According to ANVISA’s recent announcement, the new clinical data requirements apply to qualifying devices submitted for review in both cadastro and registro registration routes. The key points from the technical notefor manufacturers are:

Clinical data is now required for all novel devices. Some high-risk devices for which ANVISA determines safety and effectiveness may only be demonstrated via clinical investigation also must meet these clinical data requirements; examples of such high-risk devices include drug eluting stents and interspinal devices. Such clinical data must be obtained from pivotal studies for the specific device under review. Studies must have been conducted according to Good Clinical Practice (GCP), and sponsors must supply all pertinent validation data to ANVISA.