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Brendon Nafziger, DOTmed News Associate Editor | January 01, 2012
From the January 2012 issue of HealthCare Business News magazine
Used dealers need not apply
Although a big market, and one that is “value-conscious” when compared to the U.S. or other developed countries, Brazil is surprisingly off-limits to one class of sellers: used equipment dealers.
In a recent report, the Commerce Department placed Brazil on its list of 16 countries that in some cases have restrictions "so severe as to be tantamount to a prohibition." Thanks to regulation passed in 2001, the RDC 25/2001, in order to be imported into Brazil, used devices must be registered, licensed and refurbished back to original manufacturer specifications, as well as passed through local quality control tests.
"OEMs can bring their products to Brazil easily, such as Phillips, GE, Siemens, since they have a better control on how to refurbish [that] equipment," an official who works with the Commerce Department told DOTmed News earlier this year. "One of the main regulations is that the company that will export to Brazil must have an authorization from the OEM to sell in our country. But even this way, this is still a difficult procedure."
And while Brazil has allowed refurbished equipment to be imported, even that is changing. Carlos Goulart, the head of trade group Abimed, told DOTmed News that Anvisa, Brazil’s equivalent of the Food and Drug Administration, is worried that even refurbished devices aren’t safe. This summer, Anvisa floated a proposal that would completely ban refurbished imports. In acknowledgement of the proposal, the public sent Anvisa almost 1,000 responses, Goulart said. But it seems nothing will sway them. Last week, a manager with Anvisa told Goulart that they would almost certainly go ahead with the proposal, likely to be formally announced this year, he said.
“In the final round, they will tell us what was accepted and what was not accepted, but I’m sure that refurbished equipment from abroad will not be accepted,” Goulart said by phone.
An exception to the rule might be carved out for hospitals. In Brazil, a hospital that wants to sell a piece of equipment to another hospital must first get the equipment refurbished, Goulart said. This could require sending the equipment back to the manufacturer (abroad) to have it fixed up, and then brought back into the country for the sale.
While it’s possible Anvisa might make an exception for these hospitals, American companies that have been importing refurbished equipment will likely have to change their strategies. Goulart said he knows of one U.S. firm that could be especially hurt by this. The company brings in used equipment to Brazil, refurbishes it there, and then ships it out to be sold in foreign markets.
“We asked (Anvisa) to allow this, because they are creating jobs in Brazil. They are fostering the knowledge of manufacturing,” he said. “We don’t know if they will accept (this kind of) importation.”
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