Brazil has tough regulations that strictly control the import of refurbished medical equipment. But they could get tougher.

In an informal meeting on Monday, a group of device importers will share proposals with its members on ways to protect and reform the process in the face of efforts last year by Anvisa, Brazil's version of the Food and Drug Administration, to change it or scrap it altogether. Representatives from Anvisa will also be present to listen and share their own ideas.

"They wanted to forbid everything," Carlos Goulart, president of Abimed, a Brazilian trade lobby for medical equipment importers, told DOTmed News.

Brazil has the biggest medical device market in South America -- estimated to be worth nearly $4 billion in 2010. And U.S. exports account for nearly one-third of the country's import sales, according to estimates made by the U.S. Department of Commerce.

But Brazil is entirely off-limits to companies exporting used medical equipment. For dealers of refurbished equipment, exports are legal, but still subject to strict regulations.

In its most 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 pass 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. "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."

The restrictions have led to a thriving black market, according to sources.

"The Brazilian government has an extremely restrictive legislation that forces the market toward...smuggling," an industry source wrote to DOTmed News.

Goulart said the Brazilian government is motivated in part by protectionist concerns to support local manufacturers.

But last year, when Anvisa contemplated forbidding all refurbished imports, the agency's main fear was that Brazil would become a dumping ground for defective used products. "They said all old equipment that the First World does not know what to do with, they'll send to our country and we'll get stuck with the trash," Goulart recalled.

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