Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China.pdf
Big Market Research, Big Market Research Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition) Visit for more info @ http://www.bigmarketresearch.com/latest-guidebook-for-conducting-medical-device-clinical-evaluation-and-clinical-trial-in-china-from-regulations-to-practices-market China’s regulatory framework for medical devices is undergoing radical changes. The country’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years.
Big Market Research, Big Market Research Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)
Visit for more info @ http://www.bigmarketresearch.com/latest-guidebook-for-conducting-medical-device-clinical-evaluation-and-clinical-trial-in-china-from-regulations-to-practices-market
China’s regulatory framework for medical devices is undergoing radical changes. The country’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years.
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Report Description<br />
Chapter 3 : provides a comprehensive comparative analysis to tell overseas medical<br />
device manufacturer what Ch<strong>in</strong>ese regulations on medical device registration are<br />
undergo<strong>in</strong>g radical changes, from what Ch<strong>in</strong>ese regulations on imported medical device<br />
registration are undergo<strong>in</strong>g radical changes to what overseas medical devices need to<br />
conduct the cl<strong>in</strong>ical evaluation or cl<strong>in</strong>ical trial <strong>for</strong> imported medical device registration.<br />
Chapter 4 : provides an overview of the Ch<strong>in</strong>ese regulatory authorities — Ch<strong>in</strong>a Food <strong>and</strong><br />
Drug Adm<strong>in</strong>istration (CFDA) be<strong>in</strong>g responsible <strong>for</strong> application <strong>and</strong> approval <strong>for</strong> cl<strong>in</strong>ical<br />
evaluation <strong>and</strong> cl<strong>in</strong>ical trial of imported medical device registration to give the direction<br />
of gateway <strong>for</strong> application <strong>for</strong> approval of cl<strong>in</strong>ical trial of imported overseas medical<br />
device registration.<br />
Chapter 5 : elaborates the knowledge preparation be<strong>for</strong>e consuct<strong>in</strong>g the cl<strong>in</strong>ical<br />
evaluation <strong>and</strong> cl<strong>in</strong>ical trial <strong>for</strong> imported medical device registration to let overseas<br />
medical device manufacturer underst<strong>and</strong> the unique Ch<strong>in</strong>ese approach <strong>for</strong> medical<br />
device registration <strong>and</strong> lay the knowledge foundation <strong>for</strong> the practical operation.<br />
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