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EGYPT Medical Device Regulations

EGYPT Medical Device Regulations

Navigating Medical Device Registration in Egypt: A Comprehensive Guide through EDA Regulations and Market Trends

Updated on 26/01/24

Regulatory Authority: Egyptian Drug Authority

The Egyptian Drug Authority (EDA) is an initiative for an organization within the Ministry of Health that is responsible for safeguarding people health by regulating safety and quality of medicines (human and veterinary), biologicals, medical devices, cosmetics, dietary supplements, and pesticides. The EDA has three sub-organizations that work cooperatively and synergistically to assure the achievement of the EDA mission CAPA, NODCAR & NORCB.

The Egyptian Drug Authority (EDA) regulates pharmaceutical products, ensures safety and quality, and provides affordable medicines. It sets standards for pharmaceutical services, coordinates product registration and market monitoring, raises public awareness about medicines, supports pharmacy education, and collaborates with international organizations like the WHO.

Link for Regulatory Authority: https://www.edaegypt.gov.eg/en/

Local Regulation:

  • Medical Device Regulations Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants
  • Law No. 151 of 2019

Law No. 10 of 2003

Classification:ClassI, IIa, IIb, III
IVD Devices: Devices for self-testing, Annex II List A or List B

Listing or Registration Requirements:

  • All medical devices must be registered with CAPA (Central Administration of Pharmaceutical Affairs) and obtain the Marketing Authorization.
  • Manufacturers with no local presence in Egypt must appoint an Egyptian Registration Holder.

Documents Required for Registration:

  • CE Certificate
  • Declaration of Conformity Certificate
  • ISO Certificate
  • FSC
  • Letter Of Authorization

Registration Timeline: 6 – 12 Months

Registration Fee:

  1. Evaluation/Examination of an Imported Medical Device Registration File:

Normal Track: $98, Fast track Registration: $421

  1. Registration of non-sterile Medical Devices using the Bundling system: (Medical Devices are divided into groups).
  • From 2 to 10 devices, Normal Track: $226.52, Fast Track: $711.93.
  • From 11 to 20 devices, Normal Track:291.24, Fast Track: 776.65.
  • From 21 to 30 devices, Normal Track: 355.97, Fast Track: 841.37.
  • From 31 to 40 devices, Normal Track: 420.69, Fast Track: 906.09.
  • From 41 to 50 devices, Normal Track: 485.41, Fast Track: 970.81.

License Validity: 10 Years

Language Requirements:Home use labelling must be provided in Arabic and professional use labelling must be provided in English.

Who should make this communication:

  • Manufacturer
  • Authorised Representative

When to make this communication: Before placing a medical device into the market

Market of Medical Devices:

The Medical Devices market in Egypt is poised to attain a revenue of US$1,142.00 million by the year 2024. Among the diverse market segments, US$159.80 million is projected to capture the largest market share in the same year. Anticipating an impressive annual growth rate of 12.17% (CAGR 2024-2028), the market is forecasted to reach a substantial volume of US$1,808.00 million by 2028.

It is noteworthy that on a global scale, the United States is expected to lead with the highest revenue, reaching US$182.00 billion in 2024. Egypt is currently witnessing a surge in demand for advanced medical devices, driven by the increasing healthcare needs of its population.

How OMC Medical can assist you with the process:

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]