What China will say is: we're generally open to the import of medical devices, and we don't impose high duties on new devices from GE, Siemens, Toshiba or Philips. We're restricting used or refurbished products, not because we're protecting a market, but because we're concerned about quality or safety. It's a much longer, tougher argument for the WTO to prove conclusively China is wrong on safety.

Helping China change import controls

Where it stands right now: in China, they have nothing in place for their import controls to distinguish between an untested used medical device, and one that's refurbished or remanufactured, and proven to be either at a minimum quality standard, or equivalent to new.

That's where a voluntary industry standard could come in.

COCIR, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, an industry group made up of OEMs, has put forth a good refurbishing practices document. In essence, it's a pledge to follow rigorous quality management measures. It's not an industry standard, but it should lead to the creation of one.

Independent, non-OEM players tend to disfavor it: they feel it is in some respects difficult to comply with. And it is. But that's the point. China and some other countries are looking for something that's difficult to comply with, to sort out the good from the bad. If it's easy to take a piece of used medical equipment and turn around and have it considered "refurbished," it probably isn't good enough and hasn't been through rigorous quality control. [pull-quote]

And it's not just China. Brazil's concerned. Indonesia, Vietnam, Thailand, Egypt, Morocco, South Korea, Turkey and Algeria are concerned. There are a handful of countries that are advanced enough to have some regulation around medical devices and have decided to somehow restrict or prohibit import of some used goods, but are not sophisticated enough to discern used from refurbished or remanufactured.

A regulation to hang your hat on

On a global basis, COCIR's industry standard wouldn't be obligatory at all. But in markets that are otherwise closed, it gives their politicians a way to say: "OK, at least for starters, I'm going to open it for a limited extent. I'm going to use this standard as a guideline."

A big part of this is there are regulators in China who do see refurbished, remanufactured goods as a good thing - they're forward-thinking people, they know the rest of the world is taking advantage of this and saving money, but they're not. They have millions of poor people having to pay too much for health care because they have this key segment not represented there.

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