The new article describes in detail the aspects related to the products intended to process medical records, as well as the ones based on the use of non-medical hardware platforms (smartphones).
The Brazilian regulating authority in the sphere of healthcare products (ANVISA), has published a guidance document dedicated to products subject to regulation as Software as a Medical Device (SaMD). The document provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance thereto. In particular, the guidance is structured as a questions-and-answers document and includes the most important questions raised by the industry representatives, as well as the answers and explanations provided by the authority. It is also important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Furthermore, the authority reserves the right to make changes to recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Medical Recommendations System
One of the examples provided in the guidance describes a system intended to optimize recommendations using medical records (including the data deriving from medical consultations) and compilation of information regarding the applicable good practices. At the same time, it is explicitly stated that the recommendations provided by such a system would neither be used for medical consultations, nor impact the decisions taken by healthcare professionals, but would only serve as an additional source of information to be considered. The system will use standard protocols used in similar cases, and other information available. However, the industry representative raising this question mentions that the system is not intended to suggest complex solutions.
According to the explanation provided by the authority, the system described hereabove will be subject to regulation as a Class II medical device and, consequently, will be subject to registration under the notification procedure. As further explained by ANVISA, all the software products that provide recommendations to healthcare professionals with respect to the actions to be taken, even if such recommendations are based on existing records, should be subject to regulation as medical devices. In this particular case, the authority recommends the party involved in the development process get in touch with the authority with additional details regarding the system, its functionality, and features, in order to discuss the applicable regulatory requirements before applying for marketing approval.
Protocol Access System
Another example provided in the guidance describes a system that is also intended to operate medical data, however, in this case, the system provides healthcare professionals with access to the protocols they’ve used before. It is explicitly stated that the system will have no impact on the process of creating the protocols, as they will be created by healthcare professionals themselves with no involvement in the system.
With respect to such a system, the authority states that if it will be used for automating the process of creating protocols and thus could potentially impact the protocols created, it could fall within the scope of a medical device definition and be subject to regulation accordingly. At the same time, if the functionality of the system is limited to merely accessing the protocols and facilitating operations with them, while healthcare professionals are still making independent decisions, such a system would not be subject to registration as a medical device.
The document also describes a situation when there is an electronic game developed to be used by children with certain dysfunctions in order to help them to exercise with more fun. For example, such software could exist in a form of an electronic game (application) to be downloaded on a smartphone. When used, this game will encourage children to do physical therapy exercises based on body movement.
As explained by the authority, the classification of this type of software (software for entertainment that can be used in treatments) as a SaMD will depend on the claims made by the manufacturer, since it is not a product with functions typically associated with the medical area. A software for entertainment, such as games or recreational activities, will be SaMD if the manufacturer indicates (in advertising materials or instructions for use) that the product is intended for treatment. Should it be the case, such a product will be subject to regulation under the medical devices framework in order to be allowed for marketing and use in the country.
Digital Image Processing Software
The guidance also provides clarifications related to the regulatory status of the products based on Digital Image Processing technology. In particular, one of the examples provided in the document describes a software intended to analyze urine strips using such said technology. The image shall be captured using a mobile phone’s camera. The industry representative raising this question explicitly states that the strips the software is intended to analyze are the ones duly registered according to the applicable regulatory requirements.
With respect to the above product, the authority states that the intended use described falls within the Class II medical device concept and should be subject to registration under the notification procedure. The ANVISA additionally emphasizes that the manufacturer must also pay special attention to the validation of the compatibility of the software with the various types of cameras available, defining which minimum configuration is compatible and verifying this compatibility through validation. Furthermore, it is also stated that the authority intends to verify the safety and effectiveness of such products by the virtue of an additional assessment to be conducted.
In summary, the present ANVISA guidance describes in detail the regulatory approach to be applied with respect to certain software-based products, some of which should be subject to regulation as medical devices (SaMD). The document also highlights the key points the attention should be paid to.
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