The present article describes in detail the aspects related to the Ethiopian classification rules for both general and in vitro diagnostic medical devices, as well as the criteria for medical devices grouping when applying for marketing authorization.
The Ethiopian Food and Drug Authority (EFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the marketing authorization of medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory framework, and also recommendations to be considered by medical device manufacturers and other parties involved in placing new medical devices on the Ethiopian market. In particular, the document describes in detail the procedures related to applying for marketing approval, including the matters related to the classification of medical devices to determine the level of regulatory scrutiny and specific requirements to be followed.
Classification for General Medical Devices
Under the general rule, classification for medical devices depends on the risks associated with the device when used for its intended purpose, and also on the technologies used. As further explained by the EFDA, the factors to be considered in this respect include, inter alia, the following ones:
- Whether the device is life-supporting or sustaining;
- Whether it is invasive and if so, to what extent and for how long;
- Whether it incorporates medicinal products, or human/animal tissue/cells;
- If it is an active medical device;
- If it delivers medicinal products, energy, or radiation;
- Whether it could modify blood or other body fluids; and
- Whether it is used in combination with another medical device.
The existing classification system covers all types of medical devices and prescribes specific rules to be applied depending on the nature of the device in question and its features.
Based on the factors described hereinabove, all medical devices could be divided into four classes from I to IV where Class I stands for the lowest risk, and Class IV for the highest respect. The authority also mentions that there is a separate guidance document that addresses classification rules for general medical devices.
Classification of IVD Medical Devices
The scope of the present guidance also covers the classification rules to be applied concerning in vitro diagnostic (IVD) medical devices. According to the guidance, the classification of such products should be based on the following aspects:
- The initial intended use of the device and indications for the use specified by its manufacturer;
- The level of knowledge of potential users (e.g., whether the device is intended to be used by healthcare professionals or laypersons);
- The way the information to be provided by the device will be used in a decision-making process; and
- The way the testing results provided by the device could impact the health and safety of an individual or public health in general.
As in the case with general medical devices, four classes should be applied where Class A corresponds to the lowest risk, and Class D to the highest respect.
Medical Devices Grouping Criteria
Apart from classification rules, the guidance also describes the medical devices’ grouping in the context of marketing authorization applications. According to the guidance, the principles of medical devices grouping is concerned with determining whether certain medical devices can be included together and submitted in one product marketing authorization application. The concept of grouping is intended to reduce the regulatory burden, as well as the regulatory efforts related to placing new medical devices on the market since it allows the application for marketing authorization for several medical devices by submitting a single application.
The authority also mentions that according to the applicable legislation, any medical devices intended to be marketed and used in Ethiopia should be subject to prior registration with EFDA, except in the cases when they meet exemption criteria set forth by the respective regulations. Depending on the nature and intended use, medical devices could be supplied either as separate products or in combination with other devices and products. For instance, they could be supplied as convenient all-in-one kits or individually customized packs. Moreover, even the products that are intended to be supplied separately, could be available in various configurations. Specific characteristics could be also applied depending on the nature of the device in question and its features.
To streamline the review process, several medical devices could be bundled and submitted together by the respective grouping criteria. The authority mentions that additional clarifications on this are provided in the Guidelines for General Grouping of Medical Devices and Guidelines for Device-Specific Grouping. These guidelines describe the way medical devices could be grouped within a single application as follows:
- Single medical device;
- Medical device family;
- IVD Cluster;
- IVD Test kit.
Thus, medical device manufacturers applying for marketing authorization for their products should determine the particular approach to grouping to reduce the regulatory burden and simplify the process.
Borderline Medical Devices
The document pays special attention to the regulatory matters related to borderline cases – the ones that are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, or not. This also applies to the situations when the product in question meets the definition of a medical device but at the same time is explicitly excluded from the scope of respective regulations. In such cases, to determine the regulatory status of such products, one should evaluate the primary mode of action of the product (the way it causes effect), and also the claims made by the manufacturer about the functions and features of the product. The authority mentions that under the general rule, medical devices achieve their functions by the device of physical action, even though for certain devices their function could be supplemented by medicinal substances, provided that the action caused by such substance is ancillary to the one caused by the device itself.
Thus, the authority encourages medical device manufacturers to familiarize themselves with the respective guidance documents to ensure the correct determination of the regulatory framework to be applied.
In summary, the present EFDA guidance provides additional clarifications regarding the existing classification system for medical devices and describes its specific features. Additionally, the document provides the details regarding the grouping criteria, as well as the approach to be applied concerning borderline products.
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