The new article highlights the most important aspects related to conformity assessment of medical devices intended to be marketed and used in Ethiopia. In particular, the present article provides an overview of the conformity assessment in general and also outlines the main points related to quality management systems and post-market surveillance.
The Ethiopian Food and Drug Administration (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published guidelines dedicated to medical devices marketing authorization. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. However, provisions of the guidance are non-binding in their legal nature nor intended to introduce new rules or requirements the parties involved should follow.
Conformity Assessment: Key Points
First of all, the authority mentions that it is responsible for ensuring any medical devices allowed for marketing and use in the country meet the applicable safety and performance requirements within the whole life cycle of such products. The activities to be taken in this respect include, inter alia, conformity assessment performed before the device is placed on the market, and also post-market surveillance conducted to ensure continuous safety of medical devices supplied to customers. The purpose of conformity assessment is to collect sufficient evidence demonstrating compliance with the applicable requirements. The authority also mentions that a medical device manufacturer should be responsible for conformity assessment concerning the products it is going to place on the market. At the same time, such an assessment should be conducted strictly in line with the provisions of respective legislation and under the supervision of the regulating authority. It is further explained that the extent to which the authority should be involved in conformity assessment depends on the risks associated with the device in question – the higher the risk, the more strict requirements should be applied.
According to the guidance, conformity assessment includes such elements as:
- A quality management system (QMS);
- A system for post-market surveillance;
- Technical documentation;
- A declaration of conformity;
- The registration of manufacturers and their medical devices by the authority.
The guidelines published by the EFDA further describe each of these elements in detail.
Quality Management System (QMS)
Under the general rule, it is the sole responsibility of a medical device manufacturer to develop, implement and maintain a quality management system that ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the EFDA’s regulatory requirements. The particular aspects to be covered by the said QMS should be determined depending on the medical devices in question, their complexity, technologies used, as well as the risks associated thereto and other factors. The authority additionally emphasizes that in case a medical device manufacturer decides to outsource some of the processes, it remains responsible for their outcomes and thus should ensure efficient control over them.
As it was mentioned before, the extent to which EFDA will be involved in conformity assessment would depend on the risks associated with the product subject to review, consequently, will be determined based on the class of the device in question under the applicable risk-based classification. In this regard, the guidance highlights the following approach to be applied:
- Manufacturers of Class I devices and Class A IVD devices shall implement and maintain the basic elements of a QMS but have the option to exclude design and development controls; the QMS for manufacturers of Class I & II devices and Class A & B IVD devices are normally not subjected to premarket on-site audit by EFDA. The authority also mentions that its involvement would still take place in the case of sterile medical devices or the ones with measuring functions. Moreover, the authority reserves the right to conduct audits of the said facilities whenever it finds it reasonably necessary to ensure the safety of the products.
- Manufacturers of Class III & IV devices, and Class C & D IVD devices should implement and maintain an effective QMS that includes design and development controls and should comply with the Authority’s current Good Manufacturing Practices of Medical Devices. To ensure compliance with the said requirements, the authority will take the appropriate measures including the review of documentation and reports, as well as on-site audits. Upon successful completion of such audits, the authority will issue the appropriate certificates outlining the list of products the inspected quality management system covers. The validity of these certificates will be limited in time.
Post-Market Surveillance: Scope of Responsibility
Apart from establishing the proper manufacturing processes, medical device manufacturers should develop and implement the procedures to be followed to ensure continuous compliance with the applicable regulatory requirements after the products are supplied to customers. The aspects to be considered in this respect include the procedures of handling complaints, adverse event reporting, as well as the actions to be taken in response to safety issues identified. The authority states that medical device manufacturers should develop respective plans for all the products they are responsible for. When developing such plans, the manufacturer should consider the nature of the device in question, and also the risks associated thereto. As a part of post-market activities, manufacturers shall establish the processes of ongoing collection and analysis of safety- and performance-related data, and also take actions based on the information collected. Should the need for corrective actions be identified in the course of a said data collection, such actions should be taken without undue delay, and the authority should be informed accordingly. The manufacturers are also obliged to notify the EFDA about serious safety-related adverse events that occurred, as well as about the measures taken to ensure the safety of products already supplied to customers. All the activities should be performed by the post-market surveillance plan to be developed by the manufacturer. Such a plan should be included in the scope of documentation to be submitted to the EFDA when applying for marketing authorization.
The document also describes the reporting requirements set forth under the existing regulatory framework. As prescribed by the applicable legislation, medical device manufacturers should prepare a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. Such a report should include all relevant information and be provided to the authority on demand. It is important to mention that in the case of high-risk medical devices (Class III & IV), such reports should be submitted when applying for renewal of the marketing authorization.
In summary, the present EFDA guidance outlines the most important aspects to be considered by medical device manufacturers concerning the quality management system and components thereof. The document also describes the main responsibilities of medical device manufacturers related to post-market activities.
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