Registration Archives - Registitute https://www.registitute.com/tag/registration/ Know How In Action! Sat, 19 Aug 2023 09:15:14 +0000 en hourly 1 https://wordpress.org/?v=6.2.8 https://www.registitute.com/wp-content/uploads/2023/04/fav-icon-150x150.png Registration Archives - Registitute https://www.registitute.com/tag/registration/ 32 32 Registration of Medical Devices in Egypt https://www.registitute.com/registration-of-medical-devices-in-egypt/?utm_source=rss&utm_medium=rss&utm_campaign=registration-of-medical-devices-in-egypt Sat, 19 Aug 2023 09:14:47 +0000 https://www.registitute.com/?p=7183 As a medical device manufacturer looking to access the Egyptian market, you must register your products with the Egyptian Drug Authority (EDA)

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Unleashing the Potential of Egypt's MedTech Market: Navigating the Rigorous Path to Success

As a medical device manufacturer looking to access the Egyptian market, you must register your products with the Egyptian Drug Authority (EDA) to legally import, promote and sell them in Egypt. The EDA is the regulatory body responsible for medical devices registration and marketing authorization. Successfully registering your devices requires navigating the EDA’s multi-step process, understanding the country’s regulatory requirements, and ensuring your submission dossier is comprehensive and compliant. Though the road to registration can be long, following the proper procedures and maintaining open communication with the EDA will help get your medical devices approved and available to patients and healthcare providers across Egypt. With a population of over 100 million and increasing demand for advanced healthcare, Egypt represents an attractive growth market for global MedTech companies.

Understanding the Egyptian Drug Authority (EDA)

The Egyptian Drug Authority (EDA) is Egypt’s regulatory agency responsible for the registration and approval of medical devices for commercial use. To register a medical device with the EDA, it is important to understand their regulations and procedures.

The EDA classifies medical devices into three risk-based classes according to their intended use and indications: Class I (low risk), Class IIa & IIb (medium risk), and Class III (high risk). The classification of your device will determine the registration pathway. Higher risk devices typically require more rigorous evaluation.

In line with Egypt’s Vision 2030 and strategy to establish the basis for digital transformation, and to complete the steps taken by the EDA to become a digital body, all of its services are digitally provided to facilitate the recipients of those services and to achieve a better vision for decision makers. Therefore, the EDA has launched the “MeDevice” platform on July 11th 2021 as a platform for medical devices importers, distributors and scientific offices to submit all their applications.

Medical Devices Registration
To register a medical device with the EDA, you will need to submit several documents to evaluate your device for safety, efficacy and quality before approving it for the Egyptian market.
All medical devices that are manufactured, imported or distributed commercially in Egypt must be registered with the EDA prior to being marketed or sold. This includes both disposable and reusable medical devices, as well as in vitro diagnostic medical devices.
Sterile Medical Devices Registration Process

For Sterile Medical Devices, products need to be submitted through “MeDevicce” portal where it should take around 3 to 5 working days to decide whether the file should be accepted to move on to the next step or if there are comments, this needs to be fulfilled prior to the next step. Once accepted, the file will move forward where it will be evaluated by: the scientific committee, vigilance department, and the stability committee. This evaluation should take around 7 to 20 working days (depends on whether the file is submitted via the normal or the fast track). The applicant should then ensure to respond to any comments raised by EDA within 60 working days otherwise the file could be rejected and the application will have to be re-submitted again as a new application. To summarize, below the steps that need to be taken to submit a registration file for a sterile medical device:

Submit through “MeDevice” portal with the required documents
If the EDA returned the application with comments; applicant needs to fulfil the comments raised by EDA. Applicant has 60 working days to fulfill the comments.
If accepted, it will go on to the next step for the final evaluation.
Once accepted, EDA will issue the registration license.
Non-Sterile Medical Devices Registration Process

For non-sterile medical devices (Class IIa, IIb and III), the applicant can either submit a full registration file and follow the same path applied to sterile medical devices or they can submit an initial registration file while following the below steps:

Declaration of Conformity

CE Certificate

ISO Certificate

Free Sales Certificate from the country of origin*

*for Class IIa devices. A Free Sales Certificate can be submitted from a non-reference country while ensuring that another certificate is submitted from a reference country within 6 months.

  • A temporary acceptance number shall be given to the file submitted by the EDA
  • The applicant shall then submit a full registration file within 6 months of obtaining the temporary acceptance number and 18 months to finalize the registration file and obtain the approval certificate
Non-Sterile Medical Device Bundling

As per the EDA’s guidelines, a group of non-sterile medical devices can be bundled together if the following criteria are met:

They have the same legal manufacturer, same classification, same generic proprietary name.
They have common intended use.
They have similar or close design.
They are within the scope of permissible variants that may be evaluated from the scientific committee.
The files submitted (Declaration of Conformity, CE Certificate, Free Sales Certificate and/or the Certificate of Foreign Government) mention that the products submitted are part of a medical device system.
The medical devices products in the system are not required to have the same: Raw Material, GMDN code or Patient Population.
If the above-mentioned criteria are approved, A specialized EDA committee will evaluate that application a medical device system for approval.
Scientific Committee Registration

There’s an additional road for the medical devices with the below specification. This is the Scientific Committee Approval pathway. it’s implemented for:

Locally manufactured medical devices.
Medical devices submitted for registration from a non-reference country.
To decide whether a group of medical devices submitted within the same registration file are different to a point that warrant splitting them into different registration files.
Medical devices that come in dosage forms.
For any application, If requested by the EDA’s vigilance department.
Vigilance Department

The EDA’s vigilance department is involved in the registration process of medical devices that are classified as Class IIb or class III. However, it could also be involved with Class Is and IIa medical devices if those devices require further regulatory action. The applicant needs to submit a declaration letter from the manufacturer and the applicant declaring to comply with the vigilance regulations set by EDA and to declare to report any global recalls, Field Safety Notices or Field Safety Corrective Actions to EDA while also reporting any incidents that occur in Egypt.

Renewal of the registered medical devices license

Medical devices registration licenses are valid for 10 years. The applicant is required to submit an initial request to renew/ re-register the licence during the first 3 months of the last year of the validity of the license.

Annex I: Medical Device Registration Required Documents for Submission

1. Payment receipt from the EDA for the medical devices to be registered
2. Authorization letter from applicant (Authenticated by the bank) to authorize the employee to submit the file and follow up with the EDA.
3. Declaration letter for the vigilance department.
4. Authorization letter from the legal manufacturer to the applicant that mentions the medical devices the applicant is allowed to submit for registration.
5. Commercial record for the applicant or a scientific office license in case the scientific office is the applicant.
6. Importer’s register’s license that mentions the manufacturer’s name.
7. Free Sales Certificate from the health authority of the country of origin (if the country of origin is a reference country) Or a Free Sales certificate from any reference country.
8. Certificate of Foreign Government (US). If provided, the applicant is not required to provide CE Certificate or ISO 13485 if the CFG mentions the following: “Plant at that time appeared to be in compliance with current good manufacturing practice requirements”
9. CE Certificate for the medical devices to be registered. (Not applicable for Class I Non-Sterile Medical Devices - For Class I Non-Sterile Medical Devices: Certificate of compliance with essential requirements and harmonized standards checklist.

10. ISO 13485 certificate from an accredited notified body
11. Declaration of Conformity from the legal manufacturer
12. Technical File of the medical devices to be registered containing the following:
a. Raw material composition
b. Certificate of Analysis.
c. Sterilization certificate(s).
d. Packaging materials and number of units.
e. Inner and Outer Labels.
f. Product Catalogue.
g. Product IFUs.
h. Shelf life for the products.
i. Medical Device Sample to be submitted physically to EDA.
Annex II: List of Reference Countries
• Belgium
• France
• Germany
• Italy
• Luxemburg
• Netherlands
• Austria
• Finland
• Sweden
• Norway
• Denmark
• Ireland
• United Kingdom
• Greece
• Portugal
• Spain
• Bulgaria
• Romania
• Cyprus
• Czech Republic
• Estonia
• Hungary
• Latvia
• Lithuania
• Malta
• Poland
• Slovakia
• Slovenia
• Australia
• New Zealand
• United States of America
• Canada
• Japan
• Iceland
• Switzerland

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