Chapter 1 Egyptian EDA administration information abstract

1. Administration and Abstract

The Egyptian Drug Authority (EDA), a subsidiary organization of the Ministry of Health, is responsible for guarding the health of the population by regulating the safety and quality of medicines (human and veterinary), biological agents, medical devices, cosmetics, dietary supplements, and pesticides.

2. Administrative Regulation

[ Law No. (151) of 2019.]    

[Egyptian Medical Device Law Law No. 10 of 2003]

3. Risk Level Classification of Medical Device and IVD Products

Medical device classification: Egypt divides medical devices into four categories, from low risk to high risk: Class I, Class II a, Class II b and Class III.

IVD product classification: 

4. Entry requirements

①ISO 13485 quality management system

②If there is no local company in Egypt, an Egyptian Registration Holder (ERH) must be appointed.

③All medical devices must be registered with the Egyptian Medicines Agency (EMA). Complete technical documentation is required to apply for registration license

④ Declaration of conformity

⑤ISO Certificate

⑥FSC

⑦ Letter of Attorney

5. Registration Language

Labels must be provided in Arabic for household instruments and in Arabic or English for professional use instruments.

6. Egyptian ERH

In the Egyptian medical device registration process, ERH (Egyptian Registration Holder) refers to the designated local representative of manufacturer in Egypt to help the manufacturer import the device to Egypt and to be responsible for post-marketing surveillance activities in the region. ERH's responsibilities include importing equipment to Egypt, handling communications with the Egyptian Drug Authority (EDA), and handling post-marketing surveillance.

Role and importance of ERH:

Communication Bridge: ERH acts as a bridge between manufacturers and local Egyptian regulation agency, handling communication and coordination with the EDA.

Post-marketing surveillance: ERH is responsible for post-marketing surveillance activities in Egypt to ensure compliance and safety of medical devices on the market.

Chapter 2 Registration Flow、Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Registration Cycle:

Based on the experience with the Wiselink project and an overview of relevant regulations, it can take up to 30 working days to audit technical documents and manufacturers have 60 working days to respond to comments made by the EDA/DPPC. The DPPC issues import approvals upon completion of validation, while the EDA issues marketing authorizations, whose validation activities can take up to 18 months.

Official Fees:

Evaluation/Review of Imported Medical Device Registration Documents: Common Channel: $98, Fast Track Registration: $421

Chapter 3 FAQ

Q: How long is the validity period of certificate of the medical device registration in Egypt?

A: It is valid for 5 years.

Q: How to renew the certificate of medical device registration in Egypt after expiration?

A: Renewal application should be submitted to the Medical Device EDA within the last 6 months of the expiration date. In case of no change, it is submitted to the Medical Device Registration Committee for approval; in case of change, it is first evaluated by the Central Authority and then submitted to the Committee for approval.