The new article addresses the aspects related to the post-approval stage, such as the validity of the certificates or changes thereto.
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 marketing authorization for medical devices. The document provides additional clarifications and recommendations to be considered by manufacturers and other parties interested in placing medical devices on the country’s market. The document is non-binding, so in case of any discrepancies with the provisions of the underlying legislation, the latter should prevail.
Validity and Renewal
First of all, the document describes the aspects related to the validity of marketing authorization certificates, as well as the renewal thereof. Under the general rule, marketing authorization is valid for five years. Hence, upon expiration of the said period, the appropriate certificate should be subject to renewal for the authorization holder to be allowed to offer its products in Ethiopia. According to the requirements, a renewal application could be submitted when it remains less than three months before the expiration date, while the authority encourages the authorization holder to apply for renewal at least two months before the validity period will expire since the renewal process takes some time. An application dossier for renewal of a medical device authorization should include, inter alia, the following elements:
- Cover letter or Application letter;
- Valid and genuine Quality Management System Conformance Certificate from accredited and recognized Conformity Assessment Body;
- Valid, original, and genuine Free sale Certificate or Marketing Authorization Certificate from relevant and Competent National Regulatory Authority;
- Valid, original, and genuine Manufacturing License;
- Declaration of Conformity;
- Valid, original, and genuine Good Manufacturing Practice Certificate (if applicable);
- Letter of Confirmation of No Change OR Summary of Changes after its recent approval by EFDA;
- Device Vigilance and Post-market Surveillance Reports (for devices that are sterile, have measuring functions, and all class III/C and above).
The authority also mentions that in case the authorization holder will apply for renewal after the expiration of the initial certificate, the registration of the product should be conducted from the very beginning, and all the appropriate procedures are to be followed.
Correction and Appeal
According to the guidance, a certificate holder may apply for correction to be made to the recently issued marketing authorization certificate, provided such an appeal has been submitted no later than 1 month from the date the certificate has been issued, while all requests submitted upon expiration of the said term would not be accepted by the authority. Apart from this, an applicant may follow the appropriate complaint handling procedure to file a complaint regarding the decision taken by the authority about the application for marketing authorization.
The scope of the guidance also covers the aspects related to changes to medical devices implemented after the marketing authorization has been granted, and also the way such changes should be reflected in the respective certificate. Under the general rule, such changes should be subject to review from the safety and effectiveness perspective, as it is important to assess the way and extent the changes will impact the operations of the device. According to the Article 21(1) of the Food and Medicines Administration Proclamation (No. 1112/2019), if variation affecting the registered medical device’s safety, quality, or effectiveness is introduced, the product may not be marketed unless the person who registers the product notifies such variation and get approval from the Authority. Thus, the authorization holder should provide the authority with accurate and comprehensive information about the changes to be implemented for the latter to be able to assess the impact such changes would have on the safety and effectiveness of the product. In particular, the authority will assess the information provided to ensure the party responsible for the device has duly analyzed the impact of changes. Furthermore, it is stated that for any anticipated change to a medical device, a manufacturer must consider the impact of the change on the patient, practitioner, and/or user of the medical device, and the impact of the change on the specifications of the medical device, and device whether the changes are expected to impact the safety and performance of the medical device. It is also important to mention that there is separate guidance on post-approval change notification issued by the authority, where additional clarifications and recommendations are provided. The said guidance describes the way the changes should be treated, including such aspects as categorization of changes and actions to be taken concerning changes based on such categorization. The authority encourages authorization holders to follow the recommendations provided in the said guidance to ensure compliance with the applicable regulatory requirements and streamline the procedures associated thereto.
The applicable legislation also provides an option for the authorization holder to apply for a withdrawal of a marketing authorization certificate – for instance, in case the product is no longer available on the market. In such cases, a party responsible for a medical device in question should duly notify the authority about the actions taken concerning the product, while the withdrawal request should be accompanied by the appropriate justification. The authority additionally emphasizes that if the aforementioned actions are related to the issues with the device itself (e.g., it’s quality), this should be clearly stated in the withdrawal request.
In summary, the present EFDA guidelines outline the main aspects to be considered by medical device manufacturers when applying for marketing authorization for their products, as well as after such authorization has been granted. The document describes in detail the responsibilities of marketing authorization holders, provides additional clarifications regarding the applicable regulatory requirements they should follow, and also highlights specific matters requiring additional attention. By the virtue of the guidance, the authority explains the way provisions of the underlying legislation should be interpreted and followed, and also indicates the steps to be taken in various situations that can occur.
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