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Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices
Synopsis
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. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.
The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial in U.S. and EU countries. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market?
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Scope
Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical evaluation and clinical trial for imported medical device registration but also introduced the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep medical device development lean and achieve a successful approval for your products entry into the Chinese medical device market.
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Reasons To Buy
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. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.
The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial in U.S. and EU countries. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market?
To enter such a lucrative medical device market, overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device clinical evaluation and clinical trial. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.
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