CFDA allows manufacturers to confirm medical device classes *

China - April 26 2013
In late March 2013, CFDA issued a Notice Concerning Further Improvement to Defining Classification of Medical Devices. The Notice allows the…

Co-authors: Katherine Yang, Vicki Lung, Gordon B. Schatz.

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CFDA seeks public comment on Special Approval Procedures for Innovative Medical Devices *

China - April 26 2013
China Food and Drug Administration ("CFDA," previously known as "SFDA") issued a draft Notice on Soliciting Public Comments on the Special Approval…

Co-authors: Katherine Yang, Vicki Lung, Gordon B. Schatz.

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Life Sciences Health Industry China Briefing - April 2012 *

China - May 21 2012
Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. 

Co-authors: Jay J. Yan, Mao Rong, Gordon B. Schatz, May Ling Wong.

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Notice concerning registration after adjustment of classification of medical devices — March 5, 2012 *

China - April 16 2012
If a medical device was originally registered under a higher-level classification and is now subject to a lower-level classification, the registration certificates will continue to be valid.

Co-authors: Jay J. Yan, Carrie Yang, Mao Rong, Gordon B. Schatz.

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Wholly owned hospitals established by Hong Kong and Macau service providers permitted in all major Chinese cities – March 30, 2012 *

China, Hong Kong, Macau - April 16 2012
According to China’s MOH, as of April 1, Hong Kong and Macau service providers may set up wholly owned hospitals in Beijing, Shanghai, Tianjin, Chongqing, and capitals of all provinces and autonomous regions in the mainland.

Co-authors: Jay J. Yan, Carrie Yang, Mao Rong, Gordon B. Schatz.

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