The new article provides details regarding the regulatory matters related to the responsibilities of the parties involved, telemedicine, accessories, and languages in the context of software as a medical device.
The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the products subject to regulation as software as a medical device (SaMD). The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers (software developers) to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also mentions that the recommendations provided in the document could be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The document provides information in the form of answers to the most important questions raised by the industry concerning the existing regulatory framework. Some of the questions are related to the determination of the regulatory status of the product in question depending on its functionality, as well as on the risks associated thereto.
Application for Elderly Care: Regulatory Status
In one of the questions, an application described is intended for the care of elderly people and has the following characteristics:
- Provides advisory services to relatives and caregivers with respect to routine care;
- Provides labels and schedule for medications;
- Collects anonymized population information for further data analysis and development of artificial intelligence (AI) for the prediction of grievances.
The app provides information related to daily care.
As explained by the authority, the application with an indication for labels and general information on the daily care of the elderly including medication schedule, that can be used and updated by caregivers or relatives for accompaniment and history does not fall under the rules described in RDC 185/2001 and RDC 657/2022 and does not constitute a medical device that will be subject to regulation under the existing framework.
Role of Health Establishments
The document also describes the role of health establishments in the context of SaMD. Under the general rule, healthcare institutions may use software products, and even participate in their development to the extent agreed with the SaMD manufacturer (developer). In most cases, healthcare institutions are responsible for the correct use of the product under the indications for use and instructions provided by the manufacturer, and also for communicating information about adverse events associated with the products used. At the same time, should a healthcare institution act as a manufacturer, it would also be subject to the responsibilities of a medical device manufacturer as set forth under the existing legislation.
Smartwatch with ECG Functionality
The industry also raised a question regarding the regulatory status of a smartwatch with software that measures blood pressure and electrocardiogram (ECG). As explained by ANVISA, in case such a product only displays the measurement result on its screen, it will be subject to regulation as a Class II medical device following regulation 10 of RDC 185/2001, hence, should comply not only with the general certification requirements for electromechanical products but also with the device-specific requirements for healthcare products.
However, if the software is responsible for dealing with the raw signal of the smartwatch’s sensors and can measure blood pressure or ECG so that they can be displayed on a cloth, the smartwatch will not be a medical device, only the software will be a medical product and this falls under risk class II by regulation 10 of RDC 185/2001. In this case, a smartwatch itself will be considered a generic platform used to run the software subject to regulation as a SaMD.
The authority also mentions that there were no recent changes to the approach applicable when determining the regulatory status of software products, including the ones related to in vitro diagnostic (IVD) applications.
Concerning the language, the authority mentions that applications should use the official Portuguese language as described in the Orthographic Agreement of the Portuguese Language of December 16, 1990.
Another example provided by the industry describes an application intended to improve communication between healthcare professionals and patients. Such an app provides the functionality for continuous and individualized monitoring of a person’s health with the possibility of direct communication. The app is intended to promote a healthy lifestyle, including the reduction of smoking, the performance of physical exercises, and a healthier diet.
According to the explanation provided by ANVISA, applications that have a function only to establish communication between doctor and patient and registration of health data in electronic medical records for subsequent verification by doctors are not considered SaMD under the existing regulatory framework. At the same time, if the software performs a prescription of any medication, such software will be subject to regulation, unless its functionality is limited to merely communicating a prescription from a doctor to a patient (in such a case it would not be subject to regulation).
In case an application in question has therapeutic functions and is intended to be distributed only to doctors, such an application will be considered a medical device and should be regulated accordingly.
In summary, the present Q&A document issued by ANVISA highlights some important aspects related to the determination of the regulatory status of software products depending on their functions and features. The document also describes the approach to be applied concerning the language and technology platforms used.
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