Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority, has published guidance dedicated to post-approval change notification for medical devices. The document constitutes the initial version of guidelines developed by the authority.
The document describes the categories of changes to medical devices already placed on the market and outlines the main regulatory requirements the modified devices should comply with to be allowed for further marketing and use in Ethiopia.
Regulatory Background
In accordance with the applicable regulations (namely – the Food and Medicines Administration Proclamation No. 1112/2019), if the changes made to the medical device already placed on the market could impact its safety, quality, and effectiveness, the device should not be made available for healthcare professionals and patients before notification and corresponding approval by the regulating authority.
The authority acknowledges that medical devices could be subject to changes during the period of time they are placed on the market. At the same time, irrespectively of the changes made, a medical device should still comply with any and all regulatory requirements related to safety and effectiveness. In order to ensure ongoing compliance with the aforementioned requirements and also the effectiveness of the risk management approach, all changes made to registered medical devices should be subject to additional approval. In this context, the authority would evaluate the impact caused by the changes to the safety and effectiveness of the device using the evidence collected and provided by the responsible entity. It is the sole responsibility of the medical device manufacturer to evaluate the impact the changes would have on patients and the specifications of the product to determine the actual impact they would cause on the device’s safety and effectiveness.
The regulatory approach employed by the EFDA and described in the present guidance is based on dividing changes into categories. The particular action to be taken by the manufacturer with regard to changes to the medical device would depend on the category to which such changes belong.
The scope of the document covers any and all medical devices allowed to be marketed and used in Ethiopia. The guidance covers the most important aspects to be considered by the medical device manufacturers making changes to their products that are already placed on the market. The requirements described herein should be applied irrespective of whether such changes are requested by the authority or implemented by the medical device manufacturer at its own initiative. The EFDA additionally mentions that the guidance should not be applied for medical devices that are still undergoing initial premarket review.
First, the document provides the definitions of the most important terms used in the context of changes to register medical devices. For instance, a “Change” stands for a post-approval variation to any aspect of a medical device, including but not limited to a change to method and site of manufacture, specifications for the finished product, components or raw material, container and container labeling, and product information. The document also provides the definitions of such terms as “Accessory”, “Cautions and precautions”, “Contradiction”, “Control mechanism”, “Facility”, “Indications for use”, “Indirect contact”, “Labelling”, “Operating principles”, “Recall”, and others.
Change Categorization Principles
As mentioned, the approach to changes to registered medical devices described in the guidance is based on the categorization of such changes. The categorization considers the impact caused by changes on the safety, quality, and performance of a medical device. Each change made to a medical device already placed on the market should be considered separately. In particular, the EFDA applies the following categories:
1. Category 1 changes – critical changes causing significant impact on the safety and effectiveness. In case of such changes, a new registration is required.
2. Category 2 changes – major changes requiring additional assessment and approval by the authority before the device will be made available for healthcare professionals and users.
3. Category 3 changes – minor changes are not associated with significant risk and thus could be implemented immediately without prior approval.
The responsible entity shall indicate the relevant category in the application. Should the authority disagree with the category indicated by the applicant, it will request to change it accordingly.
According to the document, in the case of Category 1 changes, entirely new registration of a medical device is required in case of changes to:
- The intended purpose of a medical device or its indications for use;
- The risk classification;
- Software impacting the safety and effectiveness of a medical device;
- The medical substance a combination product contains (its type, concentration, or drug specification).
The same applies in the case of the addition of medical devices with device proprietary names different from the registered devices, into a device listing, unless the devices with different proprietary names qualify to be registered together less than one listing based on medical device grouping criteria for medical devices registration, and also in case of addition of model(s) that do not fulfill the grouping criteria, including permissible variants, as listed in the Grouping of Medical Devices for Product Registration.
Assessment of Changes and Documents to be Submitted
The guidance also describes the procedure associated with the assessment of the changes, as well as the documents to be submitted by the entity responsible for the medical device in question. In particular, the guidance provides the list of documents to be provided for each type of change.
Type of Changes and Documents to be Submitted
Changes to manufacturing and/or sterilization facilities
1) Revised Quality Management System (QMS) certificate,
2) Labelling sample reflecting the changes,
3) Declaration confirming the changes are not related to manufacturing and sterilization process, and
4) Sterilization validation report.
Any changes to the control mechanisms, operating principles, and/or design characteristics.
1) Revised QMS certificate (if applicable),
2) Pre-clinical studies,
3) Risk analysis,
4) Clinical studies,
5) Labelling sample reflecting the changes,
6) Software validation report (if applicable), and
7) Detailed summary of software changes (if applicable).
Any changes to materials or material formulation (of non-biological origin), including changes to medical device coating or surface modification techniques, that involve materials that make direct/indirect contact with body tissues and fluids or are absorbed by the body.
1) Revised QMS certificate (if applicable),
2) List of patient-contacting materials,
3) Pre-clinical studies,
4) Clinical safety report (if applicable), and
5) Risk analysis.
Any changes to materials or material formulation (of non-biological origin), including changes to medical device coating or surface modification techniques, that involve materials that make direct/indirect contact with body tissues and fluids or are absorbed by the body.
1) Revised QMS certificate (if applicable),
2) List of patient-contacting materials,
3) Pre-clinical studies,
4) Clinical safety report (if applicable), and
5) Risk analysis.
Apart from the changes decried above, the guidance also outlines the document to be submitted in case of changes to the radiation sources, material in an in-vitro diagnostic medical device, labeling, registration information, and other important aspects. In the same way, the guidance describes the documents to be submitted with regard to Category 3 changes which are subject to notification procedure and do not require prior approval of the authority due to the low risk associated thereto.
In summary, the present EFDA guidance describes how the medical device manufacturers and their authorized representatives shall inform the authority about changes made to medical devices that are already placed on the market. In particular, the authority outlines the categories of changes based on the significance of impact they cause on safety, quality, and performance of medical devices and also highlights the main aspects to be considered by the parties involved.
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