The article provides an overview of the guidelines issued by the Ethiopian authority concerning the way medical devices should be placed on the market.
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published the guidelines for marketing authorization of medical devices. The document constitutes the fourth version of the guidelines and is intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the applicable legislation, as well as recommendations to be considered when placing medical devices on the market under the existing regulatory framework. The scope of the guidance covers all the key points associated with medical devices and the way they should be regulated including, inter alia, such aspects as:
- Principles of medical devices classification;
- Medical devices grouping;
- Borderline medical devices;
- Essential principles of safety and performance;
- Medical device conformity assessment;
- The application process, and others.
According to the applicable legislation, any medical devices manufactured, imported, exported, stored, distributed, transported, sold, held, used, or transferred to any other person in the country shall be registered and granted marketing authorization. Thus, all the parties involved in operations with medical devices should achieve and sustain compliance with the applicable requirements in terms of standards and procedures.
The present document is intended to provide additional clarifications and recommendations regarding the procedure to be followed when applying for marketing approval for a medical device based on its type. The aspects covered by the guidelines include the ones related to the classification principles and registration procedures for different types of medical devices including both general and in vitro diagnostic ones. Apart from this, the document provides an overview of the procedure followed by the authority when reviewing the application for registration; as well as special pathways for low-risk or vitally important medical devices intended to reduce the time and regulatory burden associated with placing such products on the market.
The authority also mentions that provisions of the present guidelines are based on recommendations issued by various international institutions including the European Commission, International Medical Device Regulation Forum (IMDRF), and Competent National Regulatory Authorities.
First of all, the document provides definitions of the most important terms and concepts used in the context of registration and marketing approval including, inter alia, the following ones:
- Medical device grouping – a systematic bundling or grouping of medical devices based on different criteria to make a single registration application for similar products.
- Trade name – a proprietary or brand name given by a company for marketing its product.
- The virtual manufacturer stands for the one that places on the market the product initially created by another manufacturer (original equipment manufacturer or OEM) by the specifications for a product that has been already registered and allowed for marketing and use.
- Authorized local agent (representative) stands for an entity authorized by the medical device manufacturer to act on behalf of the latter and represent it in relationship with the authority.
- Marketing authorization stands for issuance of certificate for the marketability of a medical device after full or abbreviated assessment of the provided supporting documents and other evidence by the Authority. It is important to mention that the terms “marketing authorization” and “registration” are interchangeable for this guidance.
- Conformity assessment is a set of steps undertaken to validate the safety and effectiveness of a medical device in question, as well as its conformity to the applicable essential principles.
- Clinical evaluation – the review of relevant scientific literature and/or the review and assessment of data collected through clinical investigation.
- Clinical investigation – designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.
The scope of the guidance covers general and in vitro diagnostic medical devices intended to be marketed and used in the country.
As it was mentioned before, the present document is intended to provide a general overview of the applicable legislation and regulatory requirements set forth therein while in specific cases manufacturers should refer to other guidance documents dedicated to the respective matters. The authority explicitly states that recommendations provided in the guidance are not exhaustive, nor cover all the aspects associated with the registration of medical devices. Furthermore, the authority reserves the right to modify the document to the extent necessary to reflect respective changes in the underlying legislation.
General Principles: Classification in Brief
These guidelines are based on provisions of the applicable legislation including the country’s laws, as well as regulations, directives, and guidelines issued by the authority.
Under the general rule, an entity interested in placing a medical device on the market should submit a complete application that meets any requirements. At the same time, certain deviations could have the place, provided they are duly justified. The EFDA also reserves the right to request an applicant to provide additional information, should it be reasonably necessary to review the submission and assess all the aspects related to the safety and effectiveness of a medical device subject to review. The general principles described herein are applicable for all medical devices irrespectively of their type.
The existing regulatory framework employs risk-based classification of medical devices. Hence, the level of regulatory scrutiny to be applied, as well as the scope of conformity assessment procedures required should be determined depending on the class of a medical device subject to review under the aforementioned classification. The authority states that such an approach constitutes a generally accepted practice and is adopted by national regulating agencies in numerous countries.
As it was mentioned before, the regulatory burden should correspond to risks associated with a medical device. Furthermore, it is not economically feasible or justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. Therefore, the authority has developed a graduated system of control that permits levels of controls that correspond to the level of potential hazard inherent in the type of device concerned. These levels of control depend on the appropriate medical device classification that is linked with device safety and performance.
Hence, the overall purpose of a risk-based classification system for medical devices is to ensure that the level of regulatory scrutiny corresponds to potential risks associated with the product when used for its intended purpose in the respective use environment.
According to the existing classification, all medical devices (including in vitro diagnostic ones) are divided into four classes depending on the risks associated thereto, namely:
- For general medical devices, the classes are Class I, II, III, and IV; while
- For in vitro diagnostic medical devices the classes are Class A, B, C, and D respectively.
In summary, the present guidelines issued by the EFDA provide an overview of the existing regulatory framework for marketing approval. The document outlines the key points to be taken into consideration when applying for registration of a medical device intended to be marketed and used in Ethiopia.
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