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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Egypt, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on March 22, 2019.

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