Egypt regulatory update

The Egyptian Drug Authority (EDA) has recently published an update to the Egyptian registration process for Medical Devices and IVD. This guideline is about Preclinical testing and Clinical Investigation for Medical devices.

Please contact us if you need support with Egyptian registration of your medical devices or IVD products.

Guideline for Preclinical testing and Clinical Investigation for Medical devices

EDA launched a new document in October 2024 regarding the design of preclinical and clinical studies intended to support clinical development for medical devices. It describes the rules around the conformity assessment of the Investigational Medical Device (whereby the medical devices or IVD manufacturers demonstrate to EDA that its medical device complies with local regulation and EDA guidelines). 

The conformity assessment involves the following: 

• Technical documentation for the design of the devices;

• Manufacturing processes used to make the devices;

• Risk analysis; 

• Clinical evidence; 

• Ongoing monitoring and vigilance procedures that will be in place once the device is available for supply.

The document provides guidance to those involved in designing pre-clinical and clinical studies intended to support clinical development for medical devices. 

The guideline applies to: 

1. Locally manufactured medical devices; 

2. Imported Medical devices with no granted international quality certification (e.g.: CE mark in EU MDR, 5(10)K or PMA in FDA);

3. Medical devices already on the market (either with international quality certification or not) that are being evaluated for new intended uses, new populations, new materials or design changes; 

4. Any other cases that require preclinical and clinical testing for medical devices and IVDs as per EDA regulations and NRA opinion/ requirements.

   
   

The guideline also includes principles that are applicable to combination products (being devices containing ancillary products such as drugs, biologicals, etcetera) and software as a medical device (SaMD).

The guideline will provide a comprehensive overview for six main sections related to investigational medical devices, as a part of the conformity assessment process: 

1. Medical devices classification and types of clinical evidence;

2. Requirements for preclinical or non-clinical investigations and animal studies in medical devices;

3. Requirements for clinical investigations in medical devices; 

4. Ethical considerations for clinical studies in medical devices; 

5. Risk Management for medical devices;

6. Safety reporting in clinical investigations of medical devices. 
   

Although a great deal of emphasis is placed on the importance of clinical data in demonstrating the safety and effectiveness of a medical device, non-clinical data also can be critical to understanding a device’s safety and effectiveness. Medical devices often have attributes that cannot be tested using clinical methods alone that play a major role in the safety or effectiveness of the device. Both clinical and non-clinical testing methods may be used to assess the probability or severity of a given risk, and/or the success of risk mitigation.

Further details on the guidelines can be found using this link: https://www.edaegypt.gov.eg/media/lm0odsj1/guide-line-medical-deviece-guideline.pdf 

Registration guidelines for medical devices in Egypt can be complex and difficult to interpret. Next to that, guidelines change and knowing the latest status can impact the registration process from a cost and timing point of view. Gateway MedTech has the experts to guide you through the process efficiently to assure your go-to-market is not delayed.

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