Regulatory Scenario of Brazilian Medical Products for COVID-19

After 8 months of the pandemic, there was an impact on Brazil’s regulatory landscape for medical products supporting and treating OVID-19. It is already possible to make an analysis about the obstacles and the rules of exemption of ANVISA for the entry of Medical Products in Brazil.

The speed of ANVISA’s process analysis and prioritization were crucial to the rapid supply of medical devices to the Brazilian market, identified as a priority for use in health services, due to the international public health emergency related to SARS-CoV-2.

In an agile manner, ANVISA broke barriers and obstacles facilitating the issuance of automatic import authorizations via Siscomex, in addition to the import of products classified as notified without proper regularization by ANVISA. Products requiring Good Manufacturing Practice Certification (CBPF) and registration, had their average analysis time reduced from 1 and a half year to 72 hours. Products such as masks, gloves and respirators entered the country with great speed, in addition to having been verified a growth of the internal market directed to the national production of these products.

In order to make the analysis process transparent to all manufacturers and importers, ANVISA has created a BI – Bussines Inteligence tool which demonstrates in real time all registration requests and CBPF for VOCID tests, where it is possible to follow requests, status, deferrals, requirements and failures.

We are sure that many products of inferior quality or even without proof of effectiveness have entered Brazil in this emergency situation, but ANVISA has fulfilled an important role of acceleration, debureaucratisation and efficiency. It is now redoubling its monitoring efforts in the post market action. There are 148 precautionary measures taken so far, divided among the categories of cosmetics, health products (related), in vitro diagnostic products and disinfectants, such as: interdictions, suspension of imports, distribution, use and collection of products on the market.

Other legislation also contributed to this transit of international products and the rapid supply of the country, and the Brazilian industry itself surprised, because when the pandemic of the new coronavirus led the country to live in a state of calamity, an impact that was feared was that of shortages, whether on supermarket shelves or in the health system. Although the health and economic effects of covid-19 remain, the industry has done its part to help Brazil through this most acute period of crisis that we face. Throughout the country, the productive sector has shown solidarity and speed of response, making rapid adjustments in production lines to meet the basic needs of the population.

Finally, it is important to clarify that this flexibilization does not apply to all products and will not remain active for a long time either. The regulatory window for these adjuvant products in the treatment and diagnosis of Covid-19 should close as soon as the vaccines begin to be marketed, bringing countries out of their state of emergency and back to a new health normality.