How to register a medical device in Egypt?

To register a medical device in Egypt, you must appoint a local authorized representative, determine the device classification, prepare the technical file with quality certifications (ISO 13485/CE/FDA), and submit it to the Egyptian Drug Authority (EDA) for approval before entering the market.

Why is EDA registration important for manufacturers?

Without EDA approval, medical devices cannot be imported, marketed, or sold in Egypt. It ensures products meet safety, quality, and performance standards.

Can foreign medical device manufacturers register directly with the EDA?

No, foreign manufacturers must appoint a local authorized representative in Egypt to complete the registration and act as the point of contact with the EDA.

Does EDA registration cover both medical devices and IVDs?

Yes, the Egyptian Drug Authority regulates both medical devices and in-vitro diagnostic (IVD) products, and both require separate registrations.

Welcome to Operon Strategist

Medical Device Consulting for Egypt

Navigating Egypt’s medical device regulations under the Egyptian Drug Authority (EDA) can be challenging. Operon Strategist simplifies the process by helping manufacturers and distributors register, certify, and launch medical devices in Egypt with complete regulatory support. We deliver tailored solutions aligned with local and international standards to ensure compliance, faster approvals, and smooth market entry — from plant setup and documentation to certification and post-approval assistance.

LET'S GET STARTED

Turnkey Project Consultants

Regulatory Approvals

Leading Medical Device Consultant For Egypt

Operon Strategist is a premier medical device consulting firm dedicated to empowering manufacturers in navigating the complex regulatory landscape in Egypt. Our expert regulatory guidance is tailored to support the strategic development of healthcare manufacturers, with a particular focus on EDA registration.

Our Comprehensive Services Include:

Turnkey Services: We offer customized solutions designed to help manufacturers establish world-class production facilities that meet all regulatory standards.
System Implementation: Our team provides seamless integration of regulatory systems, ensuring your operations comply with local and international regulations.
Training & Licensing: We deliver tailored training programs and licensing assistance to equip your team with the knowledge and skills necessary to tackle regulatory challenges confidently.
Regulatory Approvals & Certifications: Benefit from our expert support in obtaining essential approvals and certifications, streamlining your path to market entry.

Get in Touch for your medical device consulting enquiries

FDA, CDSCO and CE.

MEDICAL DEVICE REGULATORY CONSULTING SERVICES FOR EGYPT

Why Choose Operon Strategist?

With a global footprint, we serve a diverse clientele that includes startups and well-established medical device manufacturers from countries such as India, South Africa, the USA, the UK, Costa Rica, Oman, and Iran. Our team of experienced consultants possesses the knowledge and expertise to help businesses of all sizes navigate the intricate world of medical device regulations.

Ready to ensure compliance and success in the Egyptian market? Contact us today for a free consultation and take the first step towards meeting your regulatory goals.

TESTIMONIALS

 5/5

“We have had good experience working with OperonStrategist the Medical Device Consultant, The team is experienced, Knowledgeable, result oriented, committed and professional in training and execution of the project, We strongly recommend Operon Strategist for all the services”

Arun Kumar - Director

MP Qatar Trading, Qatar

 5/5

“Operon Strategist is an outstanding medical device consulting firms with whom I will do business again and these are my reasons. A true problem solver Very Reliable”

Zak Kouloughi - President

Tradeline Medical Lab, USA

 5/5

The Team at Operon Strategist is reliable to work with & they provide excellent regulatory consultancy. They provide round the clock support & all their efforts are much appreciated.

Dr Apurv Patwardhan - Director

Australian Orthopedic Pvt. Ltd, India