Egypt: Regulations for Medical Device and Reagents Registration and Importation for Great Britain

Based on the amendment made for the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023, Egyptian Drug Authority published a new procedure for registering and importing medical devices, laboratory supplies, and diagnostic reagents traded in the market of Great Britain.

Registration Processes

Manufacturers are required to provide a UKCA 13485: 2016 + ISO certificate in compliance with the Great Britain classification system. Manufacturers must also include all registration file requirements from the Regulatory Guide for the Registration of Medical Supplies in their submissions.

Import Approval Processes

In addition to the necessity of import approval files obtained from the Egyptian Medicines Authority, a UKCA 13485: 2016 + ISO certificate must be shown. The certificate must comply with the Great Britain classification system.

Apart from that, all concerned parties, manufacturers, or distributors are reminded of the transitional timeline for the CE-marked acceptance until 30 June 2025. It is necessary to obtain a UKCA mark starting from 1 July 2025.

For medical devices bearing CE marks in accordance with MDR/IVDR/IVDD, the transitional period of 5 years (up to 30 June 2030) or expiry certificates is applicable. While the MDD/AIMDD-compliant medical devices have certificates of expiration that are valid for 3 years (up to 30 June 2028). It is advisable for all manufacturers to keep an eye out for updates from the Medicines and Healthcare products Regulatory Agency (MHRA).

Source: Egyptian Drug Authority (EDA)