Health products play a crucial role in modern society, directly contributing to the well-being and quality of life of individuals. These products range from medical devices to dietary supplements and over-the-counter medications, providing a wide array of therapeutic and preventive benefits. The significance of these products lies in their ability to treat illnesses, alleviate symptoms, and promote health, enabling people to lead healthier and more productive lives. However, due to their direct influence on public health, it is imperative that these products be rigorously regulated. Regulation ensures the effectiveness, safety, and quality of the products, safeguarding consumers from potential risks and ensuring that the benefits outweigh any potential harm.
Among medical devices, we have products for in vitro diagnostics, equipment, instruments, and also software as a medical device. According to RDC No. 751/2022, Software as a Medical Device (SaMD) is considered a medical device that performs its functions without being part of the hardware of a medical device, having the following specificities:
- SaMD can run on a general-purpose computational platform (non-medical purpose);
- The “computational platform” includes hardware and software resources (operating system, processing hardware, storage, database, display devices, programming language, etc.);
- “Without being part of” means that the program does not need the hardware of a medical device to achieve its intended purpose;
- Software is not considered SaMD if its purpose is to control the hardware of a medical device;
- SaMD can be used in combination with other products, including other medical devices;
- SaMD can interact with other medical devices, including hardware from other medical devices and other SaMD, as well as general-purpose software; and
- Mobile applications (apps) that meet the definition are considered SaMD;
Just like medical devices in general, SaMD needs to undergo a risk classification to determine the type of documentation that must be submitted for registration with ANVISA – ensuring its commercialization. The classification follows RDC No. 751/2022, and depending on the intended use of the device, the risk classification can vary between Class I, II, III, and IV.
Regarding the regularization of SaMD, RDC No. 657/2022 is used as a reference, and it outlines the requirements for labeling and instructions for use, as well as the requirements for assembling technical dossiers – according to the associated risk class.
In the case of Class III and IV SaMDs, the technical dossier must include a declaration of conformity with international standards or their national versions. Among these requirements, the declaration must contain at least the following versions:
- IEC 62304:2006 – Medical device software — Software life cycle processes;
- IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices; e
- ISO 14971:2007 Medical devices — Application of risk management to medical devices.
On October 19, 2022, ANVISA also provided a file with the main questions and answers regarding RDC 657/2022, which can be accessed at this link: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/software-como-dispositivo-medico-perguntas-e-respostas
