devices Archives - Registitute https://www.registitute.com/tag/devices/ Know How In Action! Sun, 06 Jul 2025 11:44:44 +0000 en hourly 1 https://wordpress.org/?v=6.2.8 https://www.registitute.com/wp-content/uploads/2023/04/fav-icon-150x150.png devices Archives - Registitute https://www.registitute.com/tag/devices/ 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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]]> Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices https://www.registitute.com/guidelines-for-conducting-clinical-trials-with-investigational-products-and-medical-devices-2017/?utm_source=rss&utm_medium=rss&utm_campaign=guidelines-for-conducting-clinical-trials-with-investigational-products-and-medical-devices-2017 Thu, 27 Apr 2023 03:58:03 +0000 http://www.registitute.com/?p=5814 These Guidelines applies to all clinical trials conducted in the United Arab Emirates. It does apply
to interventional, non-interventional studies including medical devices.

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These Guidelines applies to all clinical trials conducted in the United Arab Emirates. It does apply to interventional, non-interventional studies including medical devices. download the full document and contact us if you have any question.

Download The Document

The United Arab Emirates has established comprehensive guidelines to ensure the ethical and scientific integrity of clinical trials involving investigational products and medical devices. These guidelines apply to all clinical studies conducted within the UAE, including both interventional and non-interventional trials.

Whether you are conducting a pharmaceutical trial, evaluating a new medical device, or launching a post-market clinical follow-up study, adherence to the national regulatory framework is essential.

Who Should Use These Guidelines?

These guidelines are designed for:

  • Clinical researchers and investigators

  • Medical device manufacturers

  • Pharmaceutical companies

  • Contract Research Organizations (CROs)

Academic and research institutions operating in the UAE


Scope of the Guidelines

The document outlines standards for:

  • Ethical approval and informed consent

  • Study design and methodology

  • Risk management and patient safety

  • Good Clinical Practice (GCP) adherence

  • Regulatory submissions for both drugs and medical devices

It also covers investigational medical device trials, a growing area of innovation and regulatory attention in the UAE.

Why Compliance Matters

Ensuring your study complies with UAE regulations:

  • Speeds up the approval process

  • Enhances credibility with regulatory authorities

  • Reduces delays due to non-compliance

  • Promotes patient safety and data integrity

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]]> Technical File Assessment (TFA) for Medical Devices in Saudi Arabia https://www.registitute.com/how-to-go-about-intiating-an-start-up/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-go-about-intiating-an-start-up Wed, 26 Apr 2023 11:01:00 +0000 https://www.registitute.com/?p=6942 These Guidelines applies to all clinical trials conducted in the United Arab Emirates. It does apply
to interventional, non-interventional studies including medical devices.

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Whether you’re a medical device manufacturer, Authorized Representative, or a distributor in Saudi Arabia, you’re undoubtedly familiar with the stringent medical devices’ registration requirements set forth by the Saudi Food and Drug Authority (SFDA). All devices now, from low to high-risk classes, must be submitted through Medical Device Marketing Authorization (MDMA) with a full TFA procedure.

In this article, we’ll guide you through all requirements of the TFA process to ensure that your submission meets SFDA standards and garners swift approval. So, let’s dive in and get started! </br>

 

TFA

The TFA is a pivotal step in the registration of medical devices in Saudi Arabia, mandating the submission of exhaustive documentation to prove conformity with national regulations, essential principles, and applicable standards. This entails providing comprehensive information about the design and manufacturing facilities, including critical subcontractors, as well as device specifications. Subsequently, applicants must furnish a detailed account of the materials employed, assembly processes, sterilization methods, labelling requirements, and other manufacturing information.

Furthermore, the quality management system must be demonstrated through documents like audit reports as well as certifications. In addition, a benefit-risk analysis and strategies for post-market surveillance, including vigilance reporting procedures, must be provided.

Finally, the declaration of conformity must assert the accuracy of all relevant documentation. The submission of a complete and accurate Technical File is essential for timely SFDA approval of the medical devices.

Required Documents

Central to the TFA by the SFDA is the inclusion of vital documents that establish evidence of compliance with national regulations, standards, and guidelines. While the required documents may vary depending on the type of medical device being registered, manufacturers should provide common documents such as product specifications including intended use and indications for use, labelling information comprising instructions for use, warnings, and contraindications, manufacturing process details that encompass design drawings and production flow diagrams, and risk assessments to identify potential hazards associated with the product.

Additionally, manufacturers must provide clinical evaluation reports that demonstrate how they have assessed the safety and performance of the device in a clinical setting before releasing it to the market.

Eventually, verification/validation studies are critical, demonstrating that the device satisfies applicable regulations or standards.

A prepared set of these documents streamlines the registration process, while also ensuring compliance with SFDA’s regulatory requirements for medical devices in Saudi Arabia.

“The below diagram shows the needed documents for the registration of medical devices in Saudi Arabia. Please contact us today and ask about our ready-made-checklist for TFA, and check the feasibility of introducing your medical device into Saudi Arabia market.” Contact Now

Design/Manufacturing facilities and Critical Subcontractors Information
Manufacturing facility details must include the location, size, and layout, and any relevant certifications or accreditations held by the company.
All critical subcontractors involved in the production process must be identified.
Manufacturing processes in details; such as product design, testing protocols, and final inspection procedures.
Devices and Accessories Information
Detailed information about your device and its accessories. The SFDA requires exhaustive specifications for every aspect of your product, including its design and manufacturing processes.
Furthermore, as part of the TFA, technical drawings or schematics for each component may be required to illustrate how they fit into the overall design of your product.
Design and Manufacturing Information
Design and Manufacturing Information; describing the device's design, its intended use, and how it was manufactured, description of the product's components, materials used in construction, and any manufacturing processes employed during production, details about equipment utilized in production and quality control measures implemented throughout each manufacturing stage, and device's design specifications.
Quality Management System
A comprehensive QMS that encompasses all aspects of design, manufacture, packaging, labeling, storage, and distribution is mandatory for SFDA approval. It must include policies for document control, corrective and preventive actions (CAPA), risk management strategies, and training programs. Regular internal audits are also required as part of the QMS, to identify any non-conformances or areas for improvement.
Essential Principles Checklist and Conformance Evidence
Essential Principles Checklist is an important component of this process, which outlines the fundamental requirements for medical devices to be sold in Saudi Arabia, such as design, manufacturing processes, labeling, instructions for use, risk management, and clinical evidence. Applicants must provide Conformance Evidence to demonstrate compliance with these principles.
Benefit-risk Analysis and Risk Management
Benefit-risk analysis and risk management are critical components. Risk management should involve identifying hazards related to the device use, assessing those risks in terms of probability and severity, and implementing appropriate controls to reduce or eliminate risks throughout the device's lifecycle. Comprehensive documentation that demonstrates how both analyses were conducted is required for SFDA approval.
Product Verification and Validation
Manufacturers must submit detailed reports on their verification and validation activities, including information on test protocols used and data analysis methods employed during testing.
Vigilance and Post Market Surveillance
Manufacturers must establish a comprehensive system for monitoring the safety and performance of their devices after they have been placed on the market. Manufacturers must report serious incidents to the SFDA promptly and conduct periodic safety reviews of their products.
Take the first step to get your medical device approved and Contact Us today to learn more about our medical devices’ registration services in Saudi Arabia!

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