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Medical Device Regulations in China

Market entry for healthcare devices in China and navigating the National Medical Products Administration (NMPA) requirements are complex endeavors but worthwhile for many manufacturers.

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Meeting China's NMPA requirements

Driven by its massive population and growing economy, China’s healthcare market is one of the most lucrative in the world and presents significant opportunities. However, understanding the regulatory landscape is critical and medical device manufacturers seeking market access must overcome notable challenges.

The NMPA has taken several steps to reduce the burden on certain products and make this process more accessible, including: 

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Implementing several regulatory reforms to streamline processes and encourage innovation
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Expanded the list of devices exempt from clinical evaluation requirements
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Introduced a green channel to expedite pre-market review, offering qualifying devices a faster route
Download our white paper

This Emergo by UL white paper answers your top questions and outlines the medical device regulations in China to help you prepare to meet NMPA requirements.

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This Emergo by UL white paper answers your top questions and outlines the medical device regulations in China to help you prepare to meet NMPA requirements.

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