Lawsuit in Brazil allows some manufacturers to pay reduced ANVISA fees sooner

By Stewart Eisenhart, Emergo Group

Following a successful legal case against the Brazilian government, some medical device manufacturers may now pay reduced registration and quality system inspection fees without having to request refunds from the country’s Ministry of Finance.

Members of ABIMED, a Brazilian trade group that brought the lawsuit, can now avoid the potentially lengthy process of having to pay higher registration and certification fees and then requesting refunds from the government. Emergo is an ABIMED member, and learned from the group of the successful lawsuit.

Some background

In September 2015, the Brazilian Ministry of Finance pushed through significant fee increases for medical device registrations and Brazilian Good Manufacturing Practice (BGMP) certifications under Ordinance 701/2015; that move was later countered by Brazil’s Congress, which scaled back but did not rescind ANVISA fee increases.

Although fee increases were reduced, the Ministry of Finance must still revise Ordinance 701/2015 to reflect those reductions. Until that revision occurs, ANVISA medical device registrants and BGMP applicants must first pay the original increased fees set by the Ministry; only when Ordinance 701/2015 is revised can registrants apply for partial refunds.

The ABIMED route

Now that the ABIMED lawsuit has succeeded, group members including device manufacturers and Brazilian Registration Holders (BRH) may now pay fee increases adjusted by Congress up front, without having to request partial refunds once Ordinance 701/2015 is updated.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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