Medical Device Regulatory Requirements in Egypt
| Regulatory Authority |
Egyptian Drug Authority (EDA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,II,III,IV |
| Medical Device Regulations |
Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
Regulatory Rules of Registration and Market authorization of In Vitro Diagnostic Medical Devices |
| Registration Process |
Refer to Heading 4 for the registration process of medical device
| Click Here
|
| Registration Timeline |
approximately 7 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Arabic (for home-use products) and English Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
Re-registration of medical devices shall be every 10 years based on a request submitted to the Central Administration for Medical Devices. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025