medical device and suppliesmanufacturersand theirproducts; sets customs enforcement timeline |
| GD-22(Guidance Document) | Requirements for medical device and IVDmanufacturer registration |
| GD3(Guidance Document, October 2025) | Requirements forClass C and Class Dproduct registration dossiers |
Circular 161/2025 notifies all medical device establishments that:
- Registration of manufacturers and high-risk products must commence under Decree 113/2020
- Shipment release will not be allowed from 1 July 2026 unless the registration process is completed
- Technical files for high-risk products must be submitted through the MOH online portal at least two months prior to shipment arrival
- The Drug Safety Center is not responsible for customs clearance delays when registration is incomplete
- Voluntary registration is already available for establishments that wish to register ahead of the enforcement date
Both GD-22 and GD3 confirm that regulation is enforced in Oman via Ministerial Decree 113/2020 to ensure products entering the market are safe and effective.
Oman Class C vs Class D: risk mapping
GD3 maps Oman's national classification to internationally recognized risk categories:
| Oman class | Risk level | International equivalents (GD3) | Dossier sections required |
|---|---|---|---|
| Class C | Moderate-high individual and public health risk | Class IIb / Class III | All sectionsexcept 5 and 6 |
| Class D | High individual and public health risk | Class III / Class IV /AIMD | All sections(1 through 12) |
Incorrect risk classification may result in re-submission under the appropriate class. Verify classification before paying fees or uploading dossier sections, because MOH assigns fees by risk class and Class D files require additional design verification and validation content not required for Class C.
Regulator and portal: Drug Safety Center and E-Health portal
The Drug Safety Center (DSC), within MOH's Medical Device Control Department, administers manufacturer and product registration. All submissions use the MOH E-Health portal referenced in official guidance as the online registration channel (eportal.moh.gov.om).
| Service | Portal channel | Official MOH service page |
|---|---|---|
| Manufacturer registration | E-Health portal | Request for Registration of Medical Device Manufacturer |
| Product registration (Class C/D) | E-Health portal | Request for Registration of Medical Device |
| Variations (post-approval changes) | E-Health portal | Variation services after device registration is completed |
GD3 requires registration requirements to be presented in a clear, organized, readily searchable, and unambiguous manner, with all dossier sections documented and filled in the online platform. The MOH service page for product registration lists a 60 working day completion period and confirms delivery through the E-Health portal.
Prerequisites before product registration
GD3 and the MOH product registration service page define three prerequisites that must be completed before filing a Class C or Class D device:
| Prerequisite | Source | Purpose |
|---|---|---|
| Initial approval of wholesale activity | GD3 general requirements | Authorizes wholesale distribution of medical devices |
| Local medical device establishment approval | MOH service terms | Confirms the local establishment is approved to operate |
| Medical device manufacturer registration | GD-22 + MOH service terms | Registers the legal manufacturer; product Section 2 pulls data from this step |
Additional MOH service terms for product registration include:
- Copy of the commercial agency certificate
- Copy of the Medical Devices Manufacturer License
- Local agency certificate
GD-22 adds that applicants must complete the manufacturer license (fees apply), initial approval for wholesale activity, and local medical device establishment approval when the device will be sold on their behalf. Foreign manufacturers must provide a local agency certificate.
Step 1: Manufacturer registration under GD-22
Complete manufacturer registration before initiating any Class C or Class D product file. GD-22 Section 2 covers legal manufacturer information, including the quality management system and ISO 13485 certification.
Legal manufacturer details (GD-22 Section 2)
The portal requires structured data for the legal manufacturer:
| Field | Required content |
|---|---|
| Legal manufacturer name | Name of the entity with design/manufacture responsibility |
| Legal manufacturer country | Country of the manufacturing site |
| Postal and physical address | Full site addresses |
| Tel No, Fax No, Email | Contact details |
| QMS number | Quality management system identifier |
| QMS certificate expiry date | Validity of ISO 13485 or equivalent certificate |
Legal manufacturer attachments (GD-22 Section 2)
| Attachment | Purpose |
|---|---|
| Quality Management System (QMS) Certificate | TypicallyISO 13485 |
| Recent audit report | Evidence of QMS surveillance |
| Manufacturing / production process | Process overview |
| Manufacturer layout | Site layout documentation |
| Commerce agency certificate | Local agency relationship |
| Agreement between legal manufacturer and sub-contract manufacturer | Where subcontracting applies |
If sub-sites or sub-contractors are involved, GD-22 requires a separate sub-site/sub-contract block with parallel QMS details and attachments (QMS certificate, audit report, production process, layout).
Manufacturer registration fees and validity
| Applicant type | Fee | Validity period |
|---|---|---|
| Non-local manufacturer | 500 OMR | 5 years |
| Local manufacturer | 1,500 OMR | 3 years |
Manufacturer registration service completion is 60 working days. A copy of the Medical Devices Manufacturer License is required at product submission.
Step 2: Prepare the Class C or Class D product dossier under GD3
GD3 defines the medical device dossier structure. The sections below reflect the core filing blocks referenced in official guidance. Class D applicants must complete all sections; Class C applicants omit Section 5 (Essential Principles) and Section 6 (Summary of Design Verification and Validation) but must still satisfy remaining sections including clinical evidence, post-market controls, and declaration of conformity.
Section 1: Application type
| Element | What to declare |
|---|---|
| Application type | Medical device orIVD |
| Device name | Proprietary and generic identifiers |
| Risk classification | Class C or Class D |
| Device grouping | Single, family, system, or procedure pack (max 50 products per application) |
| Device category | Per MOH classification rules |
| Regulatory jurisdiction | KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others (specify) |
The jurisdiction selection drives which market certificates are expected in Section 7 (for example, CE/EC certificates for EU-route devices or PMA/510(k) for US-route devices).
Section 2: Manufacturer information
Product Section 2 is pre-populated from the completed manufacturer registration service. Confirm that legal manufacturer name, registration status, country/city, contact details, and ISO 13485 QMS certificate number and expiry match the GD-22 filing. For full manufacturer requirements, refer to GD-22.
Section 3: Medical device information
GD3 requires detailed device identity fields in the portal:
| Field category | Examples of required data |
|---|---|
| Identity | Trade / brand name, model name/number, serial number, manufacturer device ID |
| Classification | Medical device risk classification, medical device category |
| Clinical scope | Intended use, warnings, principles of operation / mode of action |
| Coding | GMDN, nomenclature code if different from GMDN,HS code |
| Logistics | Method of traceability, shelf life (months), storage conditions, first year sold |
| Product characteristics | Single-use flag, sterile flag, active ingredient (if applicable) |
| Visual | Picture or drawing with sufficient explanation |
| Dependencies | IT infrastructure or companion devices required for operation |
| Declarations | Animal tissue, medicines, or human blood derivatives (if applicable) |
Accessories marketed with the device may be included in the same registration unless sold separately. Accessory records require name, classification, GMDN, model number, label, catalogue, and IFU.
Section 4: Device labeling
Submit a complete labeling set:
- Instructions for Use (IFU)
- Label on the device
- Product labels and packaging
- Promotional materials / catalogue
Labeling must comply with IMDRF/GHTF labeling principles referenced in GD3.
Section 5: Essential principles and evidence of conformity (Class D only)
Class D dossiers must demonstrate conformity with IMDRF Essential Principles of Safety and Performance using the checklist in GD3 Annex 2. For each applicable principle, document:
- Applicability to the device
- Standards applied
- Method of conformity
- Identity of controlled documents providing evidence
Non-applicable principles require a documented rationale. Alternative formats are acceptable if all essential principles are addressed.
Section 6: Summary of design verification and validation (Class D only)
Class D files include design stages (procedure reference, stage descriptions, V&V confirmation) and manufacturing process information covering design/manufacturing sites, critical suppliers, subcontractor contracts, process flow, in-process testing, final inspection criteria, and manufacturing validation.
Section 7: Product verification and validation
Market certificates depend on the regulatory jurisdiction declared in Section 1:
| Jurisdiction | Class C (IIb/III) | Class D (III/IV/AIMD) |
|---|---|---|
| EU | CE/EC certificate, full QA, design examination | CE/EC certificate, full QA, design examination,TSE-free certificate(if biological) |
| USA | 510(k), PMA, others | PMA,AATB certificate(if biological, US origin), others |
Section 8: Clinical evidence
Include clinical evaluation report, stability testing, shelf-life testing, and software validation (if applicable).
Section 9: Post-market control
Manufacturers must prepare a Periodic Safety Update Report (PSUR) for each device (or category/group), summarizing post-market surveillance data, benefit-risk conclusions, PMCF findings, sales volume, and population exposure. Class C and Class D manufacturers must update the PSUR at least annually. A proactive post-market surveillance plan is required.
Section 10: Status of device distribution
List countries where the device is marketed with evidence, or provide a manufacturer letter confirming distribution. Submit a free sale certificate from the competent authority in the country of origin, or CFG (Certificate of Foreign Government) for US products, or CDNE where applicable.
Section 11: Declaration of conformity
The manufacturer declaration must include product name, model number, classification, a statement that the declaration is issued under the manufacturer's sole responsibility, and be issued/signed/stamped by the manufacturer.
Section 12: Benefit-risk analysis and risk management
Complete benefit-risk analysis and risk management documentation. GD3 notes that all dossier sections should be documented and filled in the online platform.
Product registration fees and timelines
| Risk class | Registration fee (MOH service page) | Review period |
|---|---|---|
| Class A–B | 100 OMR | 60 working days |
| Class C–D | 200 OMR | 60 working days |
Plan the full pathway—manufacturer registration, establishment approvals, dossier preparation, MOH review, and certificate issuance—within the two-month pre-shipment window specified in Circular 161/2025.
Step-by-step workflow
Step 1 — Confirm Class C or Class D classification under GD3
Step 2 — Obtain local establishment and wholesale activity approvals
Step 3 — Register manufacturer under GD-22 (ISO 13485, legal manufacturer Section 2)
Step 4 — Obtain Medical Devices Manufacturer License
Step 5 — Build GD3 dossier (Class C: omit Sections 5–6; Class D: all sections)
Step 6 — Submit via MOH E-Health portal (eportal.moh.gov.om)
Step 7 — Pay risk-based registration fee (200 OMR for Class C/D)
Step 8 — Respond to DSC queries within review period (60 working days)
Step 9 — Receive registration certificate before shipment
Step 10 — Maintain PSUR and apply variations for post-approval changes
Detailed workflow:
- Classify the device — Map to Class C or Class D using GD3 scope definitions; document rationale.
- Secure establishment approvals — Complete local medical device establishment approval and wholesale activity initial approval.
- Register the manufacturer — File GD-22 dossier with ISO 13485 QMS certificate, legal manufacturer details, and required attachments; pay manufacturer license fee.
- Link agency documentation — Upload commercial agency certificate and local agency certificate for foreign manufacturers.
- Prepare product dossier — Complete Sections 1–4 for all Class C/D devices; add Sections 5–12 per class requirements.
- Populate portal fields — Enter GMDN, HS code, intended use, trade name, classification, and remaining Section 3 fields.
- Submit through E-Health portal — File at least two months before planned shipment per Circular 161/2025.
- Pay product fee — 200 OMR for Class C or Class D registration.
- Track review — Allow up to 60 working days; respond promptly to additional MOH requests (DSC may request more requirements by product type).
- Plan post-market compliance — Annual PSUR updates for Class C and D; use variation services for design or labeling changes after registration.
Registration checklist
| Checklist item | Status |
|---|---|
| Device classified asClass C or Class Dunder GD3 | ☐ |
| Ministerial Decree 113/2020scope confirmed | ☐ |
| Local establishment approvalobtained | ☐ |
| Wholesale activity initial approvalobtained | ☐ |
| GD-22 manufacturer registrationcompleted | ☐ |
| ISO 13485 QMS certificatecurrent (Section 2) | ☐ |
| Medical Devices Manufacturer Licenseon file | ☐ |
| Commercial agency certificateandlocal agency certificateuploaded | ☐ |
| Section 3 fields complete:GMDN,HS code,intended use,trade name,classification | ☐ |
| Labeling pack (IFU, device label, packaging) prepared (Section 4) | ☐ |
| Class D: Sections 5–6 (essential principles, design V&V) completed | ☐ |
| Section 7 market certificates matched to declared jurisdiction | ☐ |
| Clinical evidence andPSUR/PMS planready (Sections 8–9) | ☐ |
| Declaration of conformitysigned (Section 11) | ☐ |
| Application submitted viaE-Health portal≥2 months before shipment | ☐ |
| Product registration fee paid (200 OMRfor Class C/D) | ☐ |
| Registration certificate received before1 July 2026enforcement | ☐ |
Common pitfalls
- Filing product before manufacturer registration — GD3 Section 2 pulls from the manufacturer service; incomplete GD-22 blocks product intake.
- Wrong risk class — Misclassified Class D devices filed as Class C trigger re-submission and delay customs clearance.
- Missing ISO 13485 evidence — GD-22 requires QMS certificate, number, and expiry in legal manufacturer Section 2.
- Incomplete Section 3 coding — Omitting GMDN or HS code creates searchable-field gaps MOH expects in the portal.
- Late submission vs. shipment — Circular 161/2025 requires technical files two months before arrival; the DSC disclaims responsibility for clearance delays when registration is incomplete.
- Treating Class C like Class D (or vice versa) — Class C omits Sections 5 and 6; Class D requires full essential principles and design V&V summaries.
- Ignoring PSUR obligations — Class C and D manufacturers must update PSURs at least annually under GD3 Section 9.
- Variations filed as new registrations — Post-approval changes must use MOH variation services, not duplicate product applications.
FAQ
What does Circular 161/2025 require for Oman medical device registration MOH Class C Class D?
Circular 161/2025, dated 6 July 2025, requires all medical device establishments to register high-risk manufacturers and their Class C and Class D products under Ministerial Decree 113/2020. From 1 July 2026, shipment release will not be permitted without completed registration. Establishments may register voluntarily before that date through the MOH E-Health portal.
How do I register a medical device manufacturer in Oman before filing Class C or D products?
Complete GD-22 manufacturer registration on the MOH E-Health portal first. Prerequisites include the manufacturer license (fees apply), initial wholesale activity approval, and local establishment approval. GD-22 Section 2 requires legal manufacturer details and ISO 13485 QMS certification with supporting attachments (audit report, production process, layout, agency certificates).
What is the difference between Class C and Class D dossier requirements in GD3?
Class C (moderate-high risk; Class IIb/III equivalent) requires all dossier sections except 5 and 6. Class D (high risk; Class III/IV/AIMD equivalent) requires all sections, including essential principles, design verification and validation summaries, clinical evidence, post-market controls, distribution status, declaration of conformity, and benefit-risk analysis.
Which device fields must I enter in the MOH online portal for product registration?
GD3 Section 3 requires trade/brand name, model identifiers, medical device risk classification, intended use, GMDN, HS code, device category, traceability method, storage and shelf-life data, sterility and single-use flags, and supporting images or drawings. Accessories bundled with the device require parallel identification and labeling uploads.
What fees apply to Oman MOH Class C and Class D medical device registration?
The MOH Request for Registration of Medical Device service lists 200 OMR for Class C and Class D products and 100 OMR for Class A and B. Manufacturer registration under GD-22 is charged separately: 500 OMR for five years (non-local manufacturer) or 1,500 OMR for three years (local manufacturer).
How long does MOH take to review a Class C or Class D registration application?
The official MOH product registration service specifies a 60 working day completion period via the E-Health portal. Circular 161/2025 additionally expects applicants to submit technical files at least two months before shipment arrival to avoid customs delays.
Can I import high-risk medical devices into Oman before 1 July 2026 without registration?
Circular 161/2025 states that voluntary registration is already active and encourages early submission. Mandatory enforcement begins 1 July 2026, when shipment release will not be allowed unless registration is complete. Planning manufacturer and product registration well ahead of that date reduces supply-chain risk.
Where do I apply for Oman medical device registration online?
Apply through the MOH E-Health portal referenced in GD-22 and GD3 official guidance (eportal.moh.gov.om). Service entry points include Request for Registration of Medical Device Manufacturer and Request for Registration of Medical Device on moh.gov.om.
Official sources
- Ministry of Health — Circular No. 161/2025: Commencement of Registration of High Risk Medical Devices & Supplies Manufacturers & Their Products (6 July 2025): https://moh.gov.om/en/ministry/drug-safety-center-circulars/cirno161-of-2025-regarding-commencement-of-registration-of-high-risk-medical-devices-supplies-manufacturers-their-products/
- Ministry of Health — Guidance Document GD3: Guideline on Requirements of Class C & D Medical Devices Registration in Sultanate of Oman (October 2025): https://www.moh.gov.om/media/ov3mnntj/guidance-document-gd3-guideline-on-requirements-of-class-c-d-medical-devices-registration.pdf
- Ministry of Health — Guidance Document GD-22: Guideline on Requirements of Medical Device Manufacturer Registration in Sultanate of Oman: https://www.moh.gov.om/media/ubmn0pgh/guidance-document-gd-22-guideline-on-requirements-of-medical-device-manufacturer-registration-in-sultanate-of-oman.pdf
- Ministry of Health — Request for Registration of Medical Device: https://www.moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device/
- Ministry of Health — Request for Registration of Medical Device Manufacturer: https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer/
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