"I would put [Brazil] in the category of more difficult," says Schorre, "mainly because their agency, called ANVISA [Agê[<00EA>][<00EA>][<00EA>]ncia Nacional de Vigilâ[<00E2>][<00E2>][<00E2>]ncia Sanitá[<00E1>][<00E1>][<00E1>]ria or National Health Surveillance Agency], does not have documents available in English, only Portuguese."

More confusing, is that what rules they do have tend not to be well-defined, or even written down, so each transaction, like a snowflake, can be totally different from the last.


"When you get in markets like the U.S. and Japan," says Schorre, "the rules are well known and defined, so people know what to expect. But in countries like Mexico, Brazil and China, even, the rules are not written, and a lot of decisions are made by independent people within the ministries at the time when the application is made. There are a lot of unknowns."

For example, he says, "It's not always clear if a product's going to be subject to tests in Brazil. You can't read a chart [to find out]. You really need a local person, who's going to definitely say that for you."

Schorre stresses the importance of having someone on the ground in the country, who knows the rules, knows the language, and has connections. "It's true in Russia," he says, "where we have an office. You have to have personal meetings to determine these requirements."

And getting all that together and tackling a myriad of potential problems may leave some manufacturers feeling a little homesick.





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