The new article describes in detail the aspects related to various software products, including the ones intended for remote diagnostics or facilitating administrative procedures.

The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the products regulated as Software as a Medical Device (SaMD). The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or obligations, but rather to assist medical device manufacturers (software developers) in achieving and sustaining compliance with the existing regulatory framework. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect the respective amendments to the underlying regulations. The document is structured as questions and answers – in particular, it contains the most important questions raised by the industry and answers provided by the authority. The questions describe various software products, while in answers the authority outlines the regulatory approach to be followed and provides the reasoning behind it. 


Hearing Loss Self-Test Software 

One of the examples the document contains describes a self-test software available via the website and intended to be used to assess hearing loss. Should the latter be identified, a customer will be directed to an online store. Thus, the product is intended to be used by any customer in order to identify whether it is a hearing loss in place. At the same time, the test conducted is not definitive, and will not provide a final diagnosis report. 

As explained by the authority, such software falls within the scope of regulation 10 of RDC 185/2001 and should be subject to regulation as a Class II medical device. It is also important to mention that a product subject to regulation as a SaMD could be supplied in any form, including being available online via the website. 

Centralization Software 

Another example provided in the guidance describes a centralization software used in order to align the two-eye lenses with the two-eye frame to make sure they are exactly centralized in front of the patient’s two eyes. For this purpose, the software will use high-resolution photographic images of the facial area to be updated on the data server. The software could be provided in the form of an application. 

According to the explanation provided by ANVISA, the software indicated for centralization of lenses that determines the geometric data of the patient’s eye center, analyzing high-resolution photographic images of the facial area and a software intended for production/manufacturing does not fall within the rules described in RDC 185/2001 and, consequently, is not subject to regulation as a medical device under the SaMD framework. 


Laboratory Automation Software 

The industry also raises the question about the laboratory automation software intended to facilitate the processing of information collected in the course of investigation activities conducted in laboratories. In particular, such software is used to process and store data from examinations conducted. 

In accordance with the applicable regulatory requirements, the software for the administration of laboratory data falls outside the scope of the medical device definition due to its functions and features. At the same time, software intended to analyze laboratory data in the course of decision-making (diagnosing) purposes will be considered a medical device and should be subject to regulation based on the risks associated thereto (risk-based classification for medical devices will apply). 


In-House Products 

The existing regulatory framework provides that SaMD products classified as Class I and Class II medical devices are not subject to registration when such products are developed for in-house use. At the same time, nowadays many healthcare institutions partner with start-ups developing innovative healthcare products, including software-based ones. The question raised by the industry in this respect is related to the regulatory status of such products. 

The authority explains that even innovative software products falling within the above mentioned risk categories are not subject to registration when developed for in-house use. In such cases, the responsibility and risk of the use of this product fall on the health service [provider], which is obliged to validate its product by generating documentation that allows [to ensure] tracking and responsibility; given the obligation to use this product to be exclusively internal to the health service [provider], including its affiliates, in this case, the service [provider] will be able to track the use of the software in its patients, allowing corrective actions and eventual responsibilities. 

It is further stated that in-house SaMD could be used only in the patients of the respective healthcare institution (health services provider), while any use for external patients will require prior registration. 


Clinical Decision Support System for Risk Classification 

The scope of the guidance also covers the aspects related to the regulatory status of a Clinical Decision Support System (CDSS) that performs risk classification, tests, and medication suggestions based on medical guidelines and protocols published by the respective institutions. Such a system identifies variables and applies respective protocols. The system will only use pre-defined protocols. 

As explained by ANVISA, a software product intended to conduct risk classification, examination and suggest medications based on guidelines and protocols will be considered SaMD subject to regulation as a Class II or Class III medical device depending on the scope of illnesses and conditions it is intended to address, as well as the treatment it will suggest. 

In summary, the present ANVISA guidance describes in detail the regulatory approach to be applied with respect to certain types of software products depending on their functions, features, and intended use. The scope of the guidance covers the products used for remote diagnosing or administrative purposes. 


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