Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products

15 Mar 2019

• By Bernard Murphy

Brazil has passed legislation enabling class I (lowest risk) devices and diagnostics to gain market approval through a notification pathway rather than under the current review-based registration system. The move is essentially intended to help regulatory agency Anvisa refocus its efforts toward the higher-risk arena.

Brazil's notification pathway regime, which comes into effect on May 2, 2019, is enshrined in Resolution RDC 270 of Feb. 28, 2019, through amendments to RDCs 36 and 40 of Aug. 26, 2015. These regulate, respectively, in vitro diagnostics and medical devices, across both classes I (low risk to individual patients and low risk to the public) and II (medium risk to individual patients and low risk to the public). RDC 270 affects home-produced and imported products, but does not apply to products made for exportation.

RDC 270/2019 features two main sections. The first, under the Chapter 2 heading, covers essentially the amendments to the registration...