China is where many medical device companies are looking to sell products by capitalizing on growth opportunities.
But in recent years there has been an added wrinkle. And that has grave consequences for medical device manufacturing processes in the U.S., said Kem Hawkins, president of Cook Group at the MedCity CONVERGE Conference Tuesday in Philadelphia.
The Asian nation is requiring any imported medical device to be registered for sale in China be approved in the nation where it is being manufactured. In other words, if the imported product is being manufactured in the U.S., it needs to have marker clearance domestically before it can be registered for sale in China. It’s part of the so-called “country of origin” requirements.
Now, it’s not news that the U.S. device industry in the past decade has been frustrated by the slow pace of approvals at the Food and Drug Administration. For instance in 2004, the FDA granted 46 premarket approvals and by 2009 it was down to 15.
Hawkins did acknowledge, however, that in 2010 the agency granted 31 PMAs. But even with more products getting approved lately, the pace of product approval is still faster in Europe where third party reviewers approve products instead of a single agency.
So far the slower rate of approval in the U.S. had only consequences for U.S. patients, Hawkinssaid. That’s because they they wouldn’t be the first to access innovative, life-saving technology.
But now the country of origin requirement is having an affect on manufacturing jobs because companies are either moving or going to move manufacturing outside the U.S., Hawkins declared. Presumably it is not practical to wait to get approval from the FDA before products can be sold in China.
What is more troubling is that other nations are considering this kind of country of origin rule too. That includes Brazil, Hawkins said.
“I hope this is a wake-up call for the FDA,” to speed up product approvals, Hawkins said.
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By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
Hooray for country of origin rules like these, that keep products for which safety and effectiveness are not yet proven to FDA's satisfaction off the market in other markets than just the US. If companies want market clearance sooner, they should get their regulatory ducks in a row and file as soon as possible with good and complete data to avoid clock-stops. The US medical device industry leads the world *because* of our strong regulations and resulting reputation for maximized device safety and effectiveness.
One hopes that the Chinese require soon that imported products originating in countries with weak regulatory systems also meet the more rigorous US FDA requirements, so that Chinese medical consumers are protected from the kinds of companies that would give short shrift to safety and effectiveness by moving production out of the US.