But over a series of meetings last year, Abimed was able to show that the fears were "exaggerated" and that refurbishing equipment was important, in that it can expand patient access to devices that could be out of reach of the budgets of some hospitals.

Still, Goulart said the group recognizes the need for regulations. Abimed wants to encourage a system where the rules would allow importing refurbished equipment that met certain classifications, such as whether similar equipment was manufactured in Brazil.


"Those ones which are not manufactured here, for example, an MRI, probably there are clients that cannot afford a brand new one, but they can buy one refurbished," Goulart said.

The group also advocates for Anvisa to include rules for good manufacturing practices, similar to what is advocated by COCIR, a European medical technology lobby. In fact, for a meeting last year, Abimed brought a COCIR representative to Brazil to meet Anvisa regulators.

But Goulart said they still haven't scheduled the next formal discussion with Anvisa, and there's a lot of work left to do. For instance, the regulatory agency also wants device-importing rules to include aggressive waste disposal guidelines required by Brazil's strong new waste management law.

"I would say it could get harder," Goulart said.

Brazil medical device market, by the numbers

(Estimated 2010)

Total market size: $4.38 billion
Imports: $2.88 billion
Imports from the U.S.: $860 million
Market growth in 2010: 10 percent

Source: U.S. Department of Commerce

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