Simplification of regulatory practices for approving personal protective equipment and medical devices during the early stages of COVID-19 pandemic in Brazil

ABSTRACT

Purpose: With the exponential spread of the COVID-19 pandemic worldwide, regulatory authorities are taking measures to avoid shortages of medical devices, particularly personal protective equipment (PPE) and medical equipment. The Brazilian Health Regulatory Agency (ANVISA), specifically the Medical Devices General Office (GGTPS), has been reviewing regulatory guidelines and procedures and simplifying approvals for medical devices. Methods: Using public records, we present the Brazilian health regulatory scenario during the first four months of the pandemic (between December 31, 2019, and April 30, 2020). Results: The ANVISA-GGTPS has been making efforts to increase the availability of medical devices for use by healthcare professionals and patients. It has simplified the rigorous regulatory system, as rising COVID-19 cases lead to a shortage of the availability of them. Conclusion: The challenges to overcome shortages raises a pertinent question about how governments, with their respective regulatory authorities, productive supply chains, and Industry 4.0 components, will guarantee the availability of medical goods and maintain the fast flow of the goods in a flexible way, while meeting the standards of quality, safety, and effectiveness. © 2021, Sociedade Brasileira de Engenharia Biomedica.