is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, April 24th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.
This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.
Showing posts with label Asia Pacific Bio Intelligence. Show all posts
Showing posts with label Asia Pacific Bio Intelligence. Show all posts
Wednesday, April 18, 2012
Monday, March 5, 2012
Industry Update – China's Evolving Medical Device Regulations
is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, March 13th, 2012. For more details, or to register please visit our site at www.fxconferences.com
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
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