Egypt medical device regulations

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.

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.

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.

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.

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.

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.

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.