Other important temporary regulations

·         Anvisa has defined exceptional regulations for the evaluation of applications for the registry of drugs and biological products for prevention and treatment of the new coronavirus (Covid-19). The rules also establish extraordinary procedures for post-registration changes, when the company makes a change in the original registration of the drug or biological product. In addition, there is an extraordinary change to the registration of products for laboratory (in vitro) diagnosis of the virus. The rules are valid for 180 (one hundred and eighty) days, starting from March 18, 2020. More information: http://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-348-de-17-de-marco-de-2020-248564332  

·         Anvisa published a standard that simplifies the requirements for the manufacture, import and acquisition of medical devices identified as priority for use in health services – extraordinarily and for a limited time. Those are surgical masks, N95, PFF2 or equivalent particulate respirators, goggles, face shields, disposable hospital clothing (waterproof and non-waterproof aprons/coats), caps and bibs, valves, circuits and respiratory connections for use in health services. More information: http://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-356-de-23-de-marco-de-2020-249317437 

·         As of March 20, Inmetro lifted the mandatory certification of surgical gloves and non-surgical procedure gloves made of natural rubber for 12 months, and for the same period, the certification of Personal Protective Equipment (PPE) – semi-filtering facial piece/mask. More information:  https://www4.inmetro.gov.br/noticias/comunicado-luvas-e-epis-mascaras