A decade of improvement of health legislation for medical devices and its impacts on the health regulation cycle

Abstract

Introduction: The sanitary regulation of medical devices was improved with a focus on sanitary risk, through the  simplification of regulatory steps and the reduction of the administrative burden. Objective: To evaluate the impacts of the improvement of health legislation during the decade 2012-2021 by three indicators representing government, company, and product. Method: The indicators developed to evaluate the health regulation cycle are 1) Anvisa’s regulatory performance (by median evaluation time of medical devices); 2) companies’ performance in complying with health legislation (by proportion of medical devices not authorized for sale); and 3) evidence of medical device health risk (due to adverse events, technical complaints, health alerts and preventive/cautionary measures). Influence analyses were carried out with variables associated with regulatory process, company size and medical device characteristics as predictors of the indicators. Results: The first indicator shows that the Agency’s timing has improved across all risk classes of medical devices. In 2012, the indicator was measured in 73 days (interquartile range 56–111), while in 2021 in 9 days (interquartile range 6–15). The second indicator showed improvement only for medical devices in the low/medium risk classes. The third indicator did not show an increase in health risk for medical devices with the regulatory simplifications adopted in the last decade. The influence analysis indicates that the need for a certificate of good manufacturing practices, company size and need for additional information are the most relevant predictor variables. Conclusions: The regulatory results from the legislation on medical devices in the last decade were positive.