COVID-19: Brazil adapts its regulatory environment in reaction to the virus outbreak

The Brazilian government has announced a set of measures to adjust its regulatory framework to the context of the Coronavirus (COVID-19). These are part of a series of strategic actions adopted by the Brazilian government aiming to enable rapid and large-volume access to products that can be used to cope with the coronavirus pandemic.

The Brazilian National Institute of Metrology, Standardization and Industrial Quality (INMETRO) and the Brazilian Health Regulatory Agency (ANVISA) have sent five notifications to the WTO informing about the adaptation of its national regulatory framework in an intent to combat the current coronavirus crisis. Additionally, ANVISA has issued further orientation about the priority given on the analysis of Certificate of Good Manufacturing Practices (CBPF) processes and on the preferential access to products needed for in vitro diagnosis of the coronavirus. In addition, INMETRO has also made significant regulatory changes regarding medical devices. These changes include:

• Suspension of mandatory certification for certain health products (i.e. gloves and masks);
• Extension of the validity of verification certificates which expires in 2020 until further notice has increased;
• Suspension of verification of pre-packaged products and measuring devices until further notice;
• Establishment of exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products;
• Medical equipment for personal protection, pulmonary ventilator and other medical devices will not, during one year, need certification from the Brazilian Conformity Assessment System (SBAC) body;
• The manufacturer may present international certification (ISO 13485 or Medical Device Single Audit Program - MDSAP) instead of Brazilian certification (aforementioned CBPF) in order to commercialize its products.

These are part of a series of strategic actions adopted by the Brazilian government aiming to enable rapid and large-volume access to products that can be used to cope with the coronavirus pandemic.