The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment.
The Brazilian regulating authority in the sphere of healthcare products (ANVISA), has published a guidance document dedicated to regulatory requirements for Software as a Medical Device (SaMD). The guidance structured as a questions-and-answers document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken by medical device manufacturers and other parties involved in order to ensure compliance thereto. In particular, the document contains the questions raised by the industry with respect to the most important aspects and concerns regarding SaMD regulations, answered by the authority. The latter is using real-world examples described by the industry representatives in order to explain and demonstrate how the respective provisions of the existing legislation should be applied. At the same time, it is important to mention that the present guidance document and recommendations provided therein are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. 


Software and Touch-Sensitive Pods

One of the examples provided in the guidance describes an application software intended to be used with touch-sensitive pods (being accessories thereto) as an intelligent flash reflex training system that involves touching sensitive capsules during the training. According to the claims made by the manufacturer, the said system could be used to learn in a variety of cores and provide visual prompts for training and exercises that can help to improve coordination, reaction time, balance, strength, and other aspects. The touch-sensitive pods are to be connected via Bluetooth, while the application itself will offer various activities for individuals and groups, including exercises at home and/or with a partner, as well as group competitions. The question is whether the product described should be subject to regulation under the SaMD framework provided it allows its users to create personalized exercises.  With respect to the system described hereinabove, the authority states that since the information provided does not reveal any specific indication of use related to medical, dental, or laboratory applications for prevention, diagnosis, treatment, rehabilitation, or contraception, it will not be subject to regulation as a medical device.  Thus, it does not meet the rules set forth by RDC 185/2001 and does not require registration. 


SaMD for Internal Use

Another example provided in the guidance describes in-house software developed to be used by the same healthcare institution or its affiliated companies. Under the general rule, in-house SaMD products are exempted from registration. The question is whether the said exclusion applies with respect to the products intended to be used by patients directly.  In this respect, the authority explains that in order for the said exemption to be applicable, the product in question should be provided for use only to the patients of the same healthcare institution being a developer of the software, while any external supply would require a proper registration in accordance with the applicable regulatory requirements the product is subject to based on its class under the current the existing risk-based classification system. Thus, in-house developed SaMD products could be used only by patients to whom the respective institution provides health services. 

Software for Patient Risk Classification Algorithm

According to the guidance, software intended to be used for patient risk classification could be subject to regulation as a SaMD. As explained by ANVISA, the respective determination should be made based on the way the results of such a classification are intended to be used. Other aspects to be taken into consideration include, inter alia, specific health conditions the software is intended to deal with, as well as the nature of risks classified by the software (e.g., whether they are immediate or not). Furthermore, the initial configuration of the software and the way it could be additionally configured should be also taken into consideration. In such cases, the authority encourages the responsible parties to get in touch in advance to discuss matters related to the applicable regulatory requirements. 

Software for Diagnostic-Related Purposes 

Some of the questions raised and described in the guidance are related to the software products intended to be used for diagnostic purposes.  First of all, the authority states that software products with an indication of use for treatment assistance, such as blocking user actions from a diagnosis, fall within the scope of a SaMD concept and, consequently, should be subject to regulation as a medical device. The same approach applies to software for diagnostic medicine, especially if the software automatically performs diagnosis. At the same time, software intended to interact with the Laboratory Information System will be considered a medical device only when such software has diagnostic functions or is able to control the laboratory equipment. The software intended to issue reports (merely a text-editing function) will not require registration under the SaMD framework. At the same time, should such software have any functions intended to assist in diagnosing or treating, it will meet the definition of a medical device and should be regulated accordingly.  In summary, the present guidance document issued by ANVISA highlights certain specific aspects related to the regulatory requirements for SaMD products. The document explains the way the regulatory status of software products should be applied, and also outlines the key points to be taken into consideration in order to ensure the proper determination of the applicable regulatory framework. 



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