Regulatory Services in Egypt
Medical device and in-vitro
diagnostic Registration services
Complete registration management with the Egyptian Drug Authority. We handle the entire submission process, from preparation documents to final approval.
Process Steps
for Medical device and in-vitro diagnostic Registration services
Technical Documentation Preparation
Provide Technical file Templates to facilitate the process according to EDA requirements (COA, Storage Conditions, intended use, shelf life, tabilty study, Doc… etc.)
MeDevice Platform Registration & Submission
Receiving initial acceptance number in 2 weeks – 1 month
EDA Review Process
1-Scientific Committee review (if non-reference country)
2- Medical device vigilance review (for Class IIb & III devices)
3- Standard EDA review for other cases
Registration Approval & License Issuance
Registration license issuance (valid for 10 years)
FAQs About Medical device and in-vitro diagnostic Registration services
What is the Egyptian Drug Authority (EDA)?
The EDA is Egypt’s primary regulatory body responsible for ensuring the safety, quality, and efficacy of medical devices, pharmaceuticals, and other health products.
How long does the registration process take?
Registration timelines vary by device classification it usually takes round 6-12 months
What reference markets does Egypt recognize?
Egypt recognizes prior authorizations from:
Belgium 🇧🇪
France 🇫🇷
Germany 🇩🇪
Italy 🇮🇹
Luxembourg 🇱🇺
Netherlands 🇳🇱
Austria 🇦🇹
Finland 🇫🇮
Sweden 🇸🇪
Norway 🇳🇴
Denmark 🇩🇰
Ireland 🇮🇪
United Kingdom 🇬🇧
Greece 🇬🇷
Portugal 🇵🇹
Spain 🇪🇸
Bulgaria 🇧🇬
Romania 🇷🇴
Cyprus 🇨🇾
Czech Republic 🇨🇿
Estonia 🇪🇪
Hungary 🇭🇺
Latvia 🇱🇻
Lithuania 🇱🇹
Malta 🇲🇹
Poland 🇵🇱
Slovakia 🇸🇰
Slovenia 🇸🇮
Australia 🇦🇺
New Zealand 🇳🇿
United States 🇺🇸
Canada 🇨🇦
Japan 🇯🇵
Switzerland 🇨🇭
Liechtenstein 🇱🇮
Croatia 🇭🇷
How long is the registration valid?
Medical device registrations are valid for 10 years. Renewal applications must be submitted during the first 3 months of the final year of validity. Trading is permitted for up to one year after expiry while renewal is pending.
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