EMERGO SUMMARY OF KEY POINTS:

• Brazilian regulators have officially revoked medical device registration and quality system inspection fee increases pushed through in late 2015.
• Under Ordinance 45/2017, ANVISA registrants that paid higher fees will soon be eligible to file for partial refunds.
• Registrants that avoided higher fees via an ABIMED lawsuit will not qualify for refund requests, however.

Brazilian medical device market regulators plan to officially reduce registration and quality inspection fees for medical device companies after the country’s Ministry of Finance attempted to push through a hefty increase of those fees in 2015.

A technical note from ANVISA regarding the Brazilian government’s new Ordinance 45/2017 explains that the regulator will limit fee increases to 50% of the country’s inflation index; the ordinance takes effect February 9, 2017, and revokes Ordinance 701/2015 that established higher fees for registration and Brazilian Good Manufacturing Practice (BGMP) inspections.

ANVISA registrants that paid increased fees on or after December 9, 2015 will be eligible to file partial refund requests at a later date to be announced by the regulator. However, firms that leveraged a 2016 lawsuit by Brazilian trade group ABIMED to avoid paying higher fees will not be eligible to file for refunds.

For more information on Brazil’s medical device registration and quality system compliance requirements, watch our video overview and read our BGMP whitepaper.