Within the framework of the state's plan to localize the medical devices industry and streamline registration procedures for national factories holding international quality certificates, "The Egyptian Drug Authority (EDA), represented by the the Central Administration of Medical Devices,  announces the facilitation of technical file requirements for locally manufactured medical devices, according to the following regulations:
Local factories holding a CE Certificate are permitted to submit registration (or re-registration) files without the need to provide the following documents:
- Free Sale Certificate (FSC) from reference countries.
- Stability Studies.
- Biocompatibility Test Reports.
General Provisions:
The Egyptian Drug Authority (EDA) reserves the right to request Stability Studies and Biocompatibility Test Reports when necessary or as technically required.
Commitment to submitting all other documents specified in the Regulatory Guideline is mandatory to ensure the safety and efficacy of Egyptian medical devices.