Update on Medical Device Registration Fees

In 2015, the Ministry of Finance attempted to implement a considerable increase in registration and quality inspection fees for medical device regulators.

Brazilian medical device market regulators plan to officially reduce those fees.

A technical note, Ordinance 45/2017, was sent to the new government regulation where ANVISA clarifies that these rates should not exceed 50% of the country’s inflation index.

On February 9, Ordinance 701/2015 will be revoked and Ordinance 45/2017 will come into force, establishing higher rates for registrations and inspections of Good Manufacturing Practices (BGMP).

However, those who have already paid ANVISA the new fees after February 8, 2015, may request partial reimbursement on a date to be decided by the regulatory agency.