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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