The new article provides a detailed overview of the regulatory requirements related to documentation to be submitted by an entity interested in placing its medical device on the market.
The Ethiopian Food and Drug Authority (EFDA), the country’s regulatory agency in the sphere of medical devices and other healthcare products, has published guidelines dedicated to the marketing authorization of medical devices. The scope of the document covers, inter alia, the aspects related to medical device conformity assessment. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. However, provisions of the guidance are non-binding, so in case of any discrepancies with the respective provisions of the applicable legislation, the latter should prevail.
Under the general rule, any medical devices intended to be marketed and used in the country should comply with the Essential Principles of Safety and Performance, while medical device manufacturers should duly demonstrate this by providing supporting documentation addressing the aspects related to the design, development, and manufacturing processes. These documents should be accompanied with detailed enough descriptions and clarifications justifying the approach applied by the manufacturer. Moreover, a party responsible for a medical device should update the respective documentation to ensure its accuracy about the current status and specifications of the product. Thus, a medical device manufacturer is obliged to submit for review the documentation demonstrating compliance with the said essential principles, as well as any other requirements the device in question could be subject to. The evidence contained therein should reflect the current status of the device subject to review and be provided in the form prescribed by the respective regulatory requirements. The authority also mentions that the level of regulatory scrutiny, and the extent of evidence necessary would depend on the risks associated with a medical device and the technologies it is based on. All the information submitted by the manufacturer to the authority should be complete and accurate, that should be confirmed by a responsible person signing the documents on behalf of the manufacturer applying for marketing authorization. The authority will review the documentation provided and assess whether the evidence submitted is in line with the applicable regulatory requirements. It is also important to mention that the requirements applied by the Ethiopian authority concerning the technical documentation are based on the IMDRF’s Submission Table of Contents for Marketing Authorization of Medical devices and IVD medical devices. Currently, there are two different pathways for general and in vitro diagnostic medical devices respectively.
Declaration of Conformity
According to the guidance, a medical device manufacturer may confirm compliance with the applicable regulatory requirements by issuing a “Declaration of Conformity”, a written document whereby it is stated that the medical device intended to be placed on the market is fully compliant with the respective requirements, and all necessary documents are in place. It is important to mention that such a declaration should be updated by the manufacturer once it is necessary to reflect the changes to the product.
The authority mentions that concerning the approach to be applied for declarations of conformity, the manufacturers should also refer to other guidance documents issued by the EFDA.
Registration of the Parties Involved
Apart from the aspects related to the documentation accompanying the submission for marketing authorization, the scope of the guidance also covers the regulatory matters related to the registration of manufacturers and/or license holders, local representatives, as well as the devices themselves.
As set forth by the applicable legislation, all the entities involved in operations with medical devices should be duly registered and licensed by the respective regulatory agencies to be allowed to conduct such activities, while any medical devices intended to be placed on the Ethiopian market should be registered as well.
As further explained by the EFDA, the said registration constitutes the basic level of regulatory control. The authority takes all the steps to ensure it has sufficient information about all the parties involved in operations with medical devices allowed for marketing and use in the country. According to the guidance, before placing a medical device on the market, the manufacturer, distributor, importer, wholesaler, and authorized representative should provide EFDA with adequate information concerning facility licensing and medical device registration requirements. All these aspects are addressed in the respective guidance documents issued by the authority.
To assist medical device manufacturers and other parties involved in operations with medical devices with interpreting and following the applicable regulatory requirements, the present guidance provides a summary table highlighting the most important aspects to be considered. In particular, the table provides information about the scope of conformity assessment for different classes of medical devices under the risk-based classification. The document describes conformity assessment elements, responsibilities of medical device manufacturers, and also conformity assessment requirements corresponding to each of the aspects including, inter alia, the following ones:
- Conformity assessment of the quality should include the assessment of a quality management system to be developed and implemented by the manufacturer by the international standard ISO 13485.
- The management system to be assessed includes post-market surveillance as the set of measures to be taken by medical device manufacturers to ensure the continuous safety of the products placed on the market. These measures include the ones related to the investigation and reporting of adverse events and incidents associated with medical devices, handling complaints, and also field safety and corrective actions to be taken in case of serious issues identified. In this regard, the authority will review respective plans and policies to be developed by the parties involved in operations with medical devices.
As it was mentioned before, the level of regulatory scrutiny would depend on the class of the device in question under the country’s risk-based classification. This will also determine the extent to which the manufacturer should collect information related to the products it is responsible for and provide it to the authority.
In summary, the present EFDA guidance provides an overview of the regulatory requirements related to the documentation accompanying medical devices. The guidelines also outline the most important aspects associated with conformity assessment.
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