Premarket and postmarket regulatory challenges for mechanical ventilators: scenario in Brazil and comparison with other countries

Abstract

BackgroundThis study critically assesses the regulatory challenges faced in Brazil for mechanical ventilators amid the COVID-19 pandemic. It evaluates the effectiveness of expedited regulatory actions, compares strategies with other countries, and proposes future optimization in emergency conditions. Methods: Premarket submissions of mechanical ventilators were surveyed, involving accompanying certification documentation, rejections, approvals, and cancellations. Postmarket occurrences were surveyed until June 2023, evaluating their incidence and presence of certifications. Regulatory pathways in other countries were reviewed for comparison. Results: Brazil’s regulatory strategy increased its ventilator supply capacity 17 times in 10 months. However, the absence of essential certifications in 95.52% of the premarket submissions, such as the Certificate of Conformity issued by the Brazilian Conformity Assessment System (CC-SBAC), raised safety and performance concerns. Among temporarily approved ventilators, the main cause of cancellation (76.92%) was the absence of certifications after the temporal approval, notwithstanding the already installed devices maintaining authorization for use in health services. Postmarket alerts lacked CC-SBAC issuance in 75% of the cases when sponsors reported the occurrences. It highlighted the importance of ongoing technical assistance and monitoring, particularly for devices lacking proper certifications. Conclusions: The extraordinary regulatory conditions in Brazil significantly impacted ventilator premarket evaluation. However, lacking essential certifications led to post-approval cancellations. Postmarket occurrences emphasized necessary vigilance, with most alerts involving uncertified devices. Improved premarket evaluation, considering component shortages and real-world usage scenarios, as collaborative efforts from other countries and international bodies, is crucial for ensuring the safety and effectiveness of ventilators in public health emergencies.