The present article describes in detail the decision-making process to be followed when determining the regulatory nature of the changes and further steps to be taken. In particular, the document addresses the aspects related to the changes to the design of a medical device and the sterilization process and methods applied.
The Tanzania Medicines and Medical Devices Authority (TMDA), a county’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the submission of applications for changes to approved medical devices and in vitro diagnostics. The document describes the approach to be followed by medical device manufacturers intended to make changes to their products already placed on the market. In particular, the guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and could be subject to changes, should such changes be reasonably necessary to reflect changes to the underlying legislation. The guidance provides, inter alia, a detailed description of the decision trees – the step-by-step flows explaining the way the regulatory nature of changes in question should be determined.
Decision Tree C – Changes in Design
According to the document, changes in design could include a wide range of changes medical devices could be subject to. Hence, all such changes should be subject to a rigorous evaluation to assess the impact they are expected to cause on the safety and/or effectiveness of a medical device. This includes verification and validation procedures to be performed in strict accordance with the procedures set forth by the quality management system, while the results of such an assessment should be considered when determining the regulatory nature of the changes subject to review. The authority further indicates several important spheres changes which would require special attention.
- Control Mechanism. As explained by the TMDA, almost all changes in the control mechanism of a device raise questions of safety and efficacy; therefore, in most circumstances, these changes require submission of an application for changes.
- Operating Principles. Similar to changes in the control mechanism, changes to the operating principles, including a change in the source of energy used by the device, require an application for change; these changes are often accompanied by significant changes to device labeling.
- Design Specifications. Changes to the design specifications, physical description, patient or user interface, software, or firmware may be significant if they affect the indications for use of the device. When assessing such changes, the manufacturer should duly identify whether the changes to be implemented are expected to affect the indications for use, are clinical data required to ensure the safety and proper performance of a modified device; and whether the new safety- or performance-related questions arise due to the changes.
At the same time, the authority mentions that if the changes in question are only “tightening of design specifications”, while no new features are implemented, they will not be considered significant.
Decision Tree D – Changes to Sterilization
The next decision tree described in the guidance applies to changes related to the sterilization process. In this respect, the authority mentions that the nature of sterilization is such that it is impossible to determine by inspection and testing if the sterilization of the actual device(s) has been successful. Hence, to ensure an acceptable level of sterilization, the entire sterilization process should be subject to assessment and validation. The medical device manufacturer intended to make changes to the sterilization process employed would have to provide all documentation describing the processes and procedures followed and specify the changes that could potentially affect the overall effectiveness of a sterilization process. The changes that would require special attention include, inter alia, the following ones:
- Changes that increase the bioburden alert or action levels or that introduce an organism that is more difficult to kill;
- Device design and material changes that introduce a feature that is more difficult to sterilize;
- Changes in sterilization process or equipment or cycle parameters;
- Changes in the density or configuration of the sterilization load;
- Changes to the quality control verification and validation process such as introducing parametric release.
The authority also mentions that a similar approach should be applied for changes to the device’s packaging in case the device is intended to be supplied sterile. Actually, according to the applicable regulatory requirements, any change to the sterilization method or process of a medical device, or a change to the packaging for the sterilization of a medical device is considered to be a significant change. Thus, medical device manufacturers should pay special attention to any changes impacting the effectiveness of the sterilization process the device undergoes. This also includes the aspects related to compatibility with the packaging material used, as in the case of medical devices intended to be supplied sterile, packaging should ensure the device remains sterile within the whole period of shelf life.
At the same time, in case the changes to the sterilization process or packaging have already been reviewed and approved for a similar medical device, additional approval would not be required. Such an approach is intended to reduce the regulatory burden on medical device manufacturers. However, the authority additionally emphasizes that the said approach could be applied only for devices of identical material and similar design, and only if the proposed changes have been wholly and completely represented and approved in a previous application.
Furthermore, it is also stated that in case the changes to the sterilization process the medical device manufacturer is going to introduce are intended to introduce a more strict control (e.g., adding a new test acceptance criteria or test method), such changes would be considered minor, apart from cases when such change is made from a non-parametric release to a parametric release.
In summary, the present TMDA guidance describes the approach to be applied to changes related to the design of the device, and also the sterilization process and packaging. The document highlights the key points to be considered by medical device manufacturers when determining the regulatory nature of the changes they are going to implement and the regulatory pathway to be followed.
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