The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, continues to receive feedback from the industry representatives regarding the proposed changes to the rules and regulations on post-approval changes of medical devices. The appropriate draft guidance is available on the authority’s official website and is open for public consultation. The EFDA intends to improve the existing change control regulatory framework by considering the suggestion submitted by the medical device manufacturers and other parties involved in operations with medical devices.
General Approach to Medical Device Change Control
The EFDA recognizes the importance of the changes to be made to the medical device during its life-cycle in order to improve its safety or effectiveness. At the same time, due to the significant impact that such changes could cause to the patients` health, the authority states that all substantial changes to EFDA-approved medical devices should be subject to additional assessment. In order to ensure the amended device meets any and all applicable safety and performance requirements, additional assessments will be performed by the authority themselves. Changes suggested by the medical device manufacturer in question do not result in increased risk associated with the use of the device by healthcare professionals or patients (users) themselves. In the course of such an assessment, the EFDA would evaluate the evidence demonstrating compliance with the appropriate requirements to make a reasonable decision regarding approving or disallowing such changes due to the safety concerns.
As it is explicitly stated in the present EFDA guidance, when planning a change to a medical device, the manufacturer shall consider the effect such a change would have on the patient`s health. All changes should be properly evaluated from the risk/benefit balance standpoint.
In particular, the EFDA guidance on change control is intended to provide the medical device manufacturer with the additional information regarding the categories, types of changes, and the particular principles such division should be based on. In addition, they also provide information regarding the actions medical device manufacturers should commit in order to make changes to the EFDA-approved device already marketed in Ethiopia.
The scope of the guidance covers change control for all medical devices properly approved by the authority to be marketed in Ethiopia. In terms of the reason for the variation, the document covers both changes requested by the EFDA and implemented by the manufacturer itself on its own discretion. At the same time, the guidance should not be applied in case the device in question is still to be evaluated and approved by the regulating authority.
Ethiopian Medical Devices` Regulations: Key Terms
The document provides definitions for the most important terms related to medical devices and changes thereto including, inter alia, the following ones:
Change – a variation made to the EFDA-approved device (e.g. changes to materials and components, manufacturing methods, labeling, or information supplied with the device).
Cautions and precautions – special notices informing the user of the device about the aspects requiring additional attention to ensure the use of the device in a safe and efficient manner. The scope of these terms covers actions to be performed by the users in order to avoid causing harm to health as well as the details regarding the potential adverse effects arising when using the device.
Indications for use – particular situations or conditions the device is intended to be used in. The indications for use should be defined by the manufacturer of the device and properly indicated in the labeling, instructions for use, and other informational materials supplied with the device according to the applicable Ethiopian medical device regulations.
Recall – a special action to be performed by the entity responsible for placing the device on the market in case if the device could cause a hazard to the patients` health, fails to comply with the safety and performance information provided by the manufacturer or fails to comply with the requirements set forth by the legislation on medical devices.
General Principles of Change Control for Medical Devices
The draft EFDA guidance on change control describes in detail the principles to be applied in order to divide all changes into the appropriate categories. The categories depend on the risk associated with the use of the device in question, its safety, and performance features. As it was already mentioned before, when considering the device could be marketed after the changes being made, the EFDA would evaluate the evidence demonstrating compliance with the applicable safety and performance requirements in order to assess the risk/benefit balance.
According to the guidance, all changes to the EFDA-approved medical devices are failing within the following categories:
- Category 1 changes – ones resulting in significant changes to safety, performance, or quality of the device. In this case, the device should be subject to the new registration.
- Category 2 changes – ones requiring prior approval to be granted by the authority due to the moderate impact on the safety and performance of the medical device.
- Category 3 changes – ones resulting in minor impact and thus allowed to be implemented immediately without prior approval of the regulating authority. It is also important to mention that the medical device manufacturer shall confirm the category assignment by filing the appropriate request to the authority. If the manufacturer of the device fails to determine the category or the authority finds such determination as incorrect, the EFDA is entitled to make a final determination and to assign the proposed changes to the proper category. The correct determination would impact the future process and procedures related to making changes to the EFDA-approved medical device.
Change Categories in Detail
In order to assist medical device manufacturers in making a correct determination for the changes, the EFDA guidance provides a detailed description of the changes falling within the scope of each particular category.
According to the guidance, the category 1 changes cover, inter alia, the following ones:
- Changes to the intended purpose of the device indicated by the manufacturer, or its indications for use (except the cases when such changes constitute a reduction of indications for use providing it is not related to safety or effectiveness issues).
- Changes to the class of the device under the risk-based classification.
- Changes to the software impacting other features and characteristics of the medical device.
- Changes falling outside the scope of the medical devices grouping rules,
- Changes to the medicinal substances (in case of combination devices).
- Listing of the new devices with other proprietary names.
The EFDA guidance on changes to medical devices also contains a table describing the documents and information to be provided when making Category 2 changes to the device duly approved by the authority and placed on the Ethiopian medical devices market depending on the scope of the particular changes in question.
Summarizing the information provided hereabove, the present change control guidance covers the most important aspects related to the procedure of making changes to the EFDA-approved medical devices for the manufacturer to be allowed to market its devices in Ethiopia.
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