Explore the medical device requirements currently available for Oman, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
A 'Re-registration of Medical Device' service exists (60 working days, same class-based fees 100/200, commercial agency certificate required) to re-register a device; the registration certificate validity period for devices is not stated in GD3/GD5 or the service pages.
The manufacturer registration fee is posted as 500 (non-local manufacturer, five years) and 1,500 (local manufacturer, 3 years) on the registration service page, indicating the registration periods; a re-registration service exists with the same fees.
GD-22 renewal flow: renew application with re-submission of expired documents.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Any variation in a registered medical device or registered manufacturer must be applied for through the variation service after registration; the service requires a justification letter for the variation and follows Ministerial Decision No. 113/2020 (fee 25).
GD3/GD-22 notes state variations go through variation services.
What local class follows from which rules and decisive product facts?
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
Applications with incorrect risk classification may be required to re-submit according to the appropriate risk class (GD3 Chapter Two item 5)
GHTF-style risk classes A through D set by MoH Circular 182/2021.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
Ministry of Health
Which clinical or IVD performance evidence or study is required and accepted?
IVD Class C&D registration requires clinical performance and analytical performance documentation plus stability testing, shelf-life testing and software validation.
Class C&D registration requires clinical evidence comprising a clinical evaluation report, stability testing, shelf-life testing and software validation where applicable; the evidence is submitted as part of the origin-jurisdiction dossier.
Is the product a device, IVD, accessory, software, or borderline product locally?
IVD medical device means a medical device intended for in-vitro examination of specimens derived from the human body, solely or principally to provide information on physiological/pathological states, congenital abnormality, predisposition, safety/compatibility, treatment prediction or monitoring; includes kits, reagents, calibrators, control materials, specimen receptacles, software and related instruments.
Same definition in GD5; sourced from WHO 2017 IVD definition per references.
Oman adopts the GHTF/WHO-style definition: any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar article intended by the manufacturer for specified medical purposes, not achieving its principal intended action by pharmacological, immunological or metabolic means.
Identical definition in GD3 and GD5; references WHO Medical Device Definition and IMDRF terms.
Which evidence, local deltas, formats, and signatures are required?
The IVD Class C&D dossier mirrors the medical-device structure: Class D (Annex II List A) requires all sections; Class C (Annex II List A moderate-high risk) all sections except 5 and 6; Section 8 for IVDs covers clinical performance, analytical performance, stability and shelf-life testing and software validation.
The Class C&D dossier follows a CSDT-style structure of 12 sections (application type, manufacturer information, device information, labeling, essential principles, design V&V summary, product V&V, clinical evidence, post-market control, distribution status, declaration of conformity, benefit-risk analysis); Class D requires all sections, Class C all except sections 5 and 6.
Based on AHWP CSDT (AHWP/WG1/F001:2015) and IMDRF essential principles per references.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Device registration requires a local agency: a copy of the commercial agency certificate and a local agency certificate; for foreign manufacturers the manufacturer registration requires a local agency certificate.
Manufacturer registration service page states 'Local agency certificate for Foreign manufacturer'.
All medical device manufacturers (local and foreign) must be registered with DSC before their products can be registered; registration of a foreign manufacturer is applied for through the local agent and requires a copy of the Medical Devices Manufacturer License.
GD-22 governs the requirements; registration service period 60 working days.
Which establishment licences, importer permissions, and distribution controls apply?
Circular No. 15 of 2026 (19/02/2026) links medical device establishment approval with the clearance service; the Release of Medical Devices and Supplies service requires inclusion of all equipment and supplies in the department database, a commercial/purchase invoice, adherence to manufacturer transport/storage conditions, and an undertaking (service period: one working day, fee 5).
Release service details from res-om-release-service.
Local medical device establishments need MoH facility approval; store/warehouse requirements include temperature/humidity monitoring, municipal wholesale license, separate receiving/dispatch/storage and quarantine areas, no storage in apartments, MDCD approvals, and a digital inventory system recording batch numbers ensuring traceability from receipt to distribution; ownership must be Omani (owner/partner of Omani nationality, no partner in more than one pharmaceutical institution).
Same conditions published as 'Storage Requirements for Medical Device and Supplies' PDF (res-om-storage).
Selling medical devices and supplies requires the activity in the commercial registry, activated via a DSC service (1-2 working days, no fee) in adherence to MD 113/2020; per Circular 173/2025 all establishments importing medical devices had to comply with registering in the MoH portal before 01-09-2025.
Circular 173/2025 deadline quoted in the DSC regulation-updates presentation (res-om-md-updates).
Which label and IFU elements, languages, symbols, and translation controls apply?
Manufacturers may supply IFU electronically instead of paper for devices marketed in Oman intended for professional use, subject to: physical label indicating e-IFU and how to access it (URL), e-IFU identical to the paper version, paper IFU provided on request without undue delay or cost, prior versions kept on the website, availability retained 15 years after last manufacture (no expiry date/implantables) or at least 2 years after expiry date for other devices.
References SFDA MDS-G41 (2019) and IMDRF N52 labeling principles.
e-IFU language should be available in Arabic and English; storage requirements additionally require all products to include labelling in English or Arabic if intended for home use.
Home-use labelling quoted in the storage requirements document and the facility approval service page.
Which current law, regulation, guidance, and transition provisions apply?
DSC publishes the device guidance suite: GD1 (Medical Device Listing), GD3 (Class C&D medical devices registration), GD5 (Class C&D IVD registration), GD-22 (manufacturer registration), GD 14 (bundling/grouping criteria), GD 23 (electronic IFU) and Medical Device Reporting guidance (July 2026), plus circulars 126/161/162/173 of 2025.
Guideline PDF URLs were pulled directly from the DSC page HTML and each cited PDF was opened.
Royal Decree No. 35/2015 (Law on Regulating the Pharmacy Profession and Pharmaceutical Establishments) and Ministerial Decree No. 113/2020 issuing its Executive Regulation including the medical device bylaws chapter; device regulation is enforced under MD 113/2020.
Same statement appears in GD-22 and GD3 Chapter One.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Medical device manufacturers must prepare a periodic safety update report (PSUR) for each device (and where relevant per category/group) summarizing post-market surveillance results with preventive/corrective actions; throughout the device lifetime it must set out benefit-risk conclusions, PMCF main findings, sales volume and user population estimates; Class C&D manufacturers update the PSUR at least annually.
Which current form, portal, account, and submission package must be used?
Device adverse events/complaints are reported using the Medical Device Reporting Form (published at moh.gov.om/media/pbybg2yj/medical-device-reporting-form-15072026_1.pdf) to the Medical Device Vigilance Section at vigilance-md@moh.gov.om; general device queries: med-device@moh.gov.om.
All device services (registration, re-registration, manufacturer registration, variation, import of unregistered devices, release, activation) are submitted online through the MoH E-Health portal; GD-22 instructs applying through the online portal and documenting all dossier sections in the online platform.
Circular No. 22 of 2026 (04/03/2026) invited stakeholders to a training workshop on the Taawon 2.0 system for medical device registration, indicating the current registration platform.
Circular body not opened (PDF behind listing); title verified on the official circulars page.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Manufacturer registration requires the quality management system used and its certificates (e.g. ISO 13485) with certificate number and expiry date, plus attachments: QMS certificate, recent audit report, manufacturing/production process, manufacturer layout, commerce agency certificate and agreement with sub-contract manufacturers (sub-sites need the same).
Which recall, FSCA, notice, and authority-coordination duties apply?
FSCA is defined as an action taken by the manufacturer to limit or reduce the risks compromising the safety of a medical device or supply; the Medical Device Vigilance Section evaluates corrective/preventive actions and the Medical Devices Control Department issues Field Safety Notices and alerts or recalls related to medical devices and coordinates action across departments.
Alerts/recalls coordination role stated in the DSC communication guideline (res-om-comm-guideline).
Which registration, notification, listing, reliance, or conformity route applies?
Device registration runs through the MoH E-Health portal service 'Register Medical Device' (service period 60 working days) with class-based fees (A-B: 100; C-D: 200, Omani Rial per gov.om); DSC separately publishes device, manufacturer, e-IFU, reporting, import and variation services/guidance.
Fee currency confirmed as Omani Rial on gov.om national portal page for the same service.
Devices may be registered as Single, Family, System or Procedure Pack; a single registration application may include a maximum of 50 products; accessories may be included with the device unless marketed separately, and separately-marketed members require another application.
GD14 guideline sets the detailed criteria for each grouping type.
Circular No. 161/2025 (published 6 July 2025) commenced registration of high-risk (Class C&D) medical device and supplies manufacturers and their products; Class D device importation is subject to their registration by 01-07-2026. On 28/06/2026 DSC published a circular titled 'Extension of Registration Period for High-Risk Medical Devices and Supplies Manufacturers and Their Products' extending that period (new end date is in a scanned PDF whose text is not machine-readable).
Effective from 2026-07-01
Circular page res-om-cir161 (06/07/2025) and extension circular page res-om-cir-ext (28/06/2026) were opened; both PDFs are scanned images.
GD1 establishes medical device listing: parties supply device identification information to the regulator, submitting all necessary information when the device is first supplied to the market; listing does not remove other regulatory obligations.
Abstracted from GHTF/SG1/N065:2010 per the document's reference section.
Before registering a medical device the applicant must hold: local medical device establishment approval, medical device manufacturer registration, a copy of the Medical Devices Manufacturer License, and a local agency certificate; GD3 also requires initial approval of wholesale activity. Required document: copy of the commercial agency certificate.
GD3 Chapter Two states the same prerequisites.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
Regulatory reference
IFDA's Medical Equipment Directorate has signed cooperation MOUs on mutual recognition of the registration process for drugs and medical/laboratory equipment with Oman and Qatar, and a mutual-registration cooperation MOU with Syria (announced by the directorate's Export Office).
Regulatory reference
IFDA's Medical Equipment Directorate has signed cooperation MOUs on mutual recognition of the registration process for drugs and medical/laboratory equipment with Oman and Qatar, and a mutual-registration cooperation MOU with Syria (announced by the directorate's Export Office).
Regulatory reference
Product verification/validation section accepts the origin-jurisdiction certificate: for EU-route devices CE/EC certificate, full quality assurance or design examination certificate (Class D adds TSE-free certificate if biological); for US-route devices 510(k) or PMA (Class D adds AATB certificate if from US and biological).
GD5 mirrors this for IVDs (CE certificate, Full/Production Quality Assurance, Type Examination; US route PMA/510K).
Prior approval / evidence record
CE Mark (EU MDR)
Yes
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
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
Regulatory reference
The registration dossier must include a free sale certificate from the competent authority in the origin country, or a Certificate of Foreign Government (CFG) if the product is from the USA, or CDNE (certificate for medical device not exported from the United States), plus a list of countries where the device is marketed.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Accepted for the same document slot as a CE certificate, with no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
oman
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
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
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).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
DSC operates an 'Import Unregistered Medical Devices' service issuing permits to import non-registered medical devices for the private market and government hospitals: 30 working days, no fee, conditions are an active related medical device activity in the commercial registry and local medical device establishment approval.
DSC department page describes it as a permit 'for the Private Market and Government Hospitals'.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Medical-device registration applications are filed through the online portal, and the applicant must first complete the initial approval of wholesale activity, local establishment approval and manufacturer registration, with the fee paid according to risk classification. An application made with the incorrect risk classification of a device may result in the re-submission of the application under the appropriate risk class. The Drug Safety Center has the right to request more requirements according to the product type if needed, and a variation in a registered device must be filed through the variation services after registration is completed.
Source is the Drug Safety Center's own registration guideline (DSC/MDC/GUD/003/Vers.01, October 2025), in English, published on the Ministry of Health site; quoted verbatim. This is the guideline's own deficiency and re-submission mechanism: it is the only corrective mechanism stated for a device registration application, and it is what the D25 dimension can be closed on. See the unresolved note for what the same instrument does not provide.
Which UDI, device listing, database, and traceability duties apply?
Medical device manufacturers, authorised representatives, importers and distributors may be subject to listing requirements; a listing party may contract another party to complete the listing on its behalf while retaining responsibility.
The device information section of the dossier must include method of traceability, GMDN nomenclature code, HS code, manufacturer device ID, serial/model number and batch/lot reference for accessories; wholesale stores must operate a digital inventory system with batch-level traceability from receipt to distribution, with separate classification for recalled, damaged and expired products.
Inventory duty quoted in storage requirements document.
What is reportable, by whom, where, in what format, and by what deadline?
Investigation must be concluded and the final report submitted to the Medical Device Vigilance Section within 15 days (no testing/technical evaluation needed), 30 days (device tested inside Oman), or 90 days (device tested outside Oman) from occurrence or awareness.
Calendar days per the guidance wording ('days').
Initial adverse event/complaint reports to the Medical Device Vigilance Section: within 2 working days for events posing a serious threat to public health; within 10 working days for unexpected death or serious unexpected injury; within 30 working days for all other events.
Under Decision 113/2020 Article 90, users of medical devices must inform the Drug Safety Center about any adverse events/complaints related to the use of medical devices within a period from their occurrence according to severity level; reports are received by the Medical Device Vigilance Section.
oman:medical-device
oman
GHTF-style risk classes A through D set by MoH Circular 182/2021.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
Ministry of Health
official-source-verified
Oman MoH Circular No. 182/2021 — Risk Classification of Medical Device
https://www.moh.gov.om/media/1feofpzm/md-regulation-circulars-updates-in-oman.pdf
2026-08-25
Oman
oman
OM
🇴🇲
Oman Ministry of Health
Ministry of Health
middle-east
3
4-class (A, B, C, D) — GCC-aligned
device-registration
Medical-device registration service
MoH registration
60
60
working-days
3
5
months
Yes
official-verified
Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
2026-08-30
manufacturer-registration
Medical-device manufacturer registration
MoH manufacturer registration
60
60
working-days
3
5
months
Yes
official-verified
Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
2026-08-30
device-re-registration
Medical-device re-registration
MoH re-registration
60
60
working-days
3
5
months
Yes
official-verified
Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-re-registration-of-medical-device
2026-08-30
unregistered-device-import
Import authorisation for a non-registered device
MoH import authorisation
30
30
working-days
1.5
3
months
No
official-verified
Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
2026-08-30
product-classification
Product classification ruling
MoH classification
30
30
working-days
1.5
3
months
No
official-verified
Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/apply-for-product-classification
2026-08-30
CE Mark (EU MDR)
Yes
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)/PMA
Yes
Accepted for the same document slot as a CE certificate, with no published reduction.
None published
Yes
Omani Authorized Representative
No
Not accepted
5 years for the device and for a non-local manufacturer registration; 3 years for a local manufacturer registration
2026-08-30
official-verified
Oman MoH Drug Safety Center — Register Medical Device: service completion period 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
2026-08-30
Oman MoH Drug Safety Center — Registration of Medical Device Manufacturer: 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
2026-08-30
Oman MoH Drug Safety Center — Re-registration of Medical Device: 60 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-re-registration-of-medical-device
2026-08-30
Oman MoH Drug Safety Center — Import of Non-Registered Medical Device: 30 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
2026-08-30
Oman MoH Drug Safety Center — Apply for Product Classification: 30 working days
https://moh.gov.om/en/services/businesses/drug-safety-center/apply-for-product-classification
2026-08-30
Oman MoH Drug Safety Center — Clearance / Release of Medical Devices and Supplies: one working day
https://moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
2026-08-30
Oman MoH Drug Safety Center — Request for Medical Device Variation: service completion period published blank (Ministerial Decision 113/2020)
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Omani Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
60 working days
⚙️
5
Registration Approval
Upon successful review, Ministry of Health issues Oman market authorization certificate.
1-2 weeks
✅
oman
Oman
OM
Ministry of Health
100
100
OMR
Yes
200
200
OMR
Yes
device-registration-class-a-b
Device registration - Class A/B
OMR
100
OMR 100
Per registration
Re-registration carries the same fee.
exact-current
official-verified
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Oman MoH: request for registration of a medical device (fees)
2026-08-25
device-registration-class-c-d
Device registration - Class C/D
OMR
200
OMR 200
Per registration
Re-registration carries the same fee.
exact-current
official-verified
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
Oman MoH: request for registration of a medical device (fees)
2026-08-25
manufacturer-registration-non-local
Manufacturer registration - non-local manufacturer
OMR
500
OMR 500
Per registration (5 years)
exact-current
official-verified
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Oman MoH: registration of a medical-device manufacturer (fees)
2026-08-25
manufacturer-registration-local
Manufacturer registration - local manufacturer
OMR
1500
OMR 1,500
Per registration (3 years)
exact-current
official-verified
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
Oman MoH: registration of a medical-device manufacturer (fees)
2026-08-25
device-variation
Medical device variation
OMR
25
OMR 25
Per variation
exact-current
official-verified
https://www.moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
Oman MoH: medical-device variation request (fee)
2026-08-25
customs-clearance
Release/customs clearance of medical devices and supplies
OMR
5
OMR 5
Per consignment
exact-current
official-verified
https://www.moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
Oman MoH: clearance/release of medical devices and supplies (fee)
2026-08-25
2026-08-25
official-verified
Oman MoH: request for registration of a medical device (fees)
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device
2026-08-25
Oman MoH: registration of a medical-device manufacturer (fees)
https://moh.gov.om/en/services/businesses/drug-safety-center/request-for-registration-of-medical-device-manufacturer
2026-08-25
Oman MoH: medical-device variation request (fee)
https://www.moh.gov.om/en/services/businesses/drug-safety-center/request-for-medical-device-variation
2026-08-25
Oman MoH: clearance/release of medical devices and supplies (fee)
https://www.moh.gov.om/en/services/businesses/drug-safety-center/clearance-release-of-medical-devices-and-supplies
2026-08-25
Oman MoH: import permit for non-registered medical devices (no fee)
https://www.moh.gov.om/en/services/businesses/drug-safety-center/application-for-import-of-non-registered-medical-device
2026-08-25
2026-08-25
exact-current
Yes
oman
Oman
low
moh-manufacturer-registration-iso-13485
MoH manufacturer registration ISO 13485
Medical Electrical Safety
Mandatory Pre Market
Manufacturer Site
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.
reviewed
reference-jurisdiction-certificates
Reference-jurisdiction certificates (CE/510(k)/PMA)
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
reviewed
Oman Ministry of Health
GD-22 manufacturer registration — ISO 13485 certificate and audit report
https://www.moh.gov.om/media/ubmn0pgh/guidance-document-gd-22-guideline-on-requirements-of-medical-device-manufacturer-registration-in-sultanate-of-oman.pdf
Oman Ministry of Health
GD-3 class C/D registration — CE/510(k)/PMA evidence and testing overlays
https://www.moh.gov.om/media/ov3mnntj/guidance-document-gd3-guideline-on-requirements-of-class-c-d-medical-devices-registration.pdf
