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China's Medical Device Market: New Policies, Higher Stakes

Practices: China Life Sciences

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The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes affect products at each stage of their life cycle. This paper offers analysis of the major changes, and provides insight into the organizational design and development of the regulatory affairs function at a medical device company in China.

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