China Medical Device Regulations NMPA

Interesting and challenging

China Medical Device Regulations

Market access to China, with differences in language, culture, and compliance, could be challenging and require knowledge and support. 
Due to its large base population and growing aging population, China is a compelling healthcare market that presents numerous opportunities for foreign companies. However, understanding the practicalities of accessing the market and the China medical device regulations is not simple. It is challenging for many medical devices and in vitro diagnostics manufacturers to meet the dynamically updating regulatory requirements. 


Regulatory Compliance

Qserve China

With our multilingual regulatory experts based in Nanjing and Bejing, our consultants have helped many venture startups and multiple national corporations in China and abroad with China Medical Device Regulations successfully obtain regulatory approval with the NMPA registration process since 2011. 

By working directly with the China Health Authority and maintaining regular contact with local test engineers, authority officers, and technical reviewers, our regulatory experts are fully aligned with regulatory compliance, able to identify gaps, find solutions, and provide you with one-stop service support until the certificate is obtained. 

How can we help you?

China Medical Device Regulations

As a multi-lingual, highly experienced team with close ties to the local industry and associations, we help foreign medical device manufacturers with their medical devices and in vitro diagnostics to sell them in China and support China Medical Device Regulations. We can help you expand or change the existing distribution network.

• Build a regulatory strategy plan
• Act as independent legal representation China Agent
• Offer extensive international and local networking
• Direct communication with the reviewer before and after submission
• Clarify the gaps between China's requirements and other countries

We are pleased to be your experienced and dedicated China partner. Do you have questions about China compliance? There is always time for a free introductory call to share your thoughts.  

Contact us