China, Russia build new barriers for foreign medical device manufacturers

09/24/2014

The remarkable rise of China's middle class, which by some accounts is equivalent to the entire population of the United States, has created massive consumer demand where there was none just a couple of decades ago. In the medical device space, this economic and demographic shift has led many medtech manufacturers with a presence in China to place greater focus on producing goods for the domestic market than for export. The Chinese government, however, has increasingly put pressure on hospitals and other purchasing groups to favor devices made in China by Chinese companies. A similar move is underway in Russia, where a draft regulation published in March 2014 seemed to presage an almost complete ban on the purchase of foreign medical devices. A new draft tones down the restriction, but still places obstacles in the path to market for foreign-made medical products.

New Russian manifesto
The initial draft regulation in Russia was, to put it mildly, harsh. It seemed to mandate a "virtually complete ban on foreign medical devices from state and municipal purchases," writes Sergey Klimenko of the Pepeliav Group (Moscow), a law firm that provides legal support for foreign direct investment projects, on www.lexology.com. However, it avers that the draft was meant more as a conversation starter for stakeholders, and a second, more-nuanced draft was published a little later.
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