The new article described in detail the aspects related to the evidence required for software products based on novel technologies, as well as to the determination of the regulatory status of the products depending on their functions and features. 

The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory requirements for software as a medical device (SaMD). The document is intended to provide additional clarifications for the existing regulatory requirements, as well as non-binding recommendations to be considered by medical device manufacturers (software developers) to ensure compliance thereto. It is important to mention that the authority reserves the right to make changes to the present guidance document and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. 

The document contains the most important questions raised by the industry representatives to the existing regulatory framework, and also the answers provided by the authority. The scope of the document covers the main issues medical device manufacturers (software manufacturers) face. 


Applicability of the Requirements 

In question number 7, the industry representatives are asking about the regulatory status of software that is intended to assist users of contraceptive medication which is itself registered with ANVISA by providing the details of particular pills to be taken and the proper sequence. As additionally mentioned by the industry representatives, the product in question does not trace any additional information, nor present any additional information beyond the scope of documentation accompanying the medication. The product also has an alarm function reminding about the medication to be taken. 

The authority explains that even if the product described is not intended to encourage and maintain well-being and healthy activities, it still does not meet the definition of Software as a Medical Device since it is not intended for prevention, diagnosis, treatment, rehabilitation or contraception (even though it is used to control the administration of contraception, having the schedule and alarm functions). Thus, according to the applicable legislation, such a product is not considered a medical device, so the respective regulatory requirements would not be applicable.

Validation Requirements 

Question number 8 refers to the requirements for validation for software products that are not considered innovative, nor employ innovative technology. Industry representatives are raising the question of whether clinical or analytical validation will be required for such a product. Furthermore, additional clarification is requested regarding the approach to be applied when determining whether the product should be considered innovative. 

As it is stated by the ANVISA, the clinical or analytical validation must include the dossier or technical report of any software as a medical device, even if it does not possess innovative technology, the purpose of use, or way of functioning; these validations or verifications are related to a specific product that must prove that it works according to the standards established in the market and do not necessarily need to undertake a clinical analysis to verify safety and efficacy, which is only required for innovative products. 

The authority further explained that when determining whether the technology used, the purpose of the use or the way of functioning of the software is considered innovative, a responsible party should take into consideration other products already placed on the market. Under the general rule, a new technology, the purpose of use, or the way of functioning is considered innovative in case it is not used for a while sufficient to collect evidence demonstrating its safety and effectiveness. The authority mentions that depending on the technology and intensity of its use, such a period could range from 5 to 20 years from the moment the first product was launched. However, medical device manufacturers (software developers) are encouraged to contact the authority in case of any doubts regarding the regulatory status of their products. 


Using Videoconferencing for Diagnosing Purposes 

Question number 9 describes a situation when a mobile application is used to diagnose a patient and suggest a treatment. Industry representatives are requesting additional clarifications regarding the regulatory status of such products. 

In response, the authority states that telemedicine software that performs only the functions of medical records, agenda, the transmission of data and communication, whether by video, audio or text, do not fall under the rules described in RDC 185/2001 and RDC 657/2022 and do not constitute medical devices regularized by Management of Equipment Technology. The authority further explains that the product in question will not be considered a medical device since the diagnosing and suggesting a treatment are provided via the software but are not its functions, i.e., not performed by the software itself. 


Software for the Development of Individualised Exercise Series 

In question number 10, industry representatives are asking for additional clarification regarding the regulatory status of software intended to develop individualized exercise series for each user based on user-specific indications without a medical diagnosis. The question from the industry is whether such a product could be considered well-being software exempted from regulation under the framework of the medical device. 

The authority explains that such a product would be considered a Class II medical device since the individualized exercise series the device develops are considered to be treatment. At the same time, in case such a product will offer only access to a database of exercises, while a healthcare professional will choose the particular ones to be applied, a product would not be considered a medical device.

In summary, the present ANVISA guidance highlights certain specific aspects related to the determination of the regulatory status of software products depending on their functions and intended use. The document also describes the approach to be applied when determining the scope of evidence to be provided depending on the nature of the device and technologies used. 



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