EMERGO SUMMARY OF KEY POINTS:

• ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches.
• Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.

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.

Additional Brazilian medical device regulatory information from Emergo:

• ANVISA medical device registration and approval consulting
• Brazil GMP (BGMP) quality system compliance support
• Brazil medical device regulatory strategy report
• Whitepaper: Brazil’s medical device registration process
• Video overview: ANVISA medical device approval