Oman medical device regulatory resources

Competent authority

Drug Safety Center (DSC), Ministry of Health, regulates medicines, medical devices and supplies in Oman; its Medical Devices Control Department has four sections: Medical Device Registratio…

Current device guidance suite

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…

Primary legal basis

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 med…

IVD definition

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/pathologi…

Medical device definition

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…

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

Class A, Class B, Class C, Class D

Market-access route (official registration surface)

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)…

Grouping/bundling in one application

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 un…

Foreign marketing-authorization evidence

Product verification/validation section accepts the origin jurisdiction certificate: for EU route devices CE/EC certificate, full quality assurance or design examination certificate (Class…

Free sale / foreign government certificate

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…

Local agent requirement

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 l…

Manufacturer registration obligation

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 l…

Clearance linked to establishment approval (Circular 15/2026)

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 eq…

Local establishment approval and storage requirements

Local medical device establishments need MoH facility approval; store/warehouse requirements include temperature/humidity monitoring, municipal wholesale license, separate receiving/dispatc…

Class C&D IVD dossier sections

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; Se…

Class C&D medical device dossier sections

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, prod…

Adverse event reporting form and channel

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 De…

Online submission portal

All device services (registration, re registration, manufacturer registration, variation, import of unregistered devices, release, activation) are submitted online through the MoH E Health…

Electronic IFU permitted

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 (UR…

Label/IFU language

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.

QMS/ISO 13485 requirement

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, recen…

MoH manufacturer registration ISO 13485

Electrical safety

Reference-jurisdiction certificates (CE/510(k)/PMA)

Electrical safety

Device registration - Class A/B

OMR 100

Device registration - Class C/D

OMR 200

Medical-device registration service · MoH registration

60 working days

Medical-device manufacturer registration · MoH manufacturer registration

60 working days

Medical-device re-registration · MoH re-registration

60 working days

Device re-registration

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 certi…

Manufacturer registration term

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…

Post-registration variations

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…

Listing parties

Medical device manufacturers, authorised representatives, importers and distributors may be subject to listing requirements; a listing party may contract another party to complete the listi…

Traceability data in registration

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 a…

Performance evidence (IVDs)

IVD Class C&D registration requires clinical performance and analytical performance documentation plus stability testing, shelf life testing and software validation.

Clinical evidence (medical devices)

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 su…

Import of unregistered devices permit

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 f…

PSUR obligation

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 pr…

Final report deadlines

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…

Initial report deadlines

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 unexpe…

FSCA and market surveillance role

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 cor…

No source-verified answer is published for this dimension yet.

Corrective re-submission on incorrect risk classification and the authority's right to request more requirements

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…