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MIDDLE EAST
EGYPT

EGYPT

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Market Information

Egypt’s healthcare expenditure per capita is expected to be US$16.64bn by 2024.

Market Trend: The healthcare insurance market in Egypt is anticipated to expand, progressing from $5.67 billion in 2022 to $11.39 billion by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 9.1% between 2022 and 2030. In 2019, Egypt's healthcare spending constituted 4.74% of the GDP, equating to $150 per individual.

 

Egypt’s medical equipment market amounts to $3.0 billion in 2022, with an anticipated growth rate exceeding 7% over the period from 2022 to 2027.

 

The Egyptian Drug Authority (EDA), established under Law No. 151 of 2019, is the national regulatory body reporting to the Prime Minister. It oversees the registration, licensing, and regulation of pharmaceuticals, medical devices, biologicals, cosmetics, and related raw materials. The EDA ensures product safety, quality, and effectiveness

through inspections, laboratory analysis, and evaluation of clinical research in line with international standards. It also manages the release of imported medical products and regulatory data exchange.

Market Info

Medical Device Regulation

Central Administration for Pharmaceutical Affairs (CAPA), under the MOH.

https://edaegypt.gov.eg/ar/edaspire/edaspire-2/biographies/

Regulation
Classification, Fees, Timeline
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C,F,T
Product Registration Routes

Class I, IIa, IIb, III

Regular Track

Fast Track

Registration
Useful Information

Validity of License: 10 years.

 

License transfer: Not possible.

 

Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.

Infomation

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