EMERGO SUMMARY OF KEY POINTS:

• Brazilian regulators have introduced new clinical requirements for all novel medical device registrations as well as for some other high-risk device types.
• For such devices, clinical data must have been obtained from appropriate pivotal studies.

Brazil’s medical device market regulator ANVISA now requires clinical data for all novel medical device registrations as well as for some high-risk devices for which clinical investigations are deemed necessary.

According to ANVISA’s technical note (link in Portuguese), the new clinical data requirements apply to qualifying devices submitted for review in both cadastro and registro registration routes. The technical note’s key components for 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 interspinous 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.

Emergo consultants in Brasilia will track progress of these new clinical data requirements and provide additional implementation and enforcement information as it becomes available.

To learn more about Brazilian medical device registration requirements, download our regulatory process chart and watch our video overview.