The Egyptian Drug Authority (EDA) has published the updated Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices Holding International Quality Certificates (Code: EDREX: GL.CAMD.002, Version 2.0, effective September 2025). This guideline defines the regulatory framework, procedures, documentation requirements, and evaluation pathways for registering medical devices in Egypt that already hold recognized international quality certificates such as CE/ISO 13485:2016.

Objective & Scope

The purpose of the guideline is to standardize the registration process for imported and locally manufactured medical devices that are certified according to internationally recognized quality systems, enhancing efficiency, transparency, and compliance with safety and quality standards. It applies to devices imported into Egypt and those manufactured locally that hold international quality certificates (e.g., CE and ISO 13485).

Definitions and Applicability

The guideline begins with regulatory definitions for key terms:

• Medical Devices: Any instrument, software, implant, or material intended for medical purposes, excluding products whose primary effect is pharmacological.
• Imported Medical Devices: Devices manufactured abroad and intended for sale and use within Egypt.
• Locally Manufactured Medical Devices: Devices produced in Egyptian facilities.
• International Quality Certificates: Typically recognized certifications such as CE marking and ISO 13485:2016 quality management systems.

Registration Procedures and Tracks

The guideline provides structured procedures for device registration, including distinct workflows depending on device type and completeness of documentation. Key elements include:

1. Normal and Fast-Track Registration
   Devices may be submitted via a normal track (standard review timeline), or a fast-track process for prioritized evaluation.
   Upon submission through the EDA’s online platform (medevice.edaegypt.gov.eg), the application is reviewed for completeness within specified time frames (e.g., 5 working days for normal track).
   If accepted, the file proceeds to technical and regulatory assessment.
2. Initial Registration File and Acceptance Numbers
   For devices where complete documentation is not ready at initial submission, the applicant may submit an initial registration file containing core certificates (e.g., Declaration of Conformity, CE certificate, ISO 13485, free sale certificates).
   The authority may grant a temporary acceptance number and a defined grace period (e.g., 18 months) to complete the full registration file.
   During this period, the applicant is required to submit the remaining technical dossier via the online portal to obtain a permanent acceptance number and continue full evaluation.

Device Classification and Specific Procedures

The guideline distinguishes between sterile and non-sterile devices and applies different documentation workflows accordingly:

• Scientific Committee Review: Complex devices may be reviewed by specialized scientific committees (e.g., for biocompatibility or stability assessments) as part of the regulatory evaluation.
• Safety and Vigilance Requirements: Device safety obligations for manufacturers and importers are defined, including reporting of defects or hazards.ep-by-step evaluation paths and timelines for each category.

Issuance of Registration License and Re-Registration

• Upon successful technical and regulatory evaluation, the EDA issues a registration license, authorizing market entry and legal distribution in Egypt.
• The guideline outlines procedures for re-registration, renewal, and amendments to the registration license.mport cases (e.g., donations, personal use)

Documentation and Annexes

Several appendices detail the specific lists of required documents for different device categories and evaluation scenarios. These include:

• Lists of documents for sterile medical device registration
• Lists of documents for non-sterile devices
• Additional requirements for devices evaluated by scientific committees
• Commitments related to device safety obligations under Egyptian regulation

Conclusion

The EDA’s Version 2 Regulatory Guideline on registering medical devices with international quality certificates represents a structured, risk-based, and internationally aligned regulatory framework for device entry into Egypt. By integrating procedures for both complete and partial registrations, scientific evaluation pathways, and documentation checklists, the guideline enhances regulatory clarity and supports efficient evaluation while maintaining safety and quality oversight.