Qatar medical device registration resources

Competent authority

Ministry of Public Health (MoPH) of Qatar is the competent authority; requests concerning medical devices and equipment in healthcare facilities are submitted to its Facilities Licensing an…

Implanted Medical Devices (IMD) Committee

An 'IMD Committee' is the MoPH body referenced by the official implantable medical device registration application; manufacturers must report certain events to it.

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Market-access route or official registration surface

MoPH operates an implantable medical device (IMD) registration route: an official application form with document checklist plus a dedicated Implanted Medical Devices Registration page and o…

No published registration service for non-implantable devices

The official MoPH service catalog (Sharek, 10 pages, ~100 services) contains no product registration, listing, or import permit service for non implantable medical devices; the only device…

CE or FDA certificates accepted for IMD registration

IMD registration requires notarized CE or FDA certificates from the country of origin listing the reference numbers of the devices being registered.

FDA/CE or equivalent approval accepted for equipment evaluation

For MoPH technical evaluation of medical equipment in a healthcare facility, each device must be supported by an original FDA/CE certification or an equivalent approval.

Local agent authorization requirement

IMD registration requires an authorization letter or contract from the manufacturer for the local agent, with clear details of service validity and responsibilities.

Applicant is a licensed healthcare facility

The IMD registration applicant is a healthcare facility: the form captures Facility Name and License No., and the checklist requires the registration certificate of the applicant facility.

Inspection of medical shipments at customs ports

MoPH inspects pharmaceutical or medical shipments arriving in Qatar through all customs ports and takes the appropriate action; the request must include, among other documents, import permi…

Medical device license within healthcare facility

A license from MoPH is required for medical devices and equipment within a healthcare facility: a paper form submitted at MoPH (8:00 12:00), with attachments; no fee is charged; incomplete…

Free Sale Certificate required

IMD registration requires a Free Sale Certificate (FSC) for the device from the country of origin.

Manufacturer registration certificate required

IMD registration requires the registration certificate of the manufacturer(s) as a checklist document.

Official form or portal surface

Official surfaces: the MoPH Implantable Medical Device Registration Application form with Application Documents Checklist (PDF on moph.gov.qa) and the Implanted Medical Device (IMD) Registr…

IMD Registration Portal

The Department of Healthcare Professions website links the 'Implanted Medical Device (IMD) Registration Portal' at imdr.moph.gov.qa; the portal itself is access restricted (external request…

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Technical evaluation of medical equipment

MoPH conducts a technical evaluation for the safe use of medical equipment within a healthcare facility (new facilities or existing facilities adding equipment): per device it requires the…

Assessment of safety of medical equipment and devices

Healthcare investors may request the MoPH Health Facilities Licensing and Accreditation Department to conduct an assessment of the safety of medical equipment and devices, by downloading an…

MoPH IMD registration evidence

Electrical safety

Radiation certificate for facility equipment

Radiation

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Manufacturer support on local-agent termination

IMD registration includes a manufacturer declaration that, in case of termination of the local agent or the local agent being unable to serve, the manufacturer will provide direct support.

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Post-marketing surveillance plan for local implementation

IMD registration requires a post marketing surveillance plan for local implementation as a checklist document.

Notify IMD Committee within 2 weeks of bans or proceedings

The manufacturer must declare that the IMD proposed for registration is not facing legal proceedings, bans or suspended use in any country, and undertake that, if any such proceedings arise…

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

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