The article provides an overview of the regulatory requirements related to changes to medical devices already placed on the market.
Table of Contents
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 submission of applications for change(s) to approved medical devices and in-vitro diagnostics. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers intended to introduce changes to their products. The present document which constitutes the initial version of the guidance has been published by the authority in June 2022.
The guidelines are intended to assist medical device manufacturers in submitting the applications related to the changes they are going to make to the products they are responsible for. In particular, the document describes specific steps to be taken by medical device manufacturers to ensure compliance with the requirements set forth by the existing legislation.
It is also important to mention that the present guidance and recommendations provided therein are non-binding. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective regulations and has been agreed with the authority in advance. The authority also reserves the right to request additional information, beyond the scope outlined in the present guidance, should it be reasonably necessary to assess the safety and effectiveness of medical devices subject to changes.
As further explained by the TMDA, changes on approved medical devices have been categorized based on the risk upon their implementation from significant changes that include Major, Minor, Notifiable and impermissible changes. The “Major” classification applies in case the level of risk related to the change is high, so the authority will need additional time to conduct a rigorous assessment, while the manufacturer would have to provide detailed enough information about the changes in question and the way they are expected to impact the safety and effectiveness of the device. Minor changes are the ones associated with low risk, while notifiable changes do not cause any impact on the safety or performance of the device. The concept of “impermissible” changes (original guidance refers to “unpermitted” and “un permissible” stands for significant changes that may lead to change in the design, performance, and intended use of the medical device thus resulting in the submission of a new application (the manufacturer would have to apply for marketing approval as it is a new medical device).
To assist medical device manufacturers in interpreting the provisions of the applicable legislation, as well as recommendations provided herein, the authority also provides the definitions of the most important terms and concepts used including, inter alia, the following ones:
- Active Medical Device – any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.
- Active Device Intended for Diagnosis – any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring, or support in treating physiological conditions, states of health, illnesses, or congenital deformities.
- Medical Device Accessories – separate, finished devices intended to support, supplement, and/or augment the performance of at least one parent device.
- Medical Device Family – a group of medical devices that are made by the same manufacturer that differs only in shape, color, flavor, or size, that have the same design and manufacturing process, and that have the same intended use.
- Medical Device Procedure Pack – a medical devices group placed on the market to be used for a specific single medical procedure.
Regulatory Approach: Key Points
Under the general rule, a party placing a medical device on the market should be responsible for ensuring its safety and proper performance when used for its intended purpose throughout the whole service life. At the same time, the authority is responsible for developing and implementing the appropriate procedures for ensuring the safety, quality, and effectiveness of any medical devices intended to be marketed and used in the country. For this purpose, the authority conducts the initial assessment and grants permission necessary to place a new product on the market. As is also mentioned by the authority, the manufacturer should implement efficient measures in terms of post-market surveillance, and also continuously assess the development of technologies and make modifications and improvements to the device.
The present document provides additional clarifications regarding the regulatory requirements to be considered when submitting an application related to the changes to medical devices. The scope of the guidance covers both general and in vitro diagnostic medical devices. As it is stated by the TMDA, the document provides a three-phased assessment tool that includes: general information in identifying a significant change; type of changes; a series of decision trees to aid in decision making; and a list of change examples.
According to the guidance, the existing regulatory requirements for changes to medical devices are based on the guidelines and principles developed by the WHO, as well as other national regulating authorities, such as Health Canada or the Health Sciences Authority (HSA) of Singapore.
The authority additionally emphasizes that in the case of several changes implemented to the device at once, each of the changes should be assessed separately to identify and evaluate the impact it would have on the safety and effectiveness of the device. In certain cases, it will be necessary to provide additional evidence confirming the statements and claims made by the manufacturer concerning a modified device.
In summary, the present TMDA guidance provides an overview of the regulatory requirements related to applications for changes to medical devices already placed on the market. The document highlights the key points to be considered by medical device manufacturers to ensure compliance with the respective rules and regulations.
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