United Arab Emirates Medical Device Regulations | EDE

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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

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.

Change-specific government fees

Minor-variation (amendment) certificate for registered MA data

Source-verified

AED 1,000

Per certificate

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

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.

Change-specific government fees

Minor-variation (amendment) certificate for registered MA data

Source-verified

AED 1,000

Per certificate

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

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.

Change-specific government fees

Minor-variation (amendment) certificate for registered MA data

Source-verified

AED 1,000

Per certificate

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

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.

Change-specific government fees

Minor-variation (amendment) certificate for registered MA data

Source-verified

AED 1,000

Per certificate

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →UDI, listing & traceability →Label, IFU & language →

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

Verified guidance on

Filing route and prior approval ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

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

An IVD product MA transfer needs EDE approval

Fact-level verified

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

Conditions

A transfer to a different legal person requires EDE approval under the applicable Executive Regulation conditions and cases; an editable holder-name or manufacturer/site record does not itself grant that transfer.
The Article 17(2) transfer permission covers an ordinary MA or conditional MA and does not expressly extend to emergency-use 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.
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.

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →Approval validity & renewal →

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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Use the minor-change route only for its applicable changes

Fact-level verified

Article 16 requires the marketing-right holder to apply to EDE for minor medical-product changes without resubmitting a new MA under Article 15. Listed cases include changes to product presentation/leaflet, manufacturing site or marketing-right holder, minor manufacturing-method changes and applicable product/use changes. A brand/artwork, same-entity name/address or REF proposal must be mapped to what actually changes; editable MAH fields alone do not establish the detailed legal-owner-transfer conditions.

Conditions

The true juridical MA/conditional-MA owner-transfer branch also requires Art 17(2) conditions and approval.
A pure office address update is not assumed to be an actual factory move.

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.
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

An IVD product MA transfer needs EDE approval

Fact-level verified

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

Conditions

A transfer to a different legal person requires EDE approval under the applicable Executive Regulation conditions and cases; an editable holder-name or manufacturer/site record does not itself grant that transfer.
The Article 17(2) transfer permission covers an ordinary MA or conditional MA and does not expressly extend to emergency-use 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.
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

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.

Labels and identifiers
Existing stock and transition

IVD labels must match approved product information

Fact-level verified

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

Conditions

Applies to IVDs/reagents within the medical-device/medical-product definition. Arabic original prevails.

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

IVD leaflet languages

Fact-level verified

Medical-product leaflets, printed or electronic, use at least Arabic and English unless the Chairperson or delegate issues an exception decision.

Conditions

Product-specific exceptions must be established; no blanket English-only IVD exception inferred.

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.

Existing stock and transition

An expired MA does not itself permit ongoing activity

Fact-level verified

The marketing-right holder cannot continue the activity authorized by an ordinary MA after expiry until renewal unless EDE permits continued activity for particular medical products where necessary. A pending variation or renewal application is not itself that permission.

Conditions

Ordinary MA clause; conditional approvals have separate Art 10 rules.

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 →

Changes after registration in United Arab Emirates

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

Use the minor-change route only for its applicable changes

Product amendment submission workflow

Expired MA: retain the active-renewal exception

Product-amendment materials and conditional device scope

Published duration for the applicable amendment service

Trade name, MAH, labels and GTIN are separate fields

Minor-variation (amendment) certificate for registered MA data

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

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

Use the minor-change route only for its applicable changes

Product amendment submission workflow

Expired MA: retain the active-renewal exception

Manufacturer/site master data is a separate amendment object

Product-amendment materials and conditional device scope

Materials for manufacturer/company-data amendment

Fee for the separate manufacturer/company-data certificate

Published duration for the applicable amendment service

Published manufacturer-data amendment duration

Trade name, MAH, labels and GTIN are separate fields

Minor-variation (amendment) certificate for registered MA data

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

What changes when the manufacturer's office address changes?

Use the minor-change route only for its applicable changes

Product amendment submission workflow

Expired MA: retain the active-renewal exception

Manufacturer/site master data is a separate amendment object

Product-amendment materials and conditional device scope

Materials for manufacturer/company-data amendment

Fee for the separate manufacturer/company-data certificate

Published duration for the applicable amendment service

Published manufacturer-data amendment duration

Trade name, MAH, labels and GTIN are separate fields

Minor-variation (amendment) certificate for registered MA data

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

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

Use the minor-change route only for its applicable changes

Product amendment submission workflow

Expired MA: retain the active-renewal exception

Product-amendment materials and conditional device scope

Published duration for the applicable amendment service

Trade name, MAH, labels and GTIN are separate fields

Minor-variation (amendment) certificate for registered MA data

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

Can a registration transfer to a different legal entity?

Use the minor-change route only for its applicable changes

Manufacturer/site master data is a separate amendment object

An IVD product MA transfer needs EDE approval

Trade name, MAH, labels and GTIN are separate fields

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

Can several changes be filed together?

Use the minor-change route only for its applicable changes

Product amendment submission workflow

Expired MA: retain the active-renewal exception

Manufacturer/site master data is a separate amendment object

An IVD product MA transfer needs EDE approval

Product-amendment materials and conditional device scope

Materials for manufacturer/company-data amendment

Fee for the separate manufacturer/company-data certificate

Published duration for the applicable amendment service

Published manufacturer-data amendment duration

Trade name, MAH, labels and GTIN are separate fields

IVD labels must match approved product information

IVD leaflet languages

An expired MA does not itself permit ongoing activity

What these codes are

Continue from regulations into practical research

Classify a device for United Arab Emirates

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