23.12.2014 Views

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 />

To enter such a lucrative medical device market, overseas <strong>and</strong> mult<strong>in</strong>ational medical<br />

device manufacturers must have a comprehensive <strong>and</strong> thorough knowledge of the latest<br />

Ch<strong>in</strong>ese regulations on medical device cl<strong>in</strong>ical evaluation <strong>and</strong> cl<strong>in</strong>ical trial.<br />

Otherwise, the restrictive legal requirements <strong>and</strong> approval delays eat up your<br />

development time <strong>and</strong> budget. <strong>Latest</strong> <strong>Guidebook</strong> <strong>for</strong> <strong>Conduct<strong>in</strong>g</strong> <strong>Medical</strong> <strong>Device</strong> <strong>Cl<strong>in</strong>ical</strong><br />

<strong>Evaluation</strong> <strong>and</strong> <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>in</strong> Ch<strong>in</strong>a: From Regulations to Practices (2014 Edition) not<br />

only provided a comprehensive <strong>and</strong> thorough knowledge of the latest Ch<strong>in</strong>ese<br />

regulations on cl<strong>in</strong>ical evaluation <strong>and</strong> cl<strong>in</strong>ical trial <strong>for</strong> imported medical device<br />

registration but also <strong>in</strong>troduced the practical operation how to comply with the Ch<strong>in</strong>ese<br />

GCP to guide you use the Ch<strong>in</strong>ese trial venues to keep medical device development lean<br />

<strong>and</strong> achieve a successful approval <strong>for</strong> your products entry <strong>in</strong>to the Ch<strong>in</strong>ese medical<br />

device market.<br />

The organizations of this guidebook are arranged as follows.<br />

Chapter 2 : <strong>in</strong>troduces the framework of the latest Ch<strong>in</strong>ese applicable regulations <strong>for</strong><br />

cl<strong>in</strong>ical evaluation <strong>and</strong> cl<strong>in</strong>ical trial of medical device registration to provide a<br />

comprehensive <strong>and</strong> thorough knowledge of the latest Ch<strong>in</strong>ese regulations <strong>for</strong> cl<strong>in</strong>ical<br />

evaluation <strong>and</strong> cl<strong>in</strong>ical trial of medical device registration.

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