Doing business in China is not a simple proposition, but given the size of the market and its growth potential—the market is expected to be worth $4.5 billion in 2012 and sustain an annual 30% growth rate—it’s clearly worth the effort. Chang-Hong Whitney, president of Whitney Consulting Ltd., which assists foreign manufacturers of medical device and diagnostic products to penetrate the Chinese market, explained some of the intricacies of that marketplace at the Evolution of Advanced IVDs conference in San Diego on September 19 and 20, 2012.

 

It’s important to remember that China only has 10+ years of experience in regulating medical devices. There are bound to be some missteps and, frankly, baffling regulatory decisions.

 

Manufacturers interested in penetrating this market should be aware that reagents are approved under different regulations than medical devices, noted Whitney. Moreover, Class II and Class III reagents must undergo testing under Chinese requirements prior to product registration.

 

There are many hurdles facing makers of imported reagents from regulatory, sales and logistics perspectives, she noted. Clinical trials can be a bottleneck, she adds, because “clinical studies are a new idea in China. Many of the hospitals have neither the capacity nor the personnel to conduct them. Expect a lot of back and forth,” said Whitney.

 

So, why bother? Because, given the current expansion of the sector, “China’s IVD market will soon be the second largest in the world,” said Whitney.

 

Produced by IVD Technology and organized by UBM Canon, the conference on the Evolution of Advanced IVDs was held at the San Diego Convention Centre on September 19 and 20, 2012.