The new article provides an overview of the exemption rules to be applied when considering the applicability of the medical device registration rules.
Table of Contents
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for marketing authorization of medical devices. The document provides a detailed overview of the procedures to be followed when placing new medical devices on the market. In particular, the guidance provides clarifications regarding the way respective legislation should be interpreted and applied, as well as recommendations to be followed by medical device manufacturers and other parties involved. However, provisions of the document are non-binding in their legal nature, and the authority reserves the right to amend them from time to time to reflect the changes to the underlying regulations.
Exemption From Registration: Key Points
Under the general rule, any medical devices intended to be marketed in Ethiopia are subject to regulation by the EFDA. At the same time, applying a strict regulatory burden is not reasonably necessary for some of the products with the low risk associated with their use. Hence, to ensure the efficiency of regulatory processes and procedures, certain exemptions have been introduced. A similar approach could be applied concerning medical devices already approved for marketing and use by foreign recognized regulatory agencies applying the same level of regulatory scrutiny. Consequently, such products could be placed on the country’s market under the simplified procedure based on a limited scope of assessment to reduce the level of efforts for the parties involved.
Apart from this, registration is not required for:
- Custom made & personal use devices;
- Devices for national health emergency;
- Investigational devices;
- Devices for research, demonstration, training, education, and other non-clinical uses.
The document also refers to separate guidance dedicated to a special regulatory framework for the importation of vitally important medical devices. In general, special pathways are intended to reduce the unneeded regulatory burden and accelerate the process of placing new medical devices on the market while ensuring their safety and effectiveness. However, the authority also mentions that the devices subject to exemption still should not be placed on the market without prior approval.
Application Review: Basics
The document further describes the approach to be applied by the regulating authority when reviewing an application for marketing approval about a medical device intended to be supplied and used in Ethiopia.
According to the existing framework, such an application should be submitted electronically via the appropriate portal using login credentials to be communicated by the authority. The documents should be submitted in PDF format.
The whole review process consists of two stages, namely:
- Screening, during which the authority conducts a preliminary assessment to ensure that the application is complete and admissible for the respective pathway; and
- Evaluation, during which the authority conducts an in-depth review of the documents provided by the applicant to ensure compliance with the respective regulatory requirements to the product in question is subject.
In general, the authority employs a risk-based approach whereby the level of regulatory scrutiny depends on the risks associated with the device.
The document further describes in detail each of the aforementioned stages of the review process.
Screening
As it was mentioned before, in the course of screening, the authority examines the completeness of the application submitted for review. In particular, the authority checks whether all the documents required under the applicable framework are in place. The main purpose of this step is to identify whether any of the important parts of information necessary for review are missing. Such an approach allows EFDA to focus on complete submission and apply resources more efficiently.
Assessment
During the second stage, the authority performs a rigorous assessment of the technical documentation submitted to evaluate whether the medical device in question meets the applicable safety and performance requirements the product of this type should meet based on its class under the existing risk-based classification, intended use, and other specific features. Hence, the scope of the review will depend on the particular framework under which the application has been submitted. The authority’s staff included in the review is comprised of various specialists having the necessary experience and qualifications. Depending on the framework, an application could be assigned for review to one or two assessors, while the final review is to be performed by a team leader.
The assessment the authority performs is based on the existing regulatory framework, as well as the applicable standards. In the course of the review, the responsible person outlines the scope of information that is necessary to assess the appropriate aspects related to the safety, performance, and quality of a medical device, and then determines the parts of information that could be collected at a later stage – in the course of post-approval studies. The authority also reserves the right to request additional information, should such information be reasonably necessary to complete the review. According to the existing procedure, the authority completes the review using the information initially provided by the applicant and then creates a list of questions referring to the details that are still missing and sends it to the applicant. Each such request for additional information has a pre-defined timeline for the response to be provided by the applicant. Should the information provided by the applicant be found sufficient to complete the review, the authority will make the appropriate decision and issue a market authorization certificate.
Market Authorization Certificate
Under the general rule, a medical device could be allowed for marketing and use in the country only provided there is a valid market authorization certificate issued by the EFDA, except in the cases when the device in question falls within the scope of an exemption as described hereinabove. As further explained by the EFDA, a marketing authorization is composed of:
- A decision granting the marketing authorization issued by the authority; and
- A technical dossier with the data submitted by the applicant under the relevant authority’s regulatory requirements.
A market authorization certificate can be issued based on the complete application containing all necessary technical documentation by the respective regulatory requirements. The appropriate application could be also submitted by an authorized representative of a medical device manufacturer (its local agent).
In summary, the present EFDA guidance highlights the main principles for applying for exemption from registration concerning certain medical devices that meet the appropriate criteria. The document also describes in detail the process of review of the application for marketing approval which is required for a medical device to be allowed for marketing and use in Ethiopia.
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