Egypt medical device regulations

Changing the registered trade name of a medical device requires cancellation of the existing registration licence and a new registration application. A change confined to logo, layout, colour or similar non-significant label presentation can use notification only when it does not change registration-licence data or the device’s safety and performance.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

EGP 5,000

Per application

EGP 7,000

Per application

Changing the registered trade name of a medical device requires cancellation of the existing registration licence and a new registration application. A change confined to logo, layout, colour or similar non-significant label presentation can use notification only when it does not change registration-licence data or the device’s safety and performance.

The MD variation table places a manufacturer-name change at the same address, a legal-manufacturer address change, and changing or adding a legal manufacturer while the actual manufacturer is unchanged in the Tell and Do category. Obtain an initial acceptance number before marketing changed consignments. The corresponding identity-change dossier rows require the trade name and other declared device characteristics to remain unchanged. Changing both the legal manufacturer and actual manufacturer requires new registration.

The MD guideline prohibits concurrent applications to the Variation Administration and Registration Administration for the same registration licence; the variation request is cancelled in that situation. An actual trade-name change requires a new registration, and changing both legal manufacturer and actual manufacturer also requires new registration. These rules take precedence over treating each identity or code edit as a separate ordinary variation.

For an eligible manufacturer-name, legal-manufacturer address or legal-manufacturer change under rows9–11, submit the specified payment evidence, attested representative delegation, vigilance commitment, original valid registration licence, updated quality/free-sale or CFG evidence and DoC, no-change letter and manufacturer-signed/stamped updated labels. The name-change row identifies old and new manufacturer names and addresses and updates the importer record. The legal-address row expressly identifies old/new legal addresses and the actual manufacturer and its address. The legal-manufacturer-change row additionally requires the new legal manufacturer in the importer record and the Chamber-of-Commerce-authenticated relationship letter between manufacturer affiliates. Apply the exact row; these are not one universal checklist.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

For an eligible MD variation file, the first receiving response is published as eight working days for the ordinary track or five for the fast track from request submission. File review and issue of requirements are published as twenty-five working days for the ordinary track or ten for the fast track from file receipt. Missing documents may suspend the file for a maximum of ninety working days before cancellation. Separately, sixty working days without applicant follow-up leads to archiving/cancellation and suspension of the placing period; resubmission follows the stated steps again. Final licence issuance follows fulfilment and required approvals. These are separate stages, not a guaranteed end-to-end approval period.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

EGP 5,000

Per application

EGP 7,000

Per application

The MD variation table places a manufacturer-name change at the same address, a legal-manufacturer address change, and changing or adding a legal manufacturer while the actual manufacturer is unchanged in the Tell and Do category. Obtain an initial acceptance number before marketing changed consignments. The corresponding identity-change dossier rows require the trade name and other declared device characteristics to remain unchanged. Changing both the legal manufacturer and actual manufacturer requires new registration.

The MD guideline prohibits concurrent applications to the Variation Administration and Registration Administration for the same registration licence; the variation request is cancelled in that situation. An actual trade-name change requires a new registration, and changing both legal manufacturer and actual manufacturer also requires new registration. These rules take precedence over treating each identity or code edit as a separate ordinary variation.

For an eligible manufacturer-name, legal-manufacturer address or legal-manufacturer change under rows9–11, submit the specified payment evidence, attested representative delegation, vigilance commitment, original valid registration licence, updated quality/free-sale or CFG evidence and DoC, no-change letter and manufacturer-signed/stamped updated labels. The name-change row identifies old and new manufacturer names and addresses and updates the importer record. The legal-address row expressly identifies old/new legal addresses and the actual manufacturer and its address. The legal-manufacturer-change row additionally requires the new legal manufacturer in the importer record and the Chamber-of-Commerce-authenticated relationship letter between manufacturer affiliates. Apply the exact row; these are not one universal checklist.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

For an eligible MD variation file, the first receiving response is published as eight working days for the ordinary track or five for the fast track from request submission. File review and issue of requirements are published as twenty-five working days for the ordinary track or ten for the fast track from file receipt. Missing documents may suspend the file for a maximum of ninety working days before cancellation. Separately, sixty working days without applicant follow-up leads to archiving/cancellation and suspension of the placing period; resubmission follows the stated steps again. Final licence issuance follows fulfilment and required approvals. These are separate stages, not a guaranteed end-to-end approval period.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

EGP 5,000

Per application

EGP 7,000

Per application

Changing the registered trade name of a medical device requires cancellation of the existing registration licence and a new registration application. A change confined to logo, layout, colour or similar non-significant label presentation can use notification only when it does not change registration-licence data or the device’s safety and performance.

The MD variation table places a manufacturer-name change at the same address, a legal-manufacturer address change, and changing or adding a legal manufacturer while the actual manufacturer is unchanged in the Tell and Do category. Obtain an initial acceptance number before marketing changed consignments. The corresponding identity-change dossier rows require the trade name and other declared device characteristics to remain unchanged. Changing both the legal manufacturer and actual manufacturer requires new registration.

The MD guideline prohibits concurrent applications to the Variation Administration and Registration Administration for the same registration licence; the variation request is cancelled in that situation. An actual trade-name change requires a new registration, and changing both legal manufacturer and actual manufacturer also requires new registration. These rules take precedence over treating each identity or code edit as a separate ordinary variation.

The MD registration guideline generally requires the same trade name, GMDN/UMDN code, classification, intended use, manufacturer, raw materials and age group for one registration number, with the stated size exception. It expressly says sutures are not separated merely because raw materials differ and are granted one registration licence. Outside the applicable exceptions, differences in the listed elements require separate registrations; devices sharing those elements but differing otherwise are referred to the specialised scientific committee to decide separate registration. Several REF rows or a common portfolio owner alone do not establish one registration.

Minimum label data: trade name, product name, product code/model/Ref, batch or serial number, special handling and storage precautions, single-use indication where applicable, expiry date (month/year at least), UDI on label or packaging when applied, factory name/address and country of origin, sterilization word/symbol plus method, and the Egyptian importing company's full name and address as recorded in the importers registry.

For an eligible manufacturer-name, legal-manufacturer address or legal-manufacturer change under rows9–11, submit the specified payment evidence, attested representative delegation, vigilance commitment, original valid registration licence, updated quality/free-sale or CFG evidence and DoC, no-change letter and manufacturer-signed/stamped updated labels. The name-change row identifies old and new manufacturer names and addresses and updates the importer record. The legal-address row expressly identifies old/new legal addresses and the actual manufacturer and its address. The legal-manufacturer-change row additionally requires the new legal manufacturer in the importer record and the Chamber-of-Commerce-authenticated relationship letter between manufacturer affiliates. Apply the exact row; these are not one universal checklist.

For an eligible addition, change or cancellation of MD codes, the variation dossier includes the original licence, authorisation and vigilance documents, quality/free-sale or CFG evidence showing the relevant device identity and codes, a manufacturer declaration, a justified no-change letter, a signed comparison of the old and proposed codes and their technical characteristics, and updated signed label/IFU artwork. Code additions are restricted for certain named device types; other differences can require scientific-committee review. A commercial order code is not automatically a UDI or a new model.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

For an eligible MD variation file, the first receiving response is published as eight working days for the ordinary track or five for the fast track from request submission. File review and issue of requirements are published as twenty-five working days for the ordinary track or ten for the fast track from file receipt. Missing documents may suspend the file for a maximum of ninety working days before cancellation. Separately, sixty working days without applicant follow-up leads to archiving/cancellation and suspension of the placing period; resubmission follows the stated steps again. Final licence issuance follows fulfilment and required approvals. These are separate stages, not a guaranteed end-to-end approval period.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

EGP 5,000

Per application

EGP 7,000

Per application

The MD variation table places a manufacturer-name change at the same address, a legal-manufacturer address change, and changing or adding a legal manufacturer while the actual manufacturer is unchanged in the Tell and Do category. Obtain an initial acceptance number before marketing changed consignments. The corresponding identity-change dossier rows require the trade name and other declared device characteristics to remain unchanged. Changing both the legal manufacturer and actual manufacturer requires new registration.

The MD guideline prohibits concurrent applications to the Variation Administration and Registration Administration for the same registration licence; the variation request is cancelled in that situation. An actual trade-name change requires a new registration, and changing both legal manufacturer and actual manufacturer also requires new registration. These rules take precedence over treating each identity or code edit as a separate ordinary variation.

A transfer of the MD registration between Egyptian applicant companies has its own dossier: the original valid licence, the old applicant’s duly attested waiver, new importer/company or authorised-office documents, the legal manufacturer’s authorisation and termination evidence, and the applicable payment, authorisation and vigilance documents. Scientific-office and affiliated-office cases have additional conditions. These local-applicant documents do not by themselves establish transfer to a different foreign legal manufacturer.

The MD registration guideline generally requires the same trade name, GMDN/UMDN code, classification, intended use, manufacturer, raw materials and age group for one registration number, with the stated size exception. It expressly says sutures are not separated merely because raw materials differ and are granted one registration licence. Outside the applicable exceptions, differences in the listed elements require separate registrations; devices sharing those elements but differing otherwise are referred to the specialised scientific committee to decide separate registration. Several REF rows or a common portfolio owner alone do not establish one registration.

For an eligible manufacturer-name, legal-manufacturer address or legal-manufacturer change under rows9–11, submit the specified payment evidence, attested representative delegation, vigilance commitment, original valid registration licence, updated quality/free-sale or CFG evidence and DoC, no-change letter and manufacturer-signed/stamped updated labels. The name-change row identifies old and new manufacturer names and addresses and updates the importer record. The legal-address row expressly identifies old/new legal addresses and the actual manufacturer and its address. The legal-manufacturer-change row additionally requires the new legal manufacturer in the importer record and the Chamber-of-Commerce-authenticated relationship letter between manufacturer affiliates. Apply the exact row; these are not one universal checklist.

For an eligible addition, change or cancellation of MD codes, the variation dossier includes the original licence, authorisation and vigilance documents, quality/free-sale or CFG evidence showing the relevant device identity and codes, a manufacturer declaration, a justified no-change letter, a signed comparison of the old and proposed codes and their technical characteristics, and updated signed label/IFU artwork. Code additions are restricted for certain named device types; other differences can require scientific-committee review. A commercial order code is not automatically a UDI or a new model.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

For an eligible MD variation file, the first receiving response is published as eight working days for the ordinary track or five for the fast track from request submission. File review and issue of requirements are published as twenty-five working days for the ordinary track or ten for the fast track from file receipt. Missing documents may suspend the file for a maximum of ninety working days before cancellation. Separately, sixty working days without applicant follow-up leads to archiving/cancellation and suspension of the placing period; resubmission follows the stated steps again. Final licence issuance follows fulfilment and required approvals. These are separate stages, not a guaranteed end-to-end approval period.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

EGP 5,000

Per application

EGP 7,000

Per application

The MD variation table places a manufacturer-name change at the same address, a legal-manufacturer address change, and changing or adding a legal manufacturer while the actual manufacturer is unchanged in the Tell and Do category. Obtain an initial acceptance number before marketing changed consignments. The corresponding identity-change dossier rows require the trade name and other declared device characteristics to remain unchanged. Changing both the legal manufacturer and actual manufacturer requires new registration.

The MD guideline prohibits concurrent applications to the Variation Administration and Registration Administration for the same registration licence; the variation request is cancelled in that situation. An actual trade-name change requires a new registration, and changing both legal manufacturer and actual manufacturer also requires new registration. These rules take precedence over treating each identity or code edit as a separate ordinary variation.

A transfer of the MD registration between Egyptian applicant companies has its own dossier: the original valid licence, the old applicant’s duly attested waiver, new importer/company or authorised-office documents, the legal manufacturer’s authorisation and termination evidence, and the applicable payment, authorisation and vigilance documents. Scientific-office and affiliated-office cases have additional conditions. These local-applicant documents do not by themselves establish transfer to a different foreign legal manufacturer.

The MD registration guideline generally requires the same trade name, GMDN/UMDN code, classification, intended use, manufacturer, raw materials and age group for one registration number, with the stated size exception. It expressly says sutures are not separated merely because raw materials differ and are granted one registration licence. Outside the applicable exceptions, differences in the listed elements require separate registrations; devices sharing those elements but differing otherwise are referred to the specialised scientific committee to decide separate registration. Several REF rows or a common portfolio owner alone do not establish one registration.

For an eligible manufacturer-name, legal-manufacturer address or legal-manufacturer change under rows9–11, submit the specified payment evidence, attested representative delegation, vigilance commitment, original valid registration licence, updated quality/free-sale or CFG evidence and DoC, no-change letter and manufacturer-signed/stamped updated labels. The name-change row identifies old and new manufacturer names and addresses and updates the importer record. The legal-address row expressly identifies old/new legal addresses and the actual manufacturer and its address. The legal-manufacturer-change row additionally requires the new legal manufacturer in the importer record and the Chamber-of-Commerce-authenticated relationship letter between manufacturer affiliates. Apply the exact row; these are not one universal checklist.

For an eligible addition, change or cancellation of MD codes, the variation dossier includes the original licence, authorisation and vigilance documents, quality/free-sale or CFG evidence showing the relevant device identity and codes, a manufacturer declaration, a justified no-change letter, a signed comparison of the old and proposed codes and their technical characteristics, and updated signed label/IFU artwork. Code additions are restricted for certain named device types; other differences can require scientific-committee review. A commercial order code is not automatically a UDI or a new model.

When a trade-name change or another applicable trigger requires fresh registration, the imported-device dossier includes manufacturer/parent authorisation, current importer/company and agency documents, reference-country free-sale or permitted FDA CFG evidence, applicable conformity and quality certificates, the legal manufacturer’s signed declaration identifying trade name, codes/sizes and actual factory, and the technical file, artwork and instructions required for the device. The reference-country, risk-class and certificate-authenticity alternatives remain applicable.

For an eligible MD variation file, the first receiving response is published as eight working days for the ordinary track or five for the fast track from request submission. File review and issue of requirements are published as twenty-five working days for the ordinary track or ten for the fast track from file receipt. Missing documents may suspend the file for a maximum of ninety working days before cancellation. Separately, sixty working days without applicant follow-up leads to archiving/cancellation and suspension of the placing period; resubmission follows the stated steps again. Final licence issuance follows fulfilment and required approvals. These are separate stages, not a guaranteed end-to-end approval period.

The device/IVD labelling table identifies trade or product name, code/model/REF, applicable batch or serial and date information, UDI when applied, factory identity and origin, and the Egyptian importer’s registered name and address. Imported products must carry the mandatory information. Covering different information with an overlabel or applying incompatible double labels is prohibited until the required legal and technical steps are completed; a record update is not a general relabelling or old-stock permission.

The UDI guideline distinguishes internal reference codes from the UDI. Changes such as brand/trade name or device version/model require assessment under the new-UDI-DI rules; non-DI record changes have a ten-working-day update requirement. The May 2026 expression says the enforcement timetable for label UDI carriers and direct marking will be announced after market setup. Confirm the applicable announced implementation stage rather than assuming every label-carrier deadline has already begun.

Label data for devices traded in Egypt must be written in Arabic or English at least, so it can be read and understood by medical professionals and ordinary citizens; the labelling guideline itself is issued in Arabic with an English translation, and the Arabic text prevails in case of inconsistency.

EGP 5,000

Per application

EGP 7,000

Per application