Snapshot

The Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates pathway has been developed by the of Egypt.

This pathway can be used where Sterile and non-sterile medical devices (including in-vitro diagnostics).

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is REGISTRATION OF STERILE IMPORTED AND LOCAL MEDICAL DEVICES THAT HAVE INTERNATIONAL QUALITY CERTIFICATES: 1. The company should apply on the electronic platform at the following link: medevice.edaegypt.gov.eg 2. The company will receive a response through the platform within 5 working days from the date of submitting a normal track request and 3 working days for the fast-track request with acceptance/rejection/or suspending the request until meeting the requirements. If the file is accepted: the request is directed to the reviewer pharmacist and the unit head for studying, reporting and sending the requirements for the company for completion. When the company meets the necessary requirements, the request will be completed on the platform with the same request number previously acquired. 3. The file is reviewed and requirements are sent on the platform within 20 working days from the date of accepting a normal track file and 7 working days for fast-track files. REGISTRATION OF NON-STERILE IMPORTED AND LOCAL MEDICAL DEVICES THAT HAVE INTERNATIONAL QUALITY CERTIFICATES: 6 months, and then as workflow stated above. .