The article describes in detail the application process to be followed concerning changes to legally marketed medical devices.
The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the submission of applications for changes to medical devices (both general and in vitro diagnostic ones) approved for marketing and use in the country. The document provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the recommendations provided therein, should it be necessary to reflect the corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the application process to be followed when submitting an application related to changes to a medical device already placed on the market.
As explained by the TMDA, once the medical device manufacturer has determined the regulatory status of the changes in question, a change application should be submitted following the respective requirements. It is also important to mention that for the submission the changes could be grouped as described in the guidance, hence, a single application could address multiple changes, provided the grouping criteria are met.
First of all, the document describes the existing application types and highlights the key points to be considered by medical device manufacturers when preparing and submitting such applications. In this respect, the authority emphasizes the following aspects:
- As it was mentioned before, several changes could be covered by the scope of a single application. In such a case, the application will be subject to rules applicable to the highest category (if the categories of changes covered by the application are different).
- In case the identical changes are to be implemented for multiple medical devices already placed on the market, such changes could be combined into a single application as well, provided that the changes are identical, otherwise the application will be rejected. Hence, in case of non-identical changes, separate applications will be required.
- In certain cases, the changes related to medical devices of different classes under the applicable risk-based classification could be covered by the scope of a single application. Such an approach could be applied in case of (a) change in product applicant/market authorization holder; (b) change in the manufacture and/or sterilization site; (c) change only involves an update of QMS certificate validity date; or (d) addition of identical Class A accessories.
Changes Related to Recalls
The authority also describes the approach to be applied for changes related to a recall – a special action taken in case of serious issues associated with the device, giving rise to a need in removing medical devices from the market. As explained by the TMDA, changes occurring as a result of a recall are to be assessed to determine if they are significant, including design changes or design specification changes required to bring a medical device back in line with previous performance specifications. It is further stated that cover letters accompanying device applications in response to a recall should identify that the application for change is being submitted for this purpose.
The authority also encourages medical device manufacturers to get in touch in advance, before applying, if the latter is related to a recall, to discuss specific aspects associated thereto. The TMDA also mentions that the situation in which the changes are to be implemented would also be considered when determining the application review timeline, as sometimes this is related to certain safety concerns.
According to the main decision tree, it is the very first question of the assessment – whether the changes subject to review are related to a recall. If yes, the manufacturer would have to assess the changes in detail to determine whether they should be considered significant. Non-significant changes would be subject to a notification procedure implemented to reduce the regulatory burden medical device manufacturers are subject to. The questions of the next steps are used to determine the particular decision tree to be applied when assessing the changes further and deciding on a specific regulatory pathway to be followed when submitting an application associated with such changes.
The document also outlines additional rules and requirements to be considered by medical device manufacturers when applying changes to a medical device already placed on the market. The main considerations include, inter alia, the following ones:
- Applicants can submit one application for change into the same medical device that is part of multiple device registrations (as part of a Family, System, Group, Test Kit); the product selected for implementation for the proposed changes must be the same in the registered family, system, group, or test kit.
- The list of situations when changes related to medical devices registered in different classes could be included in a single application is exhaustive. In all other cases, separate applications are to be submitted.
In summary, the present TMDA guidance provides an overview of the regulatory requirements related to the applications for changes to medical devices already placed on the market. The document highlights the key points to be considered for various changes and describes the way the applicable approach should be determined depending on the nature of the changes and risks associated thereto. The guidance also describes the decision trees intended to assist medical device manufacturers and other parties involved in choosing the proper regulatory pathway to be followed.
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