Explore the medical device requirements currently available for Qatar, organized by topic and linked to official sources.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical trials in Qatar may only be conducted through a licensed research institution, and a licence from the Ministry of Public Health's competent administrative unit (الإدارة), based on the approval of the National Committee for the Ethics of Health Research, is required for any of the following: a clinical trial of a medical product not registered in the State; a clinical trial of a medical product registered in the State that is examined in a manner inconsistent with the registered standards, for example through a new route or dose; a clinical trial of a combination of registered pharmaceutical preparations; and a medical procedure not used in the health facility in which the trial is conducted. Being granted the status of principal investigator for those trials likewise requires a licence from the Administration on the National Committee's approval, and health research generally may not be conducted except through a research institution and after the approval of one or more human, animal or laboratory research review committees.
Effective from 2025-04-13
Arabic-language source; the excerpt is given in Arabic with an English translation. Read in full from Al Meezan on 2026-09-16. Articles 12 and 13 quoted verbatim; Article 4 (health research only through a research institution and with research-review-committee approval) and Article 14 (conditions for principal-investigator status: a licensed human or dental physician in the State, the scientific qualifications and experience set by the regulation, registration with a licensed research institution, and no final conviction for an offence against honour or trust) were also read in full. Article 32(3)(ت) and 32(3)(ث) confirm that the National Committee approves the grant and renewal of clinical-trial licences and principal-investigator status. The supporting source is the MoPH organisational instrument cited in Law No. 6 of 2025's own preamble; it is used only to evidence the Ministry's identity as the issuing authority, since it contains no device rule of its own.
Is the product a device, IVD, accessory, software, or borderline product locally?
Qatar's Law No. 6 of 2025 on the regulation of health research defines a 'medical product' (المنتج الطبي) as any device, medicine, biological product or other thing used to diagnose, prevent or treat diseases, and its definition of 'clinical trials' (التجارب السريرية) expressly names medical devices (الأجهزة الطبية) among the interventions a trial may evaluate, alongside medicines, experimental gene and stem-cell therapy, behavioural therapies, and changes to the care process and preventive care.
Effective from 2025-04-13
Arabic-language source; the excerpt is given in Arabic with an English translation, per the bilingual-source rule. Read in full from Al Meezan on 2026-09-16 (159,204 bytes). The whole law was searched for the device terms الأجهزة الطبية / الأجهزة والمستلزمات الطبية / المنتجات الطبية: they occur only in the Article 1 definition of التجارب السريرية and, functionally, in Articles 12 and 13 (see clinical.trial-licence-unregistered-medical-product). No other article of the law defines or regulates a device as such.
Which evidence, local deltas, formats, and signatures are required?
All documents submitted with the IMD registration application must be valid for a minimum of 6 months from the date of submission.
IMD registration requires a Free Sale Certificate (FSC) for the device from the country of origin.
IMD registration requires a laboratory analysis report and a safety data sheet as checklist documents.
IMD registration requires the registration certificate of the manufacturer(s) as a checklist document.
IMD registration requires product information (Finished Product Specifications) including description, design, sizes, models, accessories, uses, side-effects, warnings, precautions, brochures, and manuals; multiple models/sizes are listed in a separate excel sheet attached to the form.
Where applicable, the IMD application must include description and technical details of accessories/kits needed to implant or manage the IMD, and any specialized training/certification needed by clinical professionals plus certification for the local representative providing clinical and technical assistance.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Manufacturer registration certificate is a separate checklist item (item 1).
IMD registration requires an authorization letter or contract from the manufacturer for the local agent, with clear details of service validity and responsibilities.
Which establishment licences, importer permissions, and distribution controls apply?
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 or handwritten applications are not accepted.
Service is offline (paper form at MoPH counter).
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 permits and approvals for products requiring approval.
Contact given: inspection&narcotic@moph.gov.qa; Pharmacy Department.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
IMD registration requires a post-marketing surveillance plan for local implementation as a checklist document.
Which current form, portal, account, and submission package must be used?
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 requests receive an official MoPH access-denied page referencing soc@moph.gov.qa).
imdr.moph.gov.qa was opened directly and returned the MoPH access-denied page only.
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) Registration Portal at imdr.moph.gov.qa (login-gated; external access returns an official MoPH access-denied page).
Baseline fact confirmed; form and checklist fully opened and quoted.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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 and filling an application form submitted to MoPH; no fee is charged.
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 FDA/CE certificate or equivalent approval, a certified copy of the certificate of origin, and a catalog or technical brochure; the facility must be licensed; fee is based on the type of healthcare facility; published delivery time 6 days and 1 working hour.
Contact: facilitieslicensing@moph.gov.qa.
Which registration, notification, listing, reliance, or conformity route applies?
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 online portal (imdr.moph.gov.qa, access-restricted externally). This fact is limited to that verified IMD route and does not characterize the route for other devices.
Baseline fact confirmed and strengthened: form and checklist fully opened; portal existence verified via DHP page link.
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-related services are facility device licensing, equipment safety assessment/technical evaluation, and customs-port shipment inspection.
Consultant pages describe a per-shipment PDCD import permit for non-implantable devices, but no official MoPH page could be opened stating this.
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
IMD registration requires notarized CE or FDA certificates from the country of origin listing the reference numbers of the devices being registered.
Regulatory reference
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.
Regulatory reference
For implantable medical device registration, MoPH's application checklist requires notarized CE or FDA certificates covering the devices; it enumerates only CE and FDA and offers no 'other reference authority' option. A China NMPA registration certificate is therefore not an accepted conformity credential for IMD registration in Qatar.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
qatar
Implantable medical devices (IMD) of any NMPA class; MoPH IMD registration is the only product-registration route Qatar operates for devices
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: 6. Notarized CE or FDA certificates from the country of origin with reference numbers of the devices for registration.
Prior approval / evidence record
The IMD registration checklist separately requires a Free Sale Certificate for the device from the country of origin. For a China-made implant this would be NMPA-based free-sale evidence, but it is a supplementary document that does not replace the CE/FDA certificate requirement or trigger any abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
qatar
Implantable medical devices (any NMPA class)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Source passage: 7. Free Sale Certificate (FSC) for the device from the country of origin.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Under Qatar's Law No. 6 of 2025 a licence application, or an application to renew one, is filed with the Ministry of Public Health's competent administrative unit (الإدارة) on the form prescribed for that purpose with the supporting documents; the Administration must decide the application within thirty days of submission and notify the applicant at its national address or by any means that gives knowledge. A refusal must be reasoned, and expiry of the thirty days without a reply is an implicit refusal of the application. The applicant may then appeal (يتظلم) to the Minister of Public Health within thirty days of being notified of the refusal; the Minister must decide the appeal within thirty days of its submission; expiry of that period without a reply is an implicit refusal of the appeal; and the Minister's decision on the appeal is final. The same procedure and the same time limits apply to applications for the licences under Articles 10, 12 and 13 of the law and to appeals against the administrative sanctions imposed under Article 35.
Effective from 2025-04-13
Arabic-language source; the excerpt is given in Arabic with an English translation. Read in full from Al Meezan on 2026-09-16. The three passages quoted in the excerpt are verbatim and non-contiguous; the ellipsis marks the gaps. Article 8's first three paragraphs (application on the prescribed form; thirty-day decision clock with notification at the national address or by any means that gives knowledge; reasoned refusal and implicit refusal on expiry) were also read in full and are paraphrased in `value`.
What is reportable, by whom, where, in what format, and by what deadline?
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 against a registered IMD, the manufacturer will inform the IMD Committee within 2 weeks.
No maintained record.
No maintained record.
No maintained record.
qatar
Qatar
low
moph-imd-registration-evidence
MoPH IMD registration evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
IMD registration application checklist items 10-11: a laboratory analysis report and safety data sheet are mandatory documents; notarized CE or FDA certificates and a certificate of origin accompany the registration.
candidate
radiation-certificate-for-facility-equipment
Radiation certificate for facility equipment
Ionizing Radiation
Mandatory For Use Site
Radiation Equipment In Facility
Equipment-safety assessment requires a copy of the Radiation Certificate when radiation equipment is used; the facility technical evaluation also requires an original FDA/CE certification or an equivalent approval.
unresolved
MoPH Qatar
IMD registration application — laboratory analysis report and safety data sheet
https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=%2FAdmin%2FLists%2FAnnouncements%20Attachments%2FAttachments%2F97%2FIMD%20Registration%20Application%20Form.pdf
Hukoomi (Qatar)
medical equipment safety assessment — radiation certificate requirement
https://hukoomi.gov.qa/en/services/request-assessment-of-safety-of-medical-equipment-and-devices
Sharek (Qatar)
facility technical evaluation — original FDA/CE certification or equivalent
https://www.sharek.gov.qa/en/articles/ministry-of-public-health/technical-evaluation-for-the-safe-use-of-medical-equipment-in-a-healthcare-facility/679b20d022938a05a01e5525
