China’s regulatory scheme for medical devices is rapidly evolving. In 2016 the country’s centralized Food and Drug Administration (CFDA) released 71 regulatory documents for medical devices.
Dealing with the complexities of China’s central and provisional governments has always been difficult. Now, changes are coming so quickly it’s hard to keep up.
Today’s Chinese medical device market is not the same one you knew 20 or even 10 years ago. The regulatory system is undergoing a renaissance as the CFDA updates its GMP requirements with an eye to better aligning with US and international standards, increasing R&D and encouraging innovation.
Navigating China’s Medical Device Regulations brings you up to date, explaining how the Chinese system and culture work, what the regulatory changes are, how to react to new requirements and what may come in the future. The management report covers:
CFDA’s newly released documents
Statistics on CFDA device approvals and rejections
The structure of China’s medical device regulatory system
How China’s GMP policies compare with the US, Europe and Japan
Why and how CFDA conducts unannounced inspections of device manufacturers
The schedule for compliance with new regulations
Where devicemakers most often run afoul of the new rules
Order your copy of Navigating China’s Medical Device Regulations to understand China’s regulatory structure and new focus on R&D and innovation.
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PDF Edition — $397
Who Will Benefit
Manufacturing directors and supervisors
Regulatory/legislative affairs professionals
Strategic planning and business development staff
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