Regulatory Services in Egypt
EDA Medical Device Variation Services
We provide streamlined solutions to manage and update your registered medical devices. Our goal is to ensure your licenses remain compliant with regulatory changes without disrupting your operations.
Our Scope:
Add Distributor
Add new distributor to existing registration
License Transfer
Change ownership
Major Variations
Changes to product, labeling, IFU, or manufacturing
Minor Artwork Update
Minor labeling updates
FAQs About EDA Medical Device Variation Services
What types of changes can be submitted for a registered medical device?
You can submit different types of changes such as adding a distributor, transferring ownership or authorized representative, or updating product details, labeling, or manufacturing information.
What happens after a variation is approved?
Once the variation is approved, the product registration is updated, and an updated license or official record reflecting the change is issued.
How long does a variation request take?
The timeline depends on the type of change. Minor updates are usually processed faster, while major variations may take longer due to detailed review by the authority.
Can multiple changes be submitted in one request?
multiple related changes can be submitted together.
Is it mandatory to submit a variation before implementing changes?
It depends on the type of change.
Some changes must be approved by the authority before implementation, especially major variations that may affect the safety or performance of the device.
However, certain minor changes can be implemented first and then notified to the authority
Why to Choose FDRAC
Experienced team
End-to-End solution
Faster market access
Business-focused approach
Transparent pricing
Proven Experience
Our Experts here for your Company
Ensuring your project’s success
Delivering the highest quality and compliance
Working as an extension of your business
This Service is Right for You
If You Are:
International Manufacturers
Looking to register and access the Egyptian market
Local Agents & Distributors
Managing product registration and compliance with EDA
Healthcare & Medical Businesses
Seeking market entry or expansion in Egypt