Aiming to keep up with the scientific and technological advances and meet new demands from the health care sector, ANVISA published – on the 30^th of March 2022 – RDC 657/2022 which provides for the regularization of Software as a Medical Device (SaMD). The Resolution will come into force on the 1^st of July 2022.

According to the Agency, traditional regulations for medical devices present a gap, as they do not cover specific aspects for this type of products. Among ANVISA’s goals were the development of a regulatory model on the virtual and disruptive context of medical softwares, international alignment and cybersecurity regulation in connected devices.

The Resolution published by ANVISA defines SaMD as “software that meets the definition of a medical device, whether in vitro diagnostic (IVD) or not, being intended for one or more medical indications, and which performs these purposes without being part of a medical device”. Also included in the definition are mobile applications and software with in vitro purposes, if their indications are included in the general definition of medical devices, as well as software licensed by subscription and centrally hosted (Software as a Service), provided that it falls within the scope of medical devices’ definition.

The Resolution does not apply to:

* Software for well-being, intended to encourage and maintain well-being or control health and healthy lifestyle, without carrying out prevention, diagnosis, treatment, rehabilitation or contraception activities;

* Software listed as non-regulated products (in a list made available by ANVISA);

* Software used exclusively for administrative and financial management in health services;

* Software that processes demographic and epidemiological medical data, without any clinical diagnostic or therapeutic purposes;

* Software embedded in a medical device under sanitary surveillance.

For regularization purposes, SaMDs (including those for in vitro diagnostic use) must be classified according to the rules and classes presented in RDC 185/2001, or subsequent regulations.

In case of software’s distributed online, the label information and instructions for use can be made available in the software itself, in order to be exempt from physical presentations. In addition to the information required under current regulations for medical devices, instructions for use of SaMDs must include procedures for updating the SaMD; minimum hardware and software requirements; operating principle, including generic descriptions of algorithms, routines and formulas used to generate clinical processing; alerts and warnings; interoperability specifications, indication of software compatibilities and incompatibilities, hardware and technological environment; and cybersecurity information.

SaMDs’ regularization follows the general provisions for the regularization of medical devices. However, additional requirements related to the particularity of these devices must be included in the Technical Dossier – to be kept in the possession of the holding company, for class I and II SaMDs; or presented at the time of product registration, for Class III and IV SaMDs. Among these documents, the declaration of compliance with international standards or their national versions stands out, including:

I – IEC 62304:2006 – Medical device software — Software life cycle processes;

II – IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices; e

III – ISO 14971:2007 Medical devices — Application of risk management to medical devices.

Other requirements can be checked in articles 11 and 12 of the Resolution.

SaMDs’ alterations must follow the general provisions contained in RDC 340/2020. Additionally, alterations that (I) create new functionalities or clinical indications of use; (II) significantly affect clinical functionality, clinical safety and efficacy, or performance associated with the foregoing purposes; and (III) mischaracterize the visual identity, so that the software is no longer recognizable in the images sent to ANVISA – must have an alteration petition filed with ANVISA.

The Resolution also addresses SaMD’s proof of safety and efficacy. It should be noted that the regularization processes granted prior to the effectiveness of this Resolution must be adequate or complemented when filing future alterations.

Despite the new Regulation, there were no changes regarding the rules for classifying SaMDs, which follow general rules for classifying medical devices according to RDC 185/2001. The legislation that will replace and update RDC 185/2001 is expected to be published this year, and will bring specific classification rules for SaMDs.

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DOMO Salute Team