Brazilian legislators have stepped in to limit substantial increases for quality management system inspection fees in a boon for ANVISA medical device registrants.

The country’s Ministry of Finance had pushed through massive fee spikes for Brazilian Good Manufacturing Practice (BGMP) certification that are now in effect, but lawmakers have now issued a new law, Law 13202/15 (link in Portuguese) limiting increases to 50% of prior fee amounts. Legislators found no legal basis for the finance ministry’s staggering price hikes, and Brazilian president Dilma Rousseff agreed.

BGMP, registration fees adjusted downward

As Emergo reported in September 2015, BGMP certification fees for foreign firms had been boosted from R$37,000 (about USD$9800/€8860) to R$108,612 (about USD$28,900/€26,000), while ANVISA registration fees for devices and IVDs were more than doubled. These increases had the potential to price smaller foreign device manufacturers out of the Brazilian market.

The new law is expected to limit BGMP fee increases to no more than R$55,000 (about USD$14,700/€13,200); ANVISA registration fee increases will also be adjusted downward. The Ministry of Finance must first update Ordinance 701/2015 to reflect the new law before the lower fee increases go into effect.

Reimbursements to be made available

In some cases, once Ordinance 701/2015 revisions are complete, companies that have already paid higher BGMP and/or registration fees may request reimbursements for the difference between the initial higher fees they paid and the revised increases set by Law 13202/15. However, reimbursements will only be available from December 9, when the new law was published; firms that paid higher fees between September 9 and December 8 will not be eligible for refunds.

Emergo’s office in Brasilia is monitoring these developments, and will provide further updates on ANVISA registration and BGMP fees when they become available.