Feb 16, 2018
EMERGO SUMMARY OF KEY POINTS:
Brazil’s medical device market regulator ANVISA has updated regulations laying out federal, state and local-level oversight responsibilities for sanitary surveillance activities.
Under RDC 215/2018 (link in Portuguese), the roles of federal, state-level and local ANVISA branches in the Brazilian medical device regulatory process are mapped out and clarified; this regulatory organizational chart is important for ANVISA registrants to know which regulatory officials to deal with at various levels of the Brazilian oversight structure.
The new RDC keeps existing ANVISA oversight structures in place. Activities including device registration, product control and Brazilian Good Manufacturing Practice (BGMP) inspection and certification remain the purview of ANVISA’s federal-level agency.
ANVISA offices will begin complying with RDC 215/2018 in May 2018; the final compliance deadline is January 5, 2019.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: