The role of civil society in the innovation and incorporation of medical devices in Brazil

Abstract

Objective: To address the normative context regarding the processes of social participation in the phases of Research, Development and Innovation (RD&I), sanitary regulation and assessment for incorporation of technologies into SUS. Methods: Descriptive exploratory research with review of normative references and document analysis: i) in the regulatory milestones of Brazilian Innovation; ii) sanitary regulation by the National Health Surveillance Agency (Anvisa); and iii) in the assessment and incorporation of medical devices in the National Committee for Health Technology Incorporation into SUS (Conitec). Results: In the websites of government institutions that support RD&I linked to the MCTI, mechanisms of social participation established in the legislation were observed. In the regulatory context, social participation is inserted since the construction of regulations until key stages of the technology lifecycle. In the assessment of medical devices, we verified an expansion of engagement strategies, such as the “patient perspective” in the plenary meeting. From its 64 public calls, five were directed to medical devices. Conclusion: The importance of social participation in the stages of the life cycle of medical devices was evidenced, in view of the specificities of these technologies. Anvisa and Conitec has expanded participation mechanisms, in addition to those established by law. In the RD&I stages, initiatives are incipient, with actions being located according to legal provisions. The expansion of effective participation mechanisms favors the construction of effective solutions to minimize health challenges and to promote greater transparency, value for society and confidence in Brazilian health decisions.