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United Arab Emirates medical device regulations

Official sources linked

EDE rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

23 documents4 categories100% linked to official sourcesauthority EDE15 readable HTML
CodeRegulationCategoryEffectiveProvenance
Federal Decree-Law No. 38 of 2024
Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
Primary law for medical products, including Medical Equipment, in force from 2 January 2025. It assigns marketing approval and oversight functions to EDE alongside responsibilities of the Ministry and competent health authorities, and repeals Federal Law No. 8 of 2019 subject to the transition in Article 180. The complete official English expression includes the preamble, nine Parts, twelve Chapters and 181 articles. The Arabic original prevails in interpretation and application.
General2025-01-02Official
Classification Guidelines
Classification of a Product - Guidelines
MOHAP service guideline for the classification-of-a-product service, which determines whether a product requires MOHAP registration and in which class (UAE uses Classes I-IV). Covers the classification-letter terms (validity three years, not a registration certificate), device-specific conditions in items 11.1-11.10 (accessory lists, grouping, laboratory reagents, professional-restricted clearance, software processing patient data), letter formats, and the twelve required documents (country-of-origin certificates, product catalogue for medical devices, artworks, MSDS). After the transfer of medical-product services to the Emirates Drug Establishment the official copy is served by the EDE document portal (title carries the official typo "GUIDLINES"); the original mohap.gov.ae host resets TLS connections from our verification egress and is unreachable. Ingested in full.
Classification2024Official
Device Classification
Classification of a Product
Product classification service to determine if registration by MOHAP is required. UAE uses 4-class system (Class I, II, III, IV). Higher risk devices require additional documentation.
Classification2021Official
Medical Equipment Registration
Registration of Medical Equipment
Registration service for medical equipment for import and trading in UAE. Requires valid licensed medical warehouse or marketing office. Registration fee: AED 5,000.
Registration2021Official
Facility Licensing
Licensing of a Pharmaceutical/Medical Device Manufacturing Facility
Licensing for pharmaceutical and medical device manufacturing facilities. License fee: AED 50,000. Biomedical engineer may replace pharmacist for medical device-only facilities.
GMP/QMS2021Official
Import Permit
Issue of Permit to Import Medical Equipment
Import permit for local agents with valid medical store license. FANR permit required for ionizing radiation devices. Batch Release Certificate required for blood/plasma/tissue products.
Registration2021Official
Manufacturer Site Registration
Registration of a Manufacturer of Medical Products
Registration of manufacturing sites for medical products. Requires valid ISO 13485 certificate and business/manufacturing license from country of origin. Renewal every 5 years.
Registration2021Official
Registration Renewal
Renewal of Registration of Medical Equipment
Procedures for renewing medical equipment registration. Registration must be renewed before expiration to maintain market authorization.
Registration2021Official
Registered Medical Devices Database
MOHAP Registered Medical Devices Database
Public database of medical devices registered with MOHAP. Searchable by product name, manufacturer, or registration number.
Registration2020Official
Federal Law No. 8 of 2019
Federal Law Regarding Medical Products, the Pharmacy Profession and Pharmaceutical Establishments
Primary federal law governing medical products including medical devices in the UAE (2019). REPEALED by Federal Decree-Law No. 38 of 2024 (Article 180), which entered into force 2 January 2025 — see the successor row. This is a real binding instrument, not a non-document page; it is source-blocked because the stored MOHAP URL points to Cabinet Resolution No. 90 of 2021 rather than the law itself and mohap.gov.ae resets TLS connections from verification egress. The repeal is evidenced by Article 180 of the successor Decree-Law on the official UAE legislation portal and by the EDE legislations register, which no longer lists Law 8/2019 among the laws in force.
General2019Official
قرار مجلس الوزراء رقم (155) لسنة 2026
قرار مجلس الوزراء رقم (155) لسنة 2026 بشأن إعفاء بعض المنتجات الطبية من شرط الحصول على الموافقة التسويقية لتداولها
Complete captured official Arabic HTML expression: title, preamble and all five articles. Source is a Firecrawl-rendered snapshot of the official legislation portal, not direct HTTP/PDF bytes. Article 2 expressly includes medical devices and healthcare products classified by EDE as not requiring marketing authorization; all exemptions remain conditional. Article 4 retains other applicable legal duties. The publisher’s Article 3 cross-reference to Article 1 and the portal’s inconsistent commencement/publication observations are retained, not corrected. No juridical MA-ownership-transfer conditions, blanket device exemption, IVD classification or current-law completeness inferred; official PDF not acquired.
Registration—Official
Cabinet Resolution No. 40 of 2025
Cabinet Resolution No. (40) of 2025 — Service Fees Provided by the Emirates Drug Establishment
Complete original source PDF retained unchanged; every physical page image is mandatory and authoritative. Native PDF text is supplied only as explicitly incomplete search text and may omit screenshot words or contain original extraction artifacts. The complete 36-page English expression includes Schedules 1/2. Shared medical-product fees contain device-related items and unrelated sector rows; other-sectorrows arecontext, notdevice law. Original Arabic text prevails. No blanket 2026 current-rate or eligibility claim.
Registration—Official
Cabinet Resolution No.90 of2021
قرار مجلس الوزراء رقم (90) لسنة 2021 بشأن اللائحة التنفيذية للقانون الاتحادي رقم (8) لسنة 2019 في شأن المنتجات الطبية ومهنة الصيدلة والمنشآت الصيدلانية
Complete33-page official Arabic expression of Cabinet Resolution90/2021 under former Federal Law8/2019, retaining all40articles and both original annexes. Article33(4), physical16, expressly names medical devices in the holder/local representative supply undertaking. Drug/pharmacy-only sections and personal-use/warehouse annexes are context and are not generalized to device or IVD duties. Article17 on physical8 concerns pharmaceutical-establishment ownership, not medical-product marketing-approval ownership. This original does not close the outstanding Decree-Law38/2024 Article17(2) implementing-conditions gap. Every original page image is mandatory; native text is an incomplete search layer with glyph/replacement artifacts. Current applicability and later amendments remain unverified. Conflicting portal commencement metadata is not used to assign an effective date.
Registration—Official
EDE medical-device marketing authorization user guide
External User Guide — Issuance of Marketing Authorization for a Medical Device
Complete original source PDF retained unchanged; every physical page image is mandatory and authoritative. Native PDF text is supplied only as explicitly incomplete search text and may omit screenshot words or contain original extraction artifacts. The complete captured PDF has 63 physical pages with printed labels 2–22 then 25–65; printed 23/24 are absent in thisexpression and not invented. Mixed registration/minor-variation/screens/applicant-response clocks are retained; no universal device-change route or product-MA ownership-transfer conditions inferred.
Registration—Official
Renewal of Marketing Authorization for a Medical Device
Renewal of Marketing Authorization for a Medical Device
Complete captured official service root: title, service conditions/process/documents, all FAQs where present, duration/fees, support, audience, payment, resources and related-service words retained. Only exact Start Service/expand-collapse UI and separately retrieved, actually viewed symbol-only SVG icons excluded through source-bound proof. Device renewal service with original reagent/document wording. Its fee label says general-sale pharmaceutical product and a workflow step is duplicated; both publisher artifacts retained without repair or generic fee applicability inference.
Registration—Official
Issuance of Marketing Authorization for a Medical Device
Issuance of Marketing Authorization for a Medical Device
Complete captured official service root: title, service conditions/process/documents, all FAQs where present, duration/fees, support, audience, payment, resources and related-service words retained. Only exact Start Service/expand-collapse UI and separately retrieved, actually viewed symbol-only SVG icons excluded through source-bound proof. Complete device-MA public service card. Mixed pharmaceutical template wording and duplicated published fees are retained. No universal change route inferred.
Registration—Official
Certificate of Amendment of Manufacturer’s Data for Medical Products
Certificate of Amendment of Manufacturer’s Data for Medical Products
Complete captured official service root: title, service conditions/process/documents, all FAQs where present, duration/fees, support, audience, payment, resources and related-service words retained. Only exact Start Service/expand-collapse UI and separately retrieved, actually viewed symbol-only SVG icons excluded through source-bound proof. Company/manufacturer registration-data amendment service, linked in source to device MA registration. Mixed product scope is preserved; not product-MA ownership-transfer eligibility.
Registration—Official
EDE manufacturer-information amendment user guide
External User Guide — Certificate of Amendment of Manufacturer’s Information for Medical Products
Complete original source PDF retained unchanged; every physical page image is mandatory and authoritative. Native PDF text is supplied only as explicitly incomplete search text and may omit screenshot words or contain original extraction artifacts. Registration/company/manufacturer information and mixed workflow examples remain scoped. This is not evidence of juridical product-marketing-approval ownership-transfer eligibility or conditions.
Registration—Official
Registration of A Manufacturer of Medical Products
Registration of A Manufacturer of Medical Products
Complete captured official service root: title, service conditions/process/documents, all FAQs where present, duration/fees, support, audience, payment, resources and related-service words retained. Only exact Start Service/expand-collapse UI and separately retrieved, actually viewed symbol-only SVG icons excluded through source-bound proof. Shared manufacturer-site/MAH registration service contains an express medical-device manufacturing-site document section. Keep device section distinct from general GMP and pharmaceutical fields; no device-wide waiver or product-MA transfer inferred.
Registration—Official
EDE medical-product manufacturer registration user guide
External User Guide — Registration of a Manufacturer of Medical Products
Complete33-physical-page English EDE manufacturer-registration guide expression linked from the official service captured26October2026, which expressly has a medical-device manufacturing-site branch. The manual itself names medical-device manufacturers and device fields. It reuses the site-registration body of the manufacturer-information amendment guide; this distinct title/resource/raw expression is not additional legal-rule coverage. Mixed drug/site/MAH examples and conditional GMP/document rules remain scoped; no blanket device GMP requirement, product-MA ownership transfer or universal change route inferred. Full original images are mandatory and native text is an incomplete search layer.
Registration—Official
EDE medical-product marketing-authorization data amendment user guide
External User Guide — Issuance of a Certificate of Amendment to the Registered Marketing Authorization Data for a Medical Product
Complete63-physical-page historical English EDE guide expression, with an unnumbered cover and printed2–22then25–65; printed23/24 are absent in the captured original and are not invented. Its exact official resource/title/raw bytes differ from the device-issuance guide, but it substantially reuses that mixed drug/device workflow; it is not additional legal-rule coverage. Medical-device services are expressly named in the manual and retained official service resource. Drug-only examples, screenshots and applicant clocks remain scoped. Full original images are mandatory; native text is an incomplete search layer. No product-MA ownership-transfer eligibility, Article17(2) implementation, universal deadline or current-law finding.
Registration—Official
شهادة تعديل بيانات الموافقة التسويقية لمنتج الطبي
شهادة تعديل بيانات الموافقة التسويقية لمنتج الطبي
Complete captured official service root: title, service conditions/process/documents, all FAQs where present, duration/fees, support, audience, payment, resources and related-service words retained. Only exact Start Service/expand-collapse UI and separately retrieved, actually viewed symbol-only SVG icons excluded through source-bound proof. Actual Arabic public service expressly lists medical devices among minor-change document categories. Proposed changes and documentation remain conditional on source requirements and referenced applicable guideline. It is not evidence of juridical product-MA ownership-transfer conditions.
Registration—Official
Federal Decree-Law No.38 of 2024
Federal Decree-Law No.38 of 2024 — complete Arabic official expression
Complete eighty-eight-page Arabic official expression of Federal Decree-Law No.38 of 2024 concerning medical products, the pharmacy profession and pharmaceutical establishments, including its original chemical schedule. The instrument contains mixed product and establishment scopes; drug, veterinary and chemical provisions are preserved as source context without being applied to medical devices or IVD. This Arabic original is a separate expression of the same instrument as the held English version, not an alias or a new instrument. The full original images govern over the qualified native search layer. Article 17 alone does not supply the outstanding detailed transfer conditions or checklist; currentness and question coverage remain unverified.
General—Official
Exports carry source + retrieval date

Changes after registration in United Arab Emirates

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Map the actual change to an eligible Article 16 minor-change object. A true different-juridical MA owner also requires Article 17(2); this general minor-change rule does not establish that transfer’s detailed implementation or a fee.
  • Filing route and prior approval

Product amendment submission workflow

Fact-level verified

Search/select the registered product, modify the fields actually open for the product/pack, attach the applicable supporting documents, review/accept terms, proceed through checkout and submit for EDE processing. The resulting minor-variation certificate records approved change details; its multiple-section layout is not permission to group any proposed combination or a new juridical owner into one filing.

Conditions
  • Follow the current service sequence of completing the application, attaching the applicable documents and paying before submission. The guide illustrates product/pack selection, open fields, attachments, terms, checkout and the resulting certificate.
Certificate of amendment to registered medical-product marketing-authorization data — current Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Filing route and prior approval
  • Supporting documents

Expired MA: retain the active-renewal exception

Fact-level verified

The current amendment service rejects minor-variation requests after the MA expires unless a renewal application is active. Submit documents on the company’s official letterhead carrying its name/logo, and evidence of competent origin-country approval of the proposed changes where applicable. The current active-renewal exception qualifies the older guide’s unexpired-product rule; it does not independently authorize continued supply after MA expiry.

Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • The active-renewal acceptance exception concerns request eligibility, not continued supply or old-stock permission.
  • Labels and identifiers

Product information must match the approval

Fact-level verified

The internal and external label and printed or electronic leaflet must match the package information in the marketing-approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

  • Supporting documents

Product-amendment materials and conditional device scope

Fact-level verified

The amendment service lists a company-signed/stamped minor-change application; the relevant change documents under the current applicable guide; the issued valid MA; a valid manufacturing-site registration; outer/inner packaging and leaflet; and, for certain changes, a sample and analysis certificate. Its medical-device branch is explicit. Select device-applicable materials and the actual change category; mixed pharmaceutical attachments such as active-substance or drug-PV materials are not a universal IVD/device checklist.

Conditions
  • The guide describes only two additional uploads in its minor-variation attachment screen; this screen limit does not remove otherwise applicable documentary requirements.
  • Read the current service requirement for a valid MA copy together with its exception accepting a minor-variation request while a renewal application is active; acceptance of the request does not itself authorize continued supply after expiry.
Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Select the medical-device change materials; mixed drug-specific attachments are not automatically a universal device/IVD checklist, and the list does not establish replacement CFS for every change.
  • Change-specific review time

Published duration for the applicable amendment service

Fact-level verified

The current EDE medical-product amendment service publishes 22 working days. Use this only once the proposed change qualifies for that service; it is not the duration of manufacturer-master-data amendment, a new MA, true juridical transfer or the whole preparation/foreign-approval/combined-change project.

Conditions
  • Published duration for the eligible product-MA amendment service only; preparation, foreign approvals, corrections and other service objects are separate.
  • No statutory stop-clock or guaranteed end-to-end completion promise is specified by this service page.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Labels and identifiers

Trade name, MAH, labels and GTIN are separate fields

Fact-level verified

The mixed device-applicable guide lists trade name, MAH/contact/address, manufacturer-related manufacturing-stage/site data, label/artwork attachments and a pack-size GTIN among fields that may be open for minor variation. Only fields actually open may be modified. The catalogue does not equate an internal orderable SMN/REF with model or GTIN/UDI, or establish that editing the MAH name field transfers the MA to a new legal person.

Conditions
  • Confirm the existing registered product/pack identifiers and proposed old-to-new mapping.
  • For an IVD, confirm its EDE device classification and the actual open fields before mapping an orderable REF to a registered product, model or pack identifier.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual open registered product/pack field and old-to-new identifier mapping. An orderable REF is not automatically GTIN/UDI/model, and editing a holder-name field is not an ownership-transfer decision.
  • Existing stock and transition

Expiry or lapse consequence

Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the ordinary-MA expiry/activity restriction; a pending renewal or accepted variation is not the specific EDE permission for continued activity. This does not establish an old-label or old-holder stock grace period.
  • Change-specific government fees

Conditions for this question

  • Only if the actual proposed product change qualifies for EDE’s minor-variation/product MA-data-amendment certificate; not a true legal-owner transfer price or a total covering company/site changes, new MA or a combined project.
  • Only a confirmed eligible product-MA amendment certificate under Annex item 28 (charged each time); this does not price a change of juridical MA owner or an entire combined project.
Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Map the actual change to an eligible Article 16 minor-change object. A true different-juridical MA owner also requires Article 17(2); this general minor-change rule does not establish that transfer’s detailed implementation or a fee.
  • Filing route and prior approval

Product amendment submission workflow

Fact-level verified

Search/select the registered product, modify the fields actually open for the product/pack, attach the applicable supporting documents, review/accept terms, proceed through checkout and submit for EDE processing. The resulting minor-variation certificate records approved change details; its multiple-section layout is not permission to group any proposed combination or a new juridical owner into one filing.

Conditions
  • Follow the current service sequence of completing the application, attaching the applicable documents and paying before submission. The guide illustrates product/pack selection, open fields, attachments, terms, checkout and the resulting certificate.
Certificate of amendment to registered medical-product marketing-authorization data — current Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Filing route and prior approval
  • Supporting documents

Expired MA: retain the active-renewal exception

Fact-level verified

The current amendment service rejects minor-variation requests after the MA expires unless a renewal application is active. Submit documents on the company’s official letterhead carrying its name/logo, and evidence of competent origin-country approval of the proposed changes where applicable. The current active-renewal exception qualifies the older guide’s unexpired-product rule; it does not independently authorize continued supply after MA expiry.

Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • The active-renewal acceptance exception concerns request eligibility, not continued supply or old-stock permission.
  • Filing route and prior approval

Manufacturer/site master data is a separate amendment object

Fact-level verified

If the registered manufacturer/company/site data changes, use the manufacturer-data amendment service for that object as applicable. Its site minor-variation guide requires an unexpired site and permits only certain open fields. Changing that record does not itself amend every product MA or transfer product MA ownership. A same-entity office/name change must first be located in the manufacturer master record and product approval particulars; do not assume a manufacturing-site move.

Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if the registered manufacturer/company/site master record actually changes. This is a separate service object and does not itself amend every product MA, transfer a product MA to a new legal person or prove that a pure office change is a factory relocation.
  • Supporting documents

Product-amendment materials and conditional device scope

Fact-level verified

The amendment service lists a company-signed/stamped minor-change application; the relevant change documents under the current applicable guide; the issued valid MA; a valid manufacturing-site registration; outer/inner packaging and leaflet; and, for certain changes, a sample and analysis certificate. Its medical-device branch is explicit. Select device-applicable materials and the actual change category; mixed pharmaceutical attachments such as active-substance or drug-PV materials are not a universal IVD/device checklist.

Conditions
  • The guide describes only two additional uploads in its minor-variation attachment screen; this screen limit does not remove otherwise applicable documentary requirements.
  • Read the current service requirement for a valid MA copy together with its exception accepting a minor-variation request while a renewal application is active; acceptance of the request does not itself authorize continued supply after expiry.
Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Select the medical-device change materials; mixed drug-specific attachments are not automatically a universal device/IVD checklist, and the list does not establish replacement CFS for every change.
  • Supporting documents

Materials for manufacturer/company-data amendment

Fact-level verified

The manufacturer-data service requires current origin-country authority approval of the requested changes and a signed/stamped letter comparing existing and proposed details. Its published list also includes certified company authorization, current GMP/manufacturing licence materials, product/site documentation and the current EDE registration certificate. Apply the actual device/site conditions; the mixed guide’s initial-registration attachment Y/N markers do not establish a blanket device exemption from this service list.

Conditions
  • This is a manufacturer/company-data service; do not present its documents as the complete true product MA-transfer dossier.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific government fees

Fee for the separate manufacturer/company-data certificate

Fact-level verified

The fee for a certificate modifying registration data of a medical company or factory holding a marketing right is AED 2,000 per certificate under Cabinet 40/2025 Annex item 27, consistent with the current manufacturer-data service. This is a separate object from the product MA amendment certificate in item 28.

Conditions
  • Only if that company/factory-data certificate is actually required; not the total for all proposed product changes or true-MA transfer.
Certificate of amendment of medical-products manufacturer/company registration data — Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific review time

Published duration for the applicable amendment service

Fact-level verified

The current EDE medical-product amendment service publishes 22 working days. Use this only once the proposed change qualifies for that service; it is not the duration of manufacturer-master-data amendment, a new MA, true juridical transfer or the whole preparation/foreign-approval/combined-change project.

Conditions
  • Published duration for the eligible product-MA amendment service only; preparation, foreign approvals, corrections and other service objects are separate.
  • No statutory stop-clock or guaranteed end-to-end completion promise is specified by this service page.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Change-specific review time

Published manufacturer-data amendment duration

Fact-level verified

EDE publishes 10 working days for the manufacturer/company-registration-data amendment service and describes this in its FAQ as the average duration. The workflow guide gives the applicant 60 days to provide corrections; that response deadline is not a 60-day review SLA.

Conditions
  • Object-specific published service duration, not a guaranteed complete product MA/transfer project duration.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Labels and identifiers
  • Existing stock and transition

Product information must match the approval

Fact-level verified

The internal and external label and printed or electronic leaflet must match the package information in the marketing-approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • The Article 38 prohibition on circulation/marketing unless labels/leaflet match the applicable approved particulars is a restriction. It gives no blanket old-stock sell-through period, relabelling authority or automatic disposal requirement after this change.
  • Labels and identifiers

Leaflet languages

Fact-level verified

The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.

Conditions
  • Applies to all medical products including devices

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Apply the Arabic/English leaflet rule and only a specifically authorized exception; the language rule does not itself approve the proposed identity change.
  • Labels and identifiers

Trade name, MAH, labels and GTIN are separate fields

Fact-level verified

The mixed device-applicable guide lists trade name, MAH/contact/address, manufacturer-related manufacturing-stage/site data, label/artwork attachments and a pack-size GTIN among fields that may be open for minor variation. Only fields actually open may be modified. The catalogue does not equate an internal orderable SMN/REF with model or GTIN/UDI, or establish that editing the MAH name field transfers the MA to a new legal person.

Conditions
  • Confirm the existing registered product/pack identifiers and proposed old-to-new mapping.
  • For an IVD, confirm its EDE device classification and the actual open fields before mapping an orderable REF to a registered product, model or pack identifier.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual open registered product/pack field and old-to-new identifier mapping. An orderable REF is not automatically GTIN/UDI/model, and editing a holder-name field is not an ownership-transfer decision.
  • Existing stock and transition

Expiry or lapse consequence

Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the ordinary-MA expiry/activity restriction; a pending renewal or accepted variation is not the specific EDE permission for continued activity. This does not establish an old-label or old-holder stock grace period.
  • Change-specific government fees

Conditions for this question

  • Only if the actual proposed product change qualifies for EDE’s minor-variation/product MA-data-amendment certificate; not a true legal-owner transfer price or a total covering company/site changes, new MA or a combined project.
  • Only a confirmed eligible product-MA amendment certificate under Annex item 28 (charged each time); this does not price a change of juridical MA owner or an entire combined project.
Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Map the actual change to an eligible Article 16 minor-change object. A true different-juridical MA owner also requires Article 17(2); this general minor-change rule does not establish that transfer’s detailed implementation or a fee.
  • Filing route and prior approval

Product amendment submission workflow

Fact-level verified

Search/select the registered product, modify the fields actually open for the product/pack, attach the applicable supporting documents, review/accept terms, proceed through checkout and submit for EDE processing. The resulting minor-variation certificate records approved change details; its multiple-section layout is not permission to group any proposed combination or a new juridical owner into one filing.

Conditions
  • Follow the current service sequence of completing the application, attaching the applicable documents and paying before submission. The guide illustrates product/pack selection, open fields, attachments, terms, checkout and the resulting certificate.
Certificate of amendment to registered medical-product marketing-authorization data — current Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Filing route and prior approval
  • Supporting documents

Expired MA: retain the active-renewal exception

Fact-level verified

The current amendment service rejects minor-variation requests after the MA expires unless a renewal application is active. Submit documents on the company’s official letterhead carrying its name/logo, and evidence of competent origin-country approval of the proposed changes where applicable. The current active-renewal exception qualifies the older guide’s unexpired-product rule; it does not independently authorize continued supply after MA expiry.

Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • The active-renewal acceptance exception concerns request eligibility, not continued supply or old-stock permission.
  • Filing route and prior approval

Manufacturer/site master data is a separate amendment object

Fact-level verified

If the registered manufacturer/company/site data changes, use the manufacturer-data amendment service for that object as applicable. Its site minor-variation guide requires an unexpired site and permits only certain open fields. Changing that record does not itself amend every product MA or transfer product MA ownership. A same-entity office/name change must first be located in the manufacturer master record and product approval particulars; do not assume a manufacturing-site move.

Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if the registered manufacturer/company/site master record actually changes. This is a separate service object and does not itself amend every product MA, transfer a product MA to a new legal person or prove that a pure office change is a factory relocation.
  • Supporting documents

Product-amendment materials and conditional device scope

Fact-level verified

The amendment service lists a company-signed/stamped minor-change application; the relevant change documents under the current applicable guide; the issued valid MA; a valid manufacturing-site registration; outer/inner packaging and leaflet; and, for certain changes, a sample and analysis certificate. Its medical-device branch is explicit. Select device-applicable materials and the actual change category; mixed pharmaceutical attachments such as active-substance or drug-PV materials are not a universal IVD/device checklist.

Conditions
  • The guide describes only two additional uploads in its minor-variation attachment screen; this screen limit does not remove otherwise applicable documentary requirements.
  • Read the current service requirement for a valid MA copy together with its exception accepting a minor-variation request while a renewal application is active; acceptance of the request does not itself authorize continued supply after expiry.
Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Select the medical-device change materials; mixed drug-specific attachments are not automatically a universal device/IVD checklist, and the list does not establish replacement CFS for every change.
  • Supporting documents

Materials for manufacturer/company-data amendment

Fact-level verified

The manufacturer-data service requires current origin-country authority approval of the requested changes and a signed/stamped letter comparing existing and proposed details. Its published list also includes certified company authorization, current GMP/manufacturing licence materials, product/site documentation and the current EDE registration certificate. Apply the actual device/site conditions; the mixed guide’s initial-registration attachment Y/N markers do not establish a blanket device exemption from this service list.

Conditions
  • This is a manufacturer/company-data service; do not present its documents as the complete true product MA-transfer dossier.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific government fees

Fee for the separate manufacturer/company-data certificate

Fact-level verified

The fee for a certificate modifying registration data of a medical company or factory holding a marketing right is AED 2,000 per certificate under Cabinet 40/2025 Annex item 27, consistent with the current manufacturer-data service. This is a separate object from the product MA amendment certificate in item 28.

Conditions
  • Only if that company/factory-data certificate is actually required; not the total for all proposed product changes or true-MA transfer.
Certificate of amendment of medical-products manufacturer/company registration data — Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific review time

Published duration for the applicable amendment service

Fact-level verified

The current EDE medical-product amendment service publishes 22 working days. Use this only once the proposed change qualifies for that service; it is not the duration of manufacturer-master-data amendment, a new MA, true juridical transfer or the whole preparation/foreign-approval/combined-change project.

Conditions
  • Published duration for the eligible product-MA amendment service only; preparation, foreign approvals, corrections and other service objects are separate.
  • No statutory stop-clock or guaranteed end-to-end completion promise is specified by this service page.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Change-specific review time

Published manufacturer-data amendment duration

Fact-level verified

EDE publishes 10 working days for the manufacturer/company-registration-data amendment service and describes this in its FAQ as the average duration. The workflow guide gives the applicant 60 days to provide corrections; that response deadline is not a 60-day review SLA.

Conditions
  • Object-specific published service duration, not a guaranteed complete product MA/transfer project duration.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Labels and identifiers
  • Existing stock and transition

Product information must match the approval

Fact-level verified

The internal and external label and printed or electronic leaflet must match the package information in the marketing-approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • The Article 38 prohibition on circulation/marketing unless labels/leaflet match the applicable approved particulars is a restriction. It gives no blanket old-stock sell-through period, relabelling authority or automatic disposal requirement after this change.
  • Labels and identifiers

Leaflet languages

Fact-level verified

The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.

Conditions
  • Applies to all medical products including devices

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Apply the Arabic/English leaflet rule and only a specifically authorized exception; the language rule does not itself approve the proposed identity change.
  • Labels and identifiers

Trade name, MAH, labels and GTIN are separate fields

Fact-level verified

The mixed device-applicable guide lists trade name, MAH/contact/address, manufacturer-related manufacturing-stage/site data, label/artwork attachments and a pack-size GTIN among fields that may be open for minor variation. Only fields actually open may be modified. The catalogue does not equate an internal orderable SMN/REF with model or GTIN/UDI, or establish that editing the MAH name field transfers the MA to a new legal person.

Conditions
  • Confirm the existing registered product/pack identifiers and proposed old-to-new mapping.
  • For an IVD, confirm its EDE device classification and the actual open fields before mapping an orderable REF to a registered product, model or pack identifier.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual open registered product/pack field and old-to-new identifier mapping. An orderable REF is not automatically GTIN/UDI/model, and editing a holder-name field is not an ownership-transfer decision.
  • Existing stock and transition

Expiry or lapse consequence

Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the ordinary-MA expiry/activity restriction; a pending renewal or accepted variation is not the specific EDE permission for continued activity. This does not establish an old-label or old-holder stock grace period.
  • Change-specific government fees

Conditions for this question

  • Only if the actual proposed product change qualifies for EDE’s minor-variation/product MA-data-amendment certificate; not a true legal-owner transfer price or a total covering company/site changes, new MA or a combined project.
  • Only a confirmed eligible product-MA amendment certificate under Annex item 28 (charged each time); this does not price a change of juridical MA owner or an entire combined project.
Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Map the actual change to an eligible Article 16 minor-change object. A true different-juridical MA owner also requires Article 17(2); this general minor-change rule does not establish that transfer’s detailed implementation or a fee.
  • Filing route and prior approval

Product amendment submission workflow

Fact-level verified

Search/select the registered product, modify the fields actually open for the product/pack, attach the applicable supporting documents, review/accept terms, proceed through checkout and submit for EDE processing. The resulting minor-variation certificate records approved change details; its multiple-section layout is not permission to group any proposed combination or a new juridical owner into one filing.

Conditions
  • Follow the current service sequence of completing the application, attaching the applicable documents and paying before submission. The guide illustrates product/pack selection, open fields, attachments, terms, checkout and the resulting certificate.
Certificate of amendment to registered medical-product marketing-authorization data — current Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Filing route and prior approval
  • Supporting documents

Expired MA: retain the active-renewal exception

Fact-level verified

The current amendment service rejects minor-variation requests after the MA expires unless a renewal application is active. Submit documents on the company’s official letterhead carrying its name/logo, and evidence of competent origin-country approval of the proposed changes where applicable. The current active-renewal exception qualifies the older guide’s unexpired-product rule; it does not independently authorize continued supply after MA expiry.

Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • The active-renewal acceptance exception concerns request eligibility, not continued supply or old-stock permission.
  • Supporting documents

Product-amendment materials and conditional device scope

Fact-level verified

The amendment service lists a company-signed/stamped minor-change application; the relevant change documents under the current applicable guide; the issued valid MA; a valid manufacturing-site registration; outer/inner packaging and leaflet; and, for certain changes, a sample and analysis certificate. Its medical-device branch is explicit. Select device-applicable materials and the actual change category; mixed pharmaceutical attachments such as active-substance or drug-PV materials are not a universal IVD/device checklist.

Conditions
  • The guide describes only two additional uploads in its minor-variation attachment screen; this screen limit does not remove otherwise applicable documentary requirements.
  • Read the current service requirement for a valid MA copy together with its exception accepting a minor-variation request while a renewal application is active; acceptance of the request does not itself authorize continued supply after expiry.
Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Select the medical-device change materials; mixed drug-specific attachments are not automatically a universal device/IVD checklist, and the list does not establish replacement CFS for every change.
  • Change-specific review time

Published duration for the applicable amendment service

Fact-level verified

The current EDE medical-product amendment service publishes 22 working days. Use this only once the proposed change qualifies for that service; it is not the duration of manufacturer-master-data amendment, a new MA, true juridical transfer or the whole preparation/foreign-approval/combined-change project.

Conditions
  • Published duration for the eligible product-MA amendment service only; preparation, foreign approvals, corrections and other service objects are separate.
  • No statutory stop-clock or guaranteed end-to-end completion promise is specified by this service page.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Labels and identifiers
  • Existing stock and transition

Product information must match the approval

Fact-level verified

The internal and external label and printed or electronic leaflet must match the package information in the marketing-approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • The Article 38 prohibition on circulation/marketing unless labels/leaflet match the applicable approved particulars is a restriction. It gives no blanket old-stock sell-through period, relabelling authority or automatic disposal requirement after this change.
  • Labels and identifiers

Leaflet languages

Fact-level verified

The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.

Conditions
  • Applies to all medical products including devices

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Apply the Arabic/English leaflet rule and only a specifically authorized exception; the language rule does not itself approve the proposed identity change.
  • Labels and identifiers

Trade name, MAH, labels and GTIN are separate fields

Fact-level verified

The mixed device-applicable guide lists trade name, MAH/contact/address, manufacturer-related manufacturing-stage/site data, label/artwork attachments and a pack-size GTIN among fields that may be open for minor variation. Only fields actually open may be modified. The catalogue does not equate an internal orderable SMN/REF with model or GTIN/UDI, or establish that editing the MAH name field transfers the MA to a new legal person.

Conditions
  • Confirm the existing registered product/pack identifiers and proposed old-to-new mapping.
  • For an IVD, confirm its EDE device classification and the actual open fields before mapping an orderable REF to a registered product, model or pack identifier.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual open registered product/pack field and old-to-new identifier mapping. An orderable REF is not automatically GTIN/UDI/model, and editing a holder-name field is not an ownership-transfer decision.
  • Existing stock and transition

Expiry or lapse consequence

Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the ordinary-MA expiry/activity restriction; a pending renewal or accepted variation is not the specific EDE permission for continued activity. This does not establish an old-label or old-holder stock grace period.
  • Change-specific government fees

Conditions for this question

  • Only if the actual proposed product change qualifies for EDE’s minor-variation/product MA-data-amendment certificate; not a true legal-owner transfer price or a total covering company/site changes, new MA or a combined project.
  • Only a confirmed eligible product-MA amendment certificate under Annex item 28 (charged each time); this does not price a change of juridical MA owner or an entire combined project.
Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Map the actual change to an eligible Article 16 minor-change object. A true different-juridical MA owner also requires Article 17(2); this general minor-change rule does not establish that transfer’s detailed implementation or a fee.
  • Filing route and prior approval

Product amendment submission workflow

Fact-level verified

Search/select the registered product, modify the fields actually open for the product/pack, attach the applicable supporting documents, review/accept terms, proceed through checkout and submit for EDE processing. The resulting minor-variation certificate records approved change details; its multiple-section layout is not permission to group any proposed combination or a new juridical owner into one filing.

Conditions
  • Follow the current service sequence of completing the application, attaching the applicable documents and paying before submission. The guide illustrates product/pack selection, open fields, attachments, terms, checkout and the resulting certificate.
Certificate of amendment to registered medical-product marketing-authorization data — current Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Filing route and prior approval
  • Supporting documents

Expired MA: retain the active-renewal exception

Fact-level verified

The current amendment service rejects minor-variation requests after the MA expires unless a renewal application is active. Submit documents on the company’s official letterhead carrying its name/logo, and evidence of competent origin-country approval of the proposed changes where applicable. The current active-renewal exception qualifies the older guide’s unexpired-product rule; it does not independently authorize continued supply after MA expiry.

Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • The active-renewal acceptance exception concerns request eligibility, not continued supply or old-stock permission.
  • Filing route and prior approval

Manufacturer/site master data is a separate amendment object

Fact-level verified

If the registered manufacturer/company/site data changes, use the manufacturer-data amendment service for that object as applicable. Its site minor-variation guide requires an unexpired site and permits only certain open fields. Changing that record does not itself amend every product MA or transfer product MA ownership. A same-entity office/name change must first be located in the manufacturer master record and product approval particulars; do not assume a manufacturing-site move.

Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if the registered manufacturer/company/site master record actually changes. This is a separate service object and does not itself amend every product MA, transfer a product MA to a new legal person or prove that a pure office change is a factory relocation.
  • Filing route and prior approval

Authorization ownership transfer

Fact-level verified

EDE may approve transfer of a medical-product marketing approval or conditional marketing approval to another party under the conditions and cases set by the Executive Regulation. Import, export and re-export permissions cannot be transferred; apply for a new permission when the marketing-right holder or the importing/exporting establishment changes.

Conditions
  • Actual transfer to a different legal person requires EDE approval and the applicable Executive Regulation conditions/cases. Article 17(2) does not expressly extend this permission to emergency-use approval.

Effective from 2025-01-02

Necessary Arabic original clauses independently rechecked on 21 October 2026 (Arts. 17(2), 33(2), physical 19/24); Arabic original prevails. This is a precise scope refinement over the existing verified English-expression row, not a fresh whole-law review.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only a transfer to a different legal person. EDE approval and the applicable Article 17(2) Executive Regulation conditions/cases are required; this clause does not provide the complete transfer dossier, fee, clock or permission to bundle changes. Import/export/re-export permissions require the separate Article 33(2) treatment.
  • Supporting documents

Product-amendment materials and conditional device scope

Fact-level verified

The amendment service lists a company-signed/stamped minor-change application; the relevant change documents under the current applicable guide; the issued valid MA; a valid manufacturing-site registration; outer/inner packaging and leaflet; and, for certain changes, a sample and analysis certificate. Its medical-device branch is explicit. Select device-applicable materials and the actual change category; mixed pharmaceutical attachments such as active-substance or drug-PV materials are not a universal IVD/device checklist.

Conditions
  • The guide describes only two additional uploads in its minor-variation attachment screen; this screen limit does not remove otherwise applicable documentary requirements.
  • Read the current service requirement for a valid MA copy together with its exception accepting a minor-variation request while a renewal application is active; acceptance of the request does not itself authorize continued supply after expiry.
Issuance of a Certificate of Amendment to Registered Marketing Authorization Data — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Select the medical-device change materials; mixed drug-specific attachments are not automatically a universal device/IVD checklist, and the list does not establish replacement CFS for every change.
  • Supporting documents

Materials for manufacturer/company-data amendment

Fact-level verified

The manufacturer-data service requires current origin-country authority approval of the requested changes and a signed/stamped letter comparing existing and proposed details. Its published list also includes certified company authorization, current GMP/manufacturing licence materials, product/site documentation and the current EDE registration certificate. Apply the actual device/site conditions; the mixed guide’s initial-registration attachment Y/N markers do not establish a blanket device exemption from this service list.

Conditions
  • This is a manufacturer/company-data service; do not present its documents as the complete true product MA-transfer dossier.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific government fees

Fee for the separate manufacturer/company-data certificate

Fact-level verified

The fee for a certificate modifying registration data of a medical company or factory holding a marketing right is AED 2,000 per certificate under Cabinet 40/2025 Annex item 27, consistent with the current manufacturer-data service. This is a separate object from the product MA amendment certificate in item 28.

Conditions
  • Only if that company/factory-data certificate is actually required; not the total for all proposed product changes or true-MA transfer.
Certificate of amendment of medical-products manufacturer/company registration data — Arabic service

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Change-specific review time

Published duration for the applicable amendment service

Fact-level verified

The current EDE medical-product amendment service publishes 22 working days. Use this only once the proposed change qualifies for that service; it is not the duration of manufacturer-master-data amendment, a new MA, true juridical transfer or the whole preparation/foreign-approval/combined-change project.

Conditions
  • Published duration for the eligible product-MA amendment service only; preparation, foreign approvals, corrections and other service objects are separate.
  • No statutory stop-clock or guaranteed end-to-end completion promise is specified by this service page.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual product/pack component confirmed eligible for this minor-variation service, with open fields and current service conditions. For combined changes this is a component rule, not a complete filing, transfer dossier, transfer clock or whole-project duration.
  • Change-specific review time

Published manufacturer-data amendment duration

Fact-level verified

EDE publishes 10 working days for the manufacturer/company-registration-data amendment service and describes this in its FAQ as the average duration. The workflow guide gives the applicant 60 days to provide corrections; that response deadline is not a 60-day review SLA.

Conditions
  • Object-specific published service duration, not a guaranteed complete product MA/transfer project duration.
Certificate of Amendment of Manufacturer Information — External User Guide

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only if this separate registered manufacturer/company/site-data object actually requires amendment. For a combination this component does not establish a product-MA transfer dossier, total fee, common effective date or whole-project clock.
  • Labels and identifiers
  • Existing stock and transition

Product information must match the approval

Fact-level verified

The internal and external label and printed or electronic leaflet must match the package information in the marketing-approval annex, or the details approved in the country of origin for a product exempt from marketing approval. EDE determines the required label and leaflet data.

Official English expression; Arabic original prevails. R217 independent review.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • The Article 38 prohibition on circulation/marketing unless labels/leaflet match the applicable approved particulars is a restriction. It gives no blanket old-stock sell-through period, relabelling authority or automatic disposal requirement after this change.
  • Labels and identifiers

Leaflet languages

Fact-level verified

The internal (package) leaflet, printed or electronic, must use at least Arabic and English, unless a decision is issued by the Chairman or his delegate.

Conditions
  • Applies to all medical products including devices

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Apply the Arabic/English leaflet rule and only a specifically authorized exception; the language rule does not itself approve the proposed identity change.
  • Labels and identifiers

Trade name, MAH, labels and GTIN are separate fields

Fact-level verified

The mixed device-applicable guide lists trade name, MAH/contact/address, manufacturer-related manufacturing-stage/site data, label/artwork attachments and a pack-size GTIN among fields that may be open for minor variation. Only fields actually open may be modified. The catalogue does not equate an internal orderable SMN/REF with model or GTIN/UDI, or establish that editing the MAH name field transfers the MA to a new legal person.

Conditions
  • Confirm the existing registered product/pack identifiers and proposed old-to-new mapping.
  • For an IVD, confirm its EDE device classification and the actual open fields before mapping an orderable REF to a registered product, model or pack identifier.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the actual open registered product/pack field and old-to-new identifier mapping. An orderable REF is not automatically GTIN/UDI/model, and editing a holder-name field is not an ownership-transfer decision.
  • Existing stock and transition

Expiry or lapse consequence

Fact-level verified

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Conditions
  • EDE may authorize continued activity for specific products if necessary

Effective from 2025-01-02

Official English expression independently compared in full with the UAE legislation portal; Arabic original prevails. R217 review, 18 September 2026.

Conditions for this question

  • Apply only where EDE classifies the product as a medical device/reagent covered by the cited device/medical-product rule.
  • Only the ordinary-MA expiry/activity restriction; a pending renewal or accepted variation is not the specific EDE permission for continued activity. This does not establish an old-label or old-holder stock grace period.
Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

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Tracked from official EDE publications · row IDs are stable — cite as regulations:uae:ae-classification