Greetings from
Freyr Egypt
Obtaining market approvals in Egypt would require compliance with the regulations of Central Administration of Pharmaceutical Affairs (CAPA), a division of the Egyptian Ministry of Health. To navigate through the registration and approval procedures, manufacturers should require an authorized representative in the region besides being updated with the region’s Regulatory requirements.
Freyr’s Regulatory consulting for Egypt includes strategic advice on Regulatory submissions for:
Industries We Serve in Egypt
Egypt’s burgeoning demand for medicinal products due to demographic growth and urbanization makes it one of the top markets in Middle East and Africa. All drug products are required to be approved by the Egyptian Drug Authority before distribution or marketing in the country. From decoding the Regulatory framework to aligning with the Regulatory requirements, being compliant with Egyptian Drug Authority might be a tedious task for new market entrants. Added to that, eCTD conversions, Active Pharmaceutical Ingredient designs and other Regulatory processes might require a special attention in order to adhere to the stringent regulations.
Since September 2018, medical device registration has become mandatory in Egypt. The medical device industry in the country has witnessed consistent growth, rendering an appealing market for manufacturers and distributors. With a valuation of $4.0 billion in 2021, the Egyptian medical devices market is projected to achieve a Compound Annual Growth Rate (CAGR) of over 3% from 2022 to 2027. Importation largely fulfills the demand for medical devices in Egypt, given the relatively low local production. Remarkably, the Egyptian medical devices market stands as the second largest in the Middle East and North Africa (MENA) region. This overview explores key aspects of the Egyptian registration process, offering insights into the Regulatory framework and requirements for bringing innovative medical devices to the forefront of Egypt's healthcare sector.
Freyr Offerings
- Strategic Regulatory Consulting
- Health Authority interactions
- Registration and license management services
- Dossier management
- End-to-end Regulatory submissions
- Regulatory labeling and artwork services
- MOH follow-up
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with Ministry of Health
- Expert Regulatory team with proven track records
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines