Rest of world not much laxer

While U.S. and Europe are the biggest markets for medical devices, the rest-of-world is increasingly luring OEMs eager for a slice of their growing economies.


Predictably, some of these countries have lax regulations - India, for instance, has yet to establish solid medical device regulatory law, the largest country on the planet - teeming with some 1.3 billion people - that is yet to do so. But that doesn't mean rest-of-world markets are the Wild West and offer shadily streamlined paths of regulatory ease. India is the exception, not the rule. In fact, secondary markets have regulations that while sometimes ad hoc and variable are actually rather tough - and often keep a lot of advanced med tech off the market.

First, most countries have anti-dumping laws in effect that require medical device makers to have home-country approval for products to be sold. While this prevents sale of defective products, it also allows smaller, poorer countries to basically save money by "outsourcing" their testing to places like the U.S. or Europe.

"They look at U.S. approval and the European approval as something they can trust," says Schorre. "They figure all the hard work has been done. They don't have to hire experts. The Americans have done it."

And what new regulatory hoops they do string up are less to ensure medical products are reliable, and more to protect home industries.

"They'll put these little bells and whistles and requirements on things," says Schorre. "Some of the things they do are protectionist, requiring lots of additional testing in the market." As an example, he mentions that Russia requires electrical-safety testing to be done to their own standards, using Russian test facilities, even though these standards "are almost identical to international standards for electrical safety."

These protectionist measures could even slow down imports, as many medical device companies are reluctant to incur the big expense - and hassle - of enduring what is often redundant foreign testing. "If only the world would harmonize on certain things," says Schorre. "The end result is that a lot of secondary markets don't get the medical technology they could get, because they make the registration process difficult. Leading-edge tech does not make it into some of these secondary markets for that reason. It's too bad."

But one of the main snags isn't legal: it's linguistic - and cultural. Take Brazil and China, the number one and number two, respectively, most favored countries for medical companies to export to in 2010, according to a survey just conducted by Emergo Group, which kindly agreed to share early numbers with DOTmed News. These two countries, unlike say, most European nations, don't offer guidebooks in English.

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