Guidelines for “Registration Requirements of In Vitro Diagnostic Medical Devices”
In order to fully understand EFDA’s comprehensive registration requirements and make request for the Marketing Authorization of In vitro diagnostic medical devices, I recommend you to download and read the guideline that is attached below (in PDF format).
Here, I am just providing you the introduction and a brief summary of the guideline:-
Ethiopian Food and Drugs Authority is the national regulatory authority responsible to regulate food, medicines, medical devices, cosmetics and other health products mandated by Ethiopian Food and Medicine Administration Proclamation No: 1112/19. The regulated products including medical devices follow various regulatory processes from their premarket assessment to post-market control in order to protect the public health by ensuring the safety, performance and quality of the products. One of the EFDA’s premarket assessments is to evaluate the product dossiers of the medical devices. This guideline is therefore intended to provide a comprehensive and well-organized structure for premarket In Vitro Diagnostic Medical device submissions that assists the manufacturers to submit uniform registration dossier when registering their products.
This document provides harmonized, modular, format for use when filing In Vitro Diagnostic medical device submissions to EFDA for market authorization.
The outline of documentation is to support a smooth documentation process. It remains the applicant’s responsibility to ensure all regulatory requirements are met, and that clear and transparent evidence of conformity to these requirements are provided.
Manufacturers of all classes of medical device are expected to demonstrate conformity of the device to the Essential Principles of Safety and Performance (EPSP) through collection and examination of evidence of conformity in technical documentation that shows how each medical device was developed, designed and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity. This technical documentation must be updated as necessary to reflect the current status, specification and configuration of the device.
The evidence of conformity of medical device to the EPSP must be compiled and submitted as per the requirements set in this guideline for the purpose of conformity assessment and submission of application for medical device registration. The compiled documents need to be kept in the premise for audit or inspection purposes.
The EFDA will monitor the use of these structures and work to continually improve the documents at appropriate intervals based on sufficient use and experience.
What the guideline covers
This Guideline is applicable for registration of In-vitro diagnostic Medical devices. It does not apply to medical devices listed under the “Guideline for Marketing authorization of Low Risk Medical Devices”. The Medical devices other than In Vitro diagnostic medical devices are also not in the scope of this guideline as these devices have separate guideline stipulating requirements for their registration.
The guideline for Registration Requirements of In Vitro Diagnostic Medical Devices is attached below and you can download and read to understand the requirements in detail.