Medical Device Registration and Approval in Egypt
General country-specific regulatory information is provided on this page for medical device registration and approval in Egypt.
Last updated on November 22nd, 2021.
Medical Device Regulations and Classification in Egypt
REGULATORY AUTHORITY: Medical devices are regulated by the Central Administration for Pharmaceutical Affairs (CAPA), part of the Egyptian Drug Authority (EDA).
CLASSIFICATION SYSTEM: Egypt has adopted the European Risk-based Classification System for medical devices.
Medical Devices: Class I, IIa, IIb, III
IVD Devices: Devices for self-testing, Annex II List A or List B
TIMEFRAME: The timeframe for the registration process is eight months.
Class I: The registration process takes about eight months.
Class II: The registration process takes about eight months.
Class III: The registration process takes about eight months.
IVD Devices: The registration process takes about eight months.
SPECIAL REQUIREMENTS:
Audits: There are no related special requirements.
Technical Local Tests: There are no related special requirements.
Clinical Evaluation/studies: There are no related special requirements.
LOCAL FEES:
Application review fees: $175 US
Manufacturer registration: None
LICENSE VALIDITY: Licenses issued in Egypt are valid for ten years.
LICENSE TRANSFER: Licenses can be transferred in Egypt.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required and must be an importer.
For detailed device-specific compliance information for each market, including Egypt, to expedite the preparation of your medical device or IVD registration application.
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