Medical Device Registration Egypt

Medical Device Registration in Egypt: An Overview

Medical device registration is a crucial step for manufacturers and distributors to gain market access in Egypt. This process ensures that medical devices meet the necessary safety, quality, and efficacy standards set by the Egyptian Regulatory Authority (EDA). By registering medical devices, companies demonstrate their compliance with the regulations and gain the confidence of healthcare providers and patients. 

What is the Regulatory Authority to Register Medical Device in Egypt?

Egypt’s regulatory authority for medical device licensing is the Egyptian Drug Authority (EDA), which reports to the Ministry of Health and Population. The EDA enforces Egypt’s regulatory framework for medical devices, which includes Law No. 10 of 2003 and related executive rules. Manufacturers and distributors must understand and follow the unique regulations and recommendations established by the EDA.

Egypt’s promotion of medical device production has increased significantly, as the country’s healthcare and medical device industries flourish.

How Operon Strategist Can Help You with Medical Device Registration in Egypt?

Operon Strategist specializes in helping manufacturers navigate Egypt’s medical device registration procedure. Our expert team assures correct paperwork, regulatory compliance, and proactive help throughout the application and post-registration process. You can rely on us for efficient support and quick market access.

What is the timing for registering medical devices in Egypt?

The timeline for medical device registration in Egypt varies depending on the complexity of the device and the regulatory authority’s workload. To avoid delays, prepare the registration process ahead of time. Manufacturers should know the registration fees, including application and annual renewal payments.

How Can I Register a Medical Device in Egypt?

To register a medical device in Egypt, gather the necessary documents, which should include product information, technical specifications, and clinical data if appropriate. Send the registration application and complete dossier to the Egyptian Drug Authority (EDA) for examination and evaluation.