April 25, 2012
By Aidan Petrie, Chief Innovation Officer and Co-Founder
Nine halls and a parking lot full of devices that look a lot like yours…
It is tough to walk the CMEF show and not feel daunted and overwhelmed by the challenges & opportunities Asia presents. As part of the US trade group, Ximedica traveled west to China to participate in this year’s show with a goal to understand how we could continue to support our clients, the SFDA (Chinese version of FDA), build research capabilities on the Pacific Rim and assess the opportunity to develop Asia-specific medical products for those markets. While we have maintained a small office in Hong Kong for over 20 years it has largely supported US-based programs.
CMEF itself demonstrated China’s vast industrial base and most remarkably and also sobering its ability to replicate medical devices; direct and brazen facsimiles from every company in our purview. There were no attempts to change, improve or evolve any of these devices-it was hall after hall of carbon copies. Side halls were devoted to regions and therefore less sophisticated copy shops, with 2 large middle halls devoted to international with the more sophisticated shops.
We met Conrad Wong, the head of the US Patent Office in Guangdong, and discussed what advice we should give our customers in light of these copycat capabilities. He gave us a presentation… it started with the words ‘don’t pull the rip cord’ and then went on to talk about tactics and expectations.
With this manifesto in mind we moved on to explore the regulatory landscape. Our regulatory lead, Tom Varricchione met with SFDA advisors in Beijing and learned quite a bit. SFDA is aggressively moving forward on implementing medical product regulations, including those for devices and seem intent on creating their own regulatory scheme. They recently declined to participate in the international group working on global harmonization of device regulations and their proposed regulatory scheme appears to cull elements of those from the U.S., EU and Japan. Manufacturers looking to enter the Chinese market should look forward to SFDA changes that will result in longer review times, submission of all the contents of the product’s DHF/Technical File and the strong possibility of a factory inspection by SFDA staff. All in all, the Chinese government seems to be positioning SFDA to be a “best in class” regulatory agency applying the highest review standards in the world.
Will the SFDA help clean up the market and give opportunity to the better manufacturers? Sure, and the tiered hospital system will mean that the top tier is likely to favor the name brands as is evident elsewhere in Asian markets such as autos and European luxury brands.
I asked a flagrant copy shop about IP on a device I know well and he said ‘it’s ok, patents very old’.