ANVISA – Brazil’s National Health Surveillance Agency – has taken a significant step in strengthening its regulatory framework.
In promulgating RDC No. 153/2017, it is reducing the amount of regulatory red tape in the licensing of companies subject to health surveillance.
The strategic goal of this ANVISA resolution is to rationalize, simplify and harmonize procedures and requirements related to health surveillance licensing. RDC No. 153/2017 brings an interesting legislative approach to the technical regulation of the subject matter by establishing degrees of risk in business development in the life sciences and health sectors in Brazil. This further strengthens standardized procedures for licensing-related safety.