EG(EDA) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Egyptian medical device regulatory authority

The Egyptian Drug Authority (EDA, short for Egyptian Drug Authority) is a subordinate agency of the Ministry of Health. Its responsibility is to ensure public health by regulating the safety and quality of drugs (for humans and animals), biological products, medical devices, cosmetics, dietary supplements and pesticides.

Regulatory Authority's Official Website Link:https://edaegypt.gov.eg/en/

Administrative Regulation

Law No. (151) of 2019.

Egyptian Medical Device Law Law No. 10 of 2003.

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:

Entry requirements

① ISO 13485 Quality Management System

② If there is no local entity in Egypt, an Egyptian registered holder (referred to as ERH) must be designated.

③ All medical devices must be registered with the Egyptian Medicines Authority (EMA). To apply for registration permission, complete technical documents must be provided.

④ Certification Statement

⑤ ISO Certificate

⑥FSC

⑦ Authorization Letter

Reference countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden. Switzerland, United Kingdom and the United States of America.

Registration Language

The labels for household instruments must be provided in Arabic, while the labels for professional instruments must be provided in either Arabic or English.

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.

Registration Flow、Cycle & Official Fee

1. Registration Flow

2. Registration Period and Official Fees

Registration Cycle:

Based on the experience of the Wiselink project and the relevant regulations, reviewing the technical documents may take up to 30 working days. The manufacturer has 60 working days to respond to the comments made by EDA/DPPC. After the DPPC completes the verification, it will issue the import approval, while EDA will issue the marketing authorization. The verification activities may take up to 18 months.

Official Fees:

Product Registration & Renewal (EGP) New Registration Normal: 10000 New Registration Fast: 20000 Re‑registration Normal: 10000 Re‑registration Fast: 20000

IVD Bulk Bundle (EGP, IVD‑only) Bundle 2‑25 files: 25005 Bundle 2‑100 files: 55000

Registration Variation (EGP) Major Variation Normal: 6000 Major Variation Fast: 12000 Minor Variation Normal: 2000 Minor Variation Fast: 4000

Manufacturer Filing Fees Add manufacturer (product registration temporary): 10005 EGP Add legal manufacturer to Scientific office: 13000 EGP Ministry of Trade S14 document: 1000 USD Add manufacturer to EDA ERH import record: 1000 USD

EDA Issuance of Medical Device Import Permit EDA Issuing Import Permit: 500 USD

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.

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