Brazil’s Agência Nacional de Vigilância Sanitária is facing criticism from the medical device industry for hiking surveillance inspection fees as the country faces tough economic times.
ANVISA maintains the fee increase — the first in the regulator’s 16-year history — is not a tax, but a restoration of purchasing power established by the nation’s legislature that had depreciated over time, but device groups disagree.
Brazilian industry group ABIMO says devicemakers are making strides and developing innovative, cost-effective products, despite the adverse economic environment, and is examining legal action.
Under the new fee scheme, a good manufacturing practices certificate for companies in Brazil or Southern Common Market member countries will jump from about U.S. $3,900 to more than $11,000 for the biggest firms. Foreign manufacturers face an even greater increase — from $9,684 to more than $28,000 — irrespective of size. The new fees took effect Sept. 9. Manufacturers that didn’t meet the Sept. 8 deadline to pay the old fees must pay the difference.
A document on the ANVISA website details the fees, breaking them down for microenterprises, small companies, medium and large companies.
Roberto Rodrigues, an attorney at Licks Legal, says the fees affect a range of regulated industries and could bring in as much as $350 million.
A technical note explaining the fees is available here: www.fdanews.com/091515-anvisa.pdf. The document breaking down the fees is available at www.fdanews.com/091515-ANVISA-fees.pdf. — Elizabeth Hollis, Jonathon Shacat.