Medical Devices: An Introduction to the Regulatory Regime in China and Options for Foreign Investors in the Medical Device Sector

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With the fast-growing medical device market in China, an increasing number of foreign investors are watching this industry. In this White Paper, we introduce the current regulatory environment, investment vehicles and other relevant aspects for manufacturing, trading and importing medical devices in China.

The People’s Republic of China has probably already surpassed Japan to become the second largest medical device market in the world after the United States. It is estimated that the market for medical devices in China will shortly (if not already) account for more than 5 per cent of the world market for medical devices.

As the world’s most populous country and the fastest growing economy, China offers vast opportunities for investors in a medical device market that has shown strong growth in recent years. This note provides a general introduction to the legal environment and foreign investment process in China’s medical device industry.

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