The National Health Surveillance Agency (“ANVISA”) published yesterday in the Official Gazette the Resolution RDC No. 657/2022, which provides for the regularization of software as medical device (SaMD). The topic is part of ANVISA’s 2021-2023 Regulatory Agenda and has been discussed together with society in recent years, especially from the opening of Public Consultations no. 730/2019 and no. 1,035/2021.
The RDC No. 657/2022, which provides for the regularization of software as a medical device (SaMD), will come into force on July 1st, 2022.
In order to keep up with scientific and technological advances in the regulated sector and meet the new needs and demands of health care sector, the Resolution published by ANVISA defines SaMD as “software that meets the definition of medical device, which may be in vitro diagnostic (IVD) or not, intended for one or more medical indications, and that accomplishes these purposes without being part of medical device hardware”.
Are also included in the definition of SaMD (i) mobile applications and software with in vitro purposes, if their indications are included in the definition of medical devices; and (ii) software licensed on a subscription basis and centrally hosted (Software as a Service), provided that it can be defined as a medical device.
Nonetheless, the Resolution does not apply to software (i) for well-being, intended to encourage and maintain well-being or health control and lifestyle, without performing prevention, diagnosis, treatment, rehabilitation or contraception activities; (ii) classified as a non-regulated product by ANVISA; (iii) used exclusively for administrative and financial management in health services; (iv) that processes medical demographic and epidemiological data, without any clinical, diagnostic or therapeutic purpose; and (v) embedded in medical devices under sanitary surveillance.
In addition to RDC No. 657/2022, the following apply to SaMD (i) the same rules and classes of RDC No. 185/2001; (ii) the same provisions of RDC No. 185/2001 regarding instructions for use and labeling, also adding the specific technological information for software provided in article 7 of RDC No. 657/2022; (iii) the provisions of RDC 340/2020 for changes in information, being necessary to notify ANVISA about the creation of new functionalities or indications for use, significant changes in clinical, safety, efficacy and performance features, and changes on visual identity in such a way that it is no longer possible to recognize the software when compared to the images sent to ANVISA; (iv) the provisions of RDC 546/2021 concerning the regularization of SaMDs, complemented by the information indicated in art. 17 of Resolution no. 657/2022, specific for software.
If there is any doubt in the classification resulting from the application of the sanitary framing rules contained, the company may request the framing through the communication channels of ANVISA’s site.
According to art. 5 of the RDC, the registration of SaMD developed internally (in house) by the health service and for exclusive health use, which fall into risk classes I and II, do not require the issuance of marketing authorization, provided that they do not interfere with devices that require regularization. Nonetheless, they cannot be commercialized or donated without being regularized and must have their validation records stored for at least 10 years, under penalty of sanitary and administrative penalties. The deadline for in house validation of SaMD by health services is 2 years from the publication of the resolution.
Regarding SaMD menus, the Resolution establishes that they should preferably be in Portuguese, and may alternatively be in English or Spanish, provided that the instructions for use explain, in Portuguese, the meaning of each menu item and commands, the software is not intended for use by laymen or in the home environment, and that the instructions for use inform the need for a level of fluency in the language as a prerequisite for operators.
The Resolution also requires a declaration of compliance with international standards or, alternatively, the presentation of technical justification and documents demonstrating the safety and efficacy of the product, being forbidden to sell or make available to new users with expired or cancelled regularization.
Finally, it was also established that the maintenance of product compliance is the responsibility of the company, and the post-market monitoring of SaMD behavior, as well as the notification of adverse events, technical complaint, and field action should be communicated to ANVISA, based on the current legislation. Our public and regulatory law team is at your disposal to clarify any doubts regarding the novelties introduced by the referred Resolution.