(Reuters) — The FDA said last week that it expects China, after almost 2 years of delays, to soon approve visas that will allow the agency to more than double its staff in China.
China Food & Drug Administration (CFDA)
Mazor Robotics wins China OK for Renaissance robotic surgery device
Cook Medical launches China trial for Zilver PTX peripheral stent
Cook Medical said it enrolled the 1st patient in a 1st-of-its-kind clinical trial in China for its Zilver PTX drug-eluting peripheral stent as it looks to win approval for the device in the People’s Republic.
FDA meeting over uterine surgical device and cancer risk sparks debate | Regulatory news for the week of July 14, 2014
Merit Medical wins China OK for Aero device
April 2014 Medical device recalls | Medtech regulatory news for the week of May 5, 2014
Medical device recalls for April 2014
May 2, 2014 by Arezu Sarvestani
April Summary
Class I recalls: 7
Class II recalls: 203
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Medical device regulatory changes in China: Emergo group analysis
By Stewart Eisenhart, Emergo Group
Chinese medical device revisions nearing implementation
By Stewart Eisenhart, Emergo Group
The Chinese government’s State Council Executive Committee has approved updates (link in Chinese) to the country’s medical device regulatory system, bringing the long-awaited revisions closer to actual implementation.
China announces expedited market authorization for innovative medical devices
By Stewart Eisenhart, Emergo Group
The China Food and Drug Administration (CFDA) will launch an expedited registration process (link in Chinese) on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country.
Chinese regulators open medtech fast-track to foreign companies | MassDevice.com On Call
MASSDEVICE ON CALL — China’s Food & Drug Administration released new review guidelines allowing foreign companies to apply for the agency’s new "fast track" review, a pathway previously only accepting domestic applicants.
Boston Scientific puts more skin in China
Boston Scientific (NYSE:BSX) is looking to stimulate its China division through a series of acquisitions and a workforce boost that the medtech giant hopes will help it claim a bigger part of the Chinese market.