NEW RULES FOR SOFTWARE AS A MEDICAL DEVICE APPROVED BY ANVISA
The Brazilian Health Regulatory Agency (ANVISA) agency with a mandate to promote the protection of the population’s health by executing sanitary control of the production (including facilities, processes and raw materials), marketing and use of products and services subject to health regulation, published on the Union’s Official Gazette, of March 24th, 2022, RDC 657/2022 approved by its Collegiate Board which addresses the regularization of software as medical devices (the so called “SaMD”).
This new regulatory framework enters into effect on July 1st, 2022 and is the result of the Public Consultation 1.035/2021, ended in June 2021, which received more than 400 contributions.
Before the new regulatory framework, ANVISA applied to this matter RDC 185/2001, which governed medical devices in general. The text of the former Resolution had a content primarily focusses on physical products (tangibles), not digital ones (intangibles), thus, under a paradigm different from the deep ongoing digitization process in health, far from current standards.
In order to create a favorable background for the creation of the new rules, ANVISA prepared a Regulatory Impact Analysis Report comprising the specificities of software as a medical device, emphasizing the increasing growth in the use of technology in the healthcare sector and also the growth and constant advances in this area.
The new RDC 657/2022 is consistent with practices from other international health authorities, such as in the European Union and United States, placing Brazil in a position to achieve stronger cooperation agreements with such health authorities.
The first section of the new regulation clarifies which types of software the rule does not apply to, inter alia:
– software used for well-being: those projected to encourage and maintain the well-being including healthy activities as physical exercises, health control and monitoring and a healthy lifestyle that are not intended for diagnosis, treatment, or rehabilitation;
– listed in a list of non-regulated products, as published by ANVISA;
– used exclusively for administrative and financial management in health services;
– that processes demographic and epidemiological medical data, without any clinical diagnostic or therapeutic purposes;
– embarked in a medical device already regulated by ANVISA.
The second section is dedicated to important definitions of terms associated to SaMD.
The requisites on use and labeling comprised by RDC 185/2001 and RDC 431/2020 remain in force, with the new norm encompassing a Chapter with the inclusion of several relevant information as i) alerts and warnings; ii) minimum hardware and software requirements; and iii) cybersecurity information.
The expected outcome is that the new regulatory framework will help to simplify classification and registration of those types of medical devices, offering greater legal stability, strengthening the use of such mechanisms and fostering innovation by software developers.
