Brazilian Medical Device Registration and BGMP Fees Spike
The Brazilian Ministry of Finance has pushed through substantial fee increases for medical device registration and quality management system certification that went into effect September 9, 2015.
According to an Emergo analysis, the fee increases (link in Portuguese) may need to be implemented via resolution RDC 222/2006. In the meantime, ANVISA has published the Ministry of Finance's proposed fees to its website, which means the new fees should be considered now in effect.
The increases will more heavily impact foreign manufacturers than those based in Brazil or neighboring countries. It is worth noting that these increased fees are being pushed through by the Brazilian government in lieu of tax increases on the general population, which has proved politically untenable.
Specifically, Brazilian Good Manufacturing (BGMP) certification fees will increase from R$37,000 (about USD$9800/€8860)* to R$108,612 (USD$28,900/€26000)*. GMP fees for Mercosur countries (including local manufacturers and firms based in other South American countries) will increase less substantially, from R$15,000 to R$38,000.
ANVISA registration fees for medical devices and IVDs have also increased by 2.5 times their current rates, as well.
A new ANVISA technical note (link in Portuguese) on the increases explains that registrants that will have paid any relevant fees under the current schedule before September 9 2015 but whose applications are submitted after that deadline will have to pay the difference. Failure to pay will result in ANVISA returning—but not rejecting—an application.
Further details are expected once ANVISA publishes updates to RDC 222/2006; Emergo will provide further details as we learn them.
*Exchange rate as of September 3, 2015