Software used as medical devices and various medical equipment with software are not certifiable. Brazil does not have a regulated software certification process as a medical device, mainly due to the absence of an ABNT, IEC or ISO standard that allows its certification.
However, there is a voluntary and private certification experience of the Brazilian Society of Health Informatics (SBIS) in partnership with the Federal Council of Medicine (CFM) for Electronic Health Registration Systems (SBIS). This type of software, despite belonging to the health area, does not automatically characterize the need for regularization in Anvisa, according to Technical Note No. 04/2012/GQUIP/GGTPS/ANVISA.
Nevertheless, the above-mentioned regulations bring in their scope the software as a medical device (with the designation of software), some built-in requirements are impossible to be met by the software and other requirements subject to interpretation, which weakens its application. These requirements were designed for tangible (physical) goods. However, the software, unusual at the time, is intangible (virtual). Thus, it is not conceived, for example, a software bringing indelible label or even labelling or printed manuals for software distributed over the Internet or by mobile applications or batch and series control, when it should have control by versioning.
Other information essential for software, such as forms of updating, is not part of the sanitary requirement.
There were also requests from the regulated sector and company with participation in the Internal Consultation and sector dialogues during the construction of the regulatory agenda 2017-2020, and its consequent inclusion in it.
Another motivator is that the software has been the leader in recalls for 13 consecutive quarters at the FDA through the first quarter of 2020. As the distribution of the software is global and virtual (e.g., Android and Apple app stores, Internet, etc.), it can infer that Brazil is suffering the same consequences. The following ranking positions refer to problems of labelling, quality and sterility.
In addition, the software as a medical device had discussions within the of the International Medical Device Regulators Forum (IMDRF), of which Brazil is part and harmonizes its regulations, resulting the creation of 5 guiding documents to the countries that are members of the forum to build their regulations.
Therefore, it would be necessary to update the regulation.
Finally, it was verified the need to adapt the regulation to the current health scenario, aiming, above all, to meet the new needs and demands of health care, modernization in regulation and scientific and technological advances in the sector.
Thus, the objectives of this theme related to anvisa's strategy are:
• Expand the safe access of the population to products and services subject to Health Surveillance;
• Improve the regulatory framework in Health Surveillance;
• Optimise premarket actions based on risk assessment sanitary care;
• Improve regulatory cooperation and convergence actions within the international scenario.