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China Medical Device Regulations NMPA

We can guide you through the complete NMPA Medical Device approval processes in China

Market Access China

NMPA registration process

Since 2018 the National Medical Products Administration (NMPA) has been created and responsible for regulating medical devices in China to replace former China's State Food and Drug Administration (CFDA). Understanding the China medical device regulations can be complex and the regulatory environment is dynamic. If you want to have market access in China with your products, the NMPA plans and standards for the quality and safety of medical devices. 

Qserve
 can help you obtain regulatory approval for your medical device or In Vitro Diagnostics (IVD) in China. Our experts work directly with the China Health Authority, coordinating the submission of regulatory files and answering feedback from the Health Authority.

 

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Interesting and challenging

Market access to China with differences in language, culture and different compliance, could be challenging and requires knowledge and support. 

Due to the large base population and growing aging population China is a compelling healthcare market and presents numerous opportunities for foreign companies. However, understanding the practicalities off accessing the market and understand the China medical device regulations is not simple. It is challenging for many medical device and in vitro diagnostics manufacturers with the dynamically updating regulatory requirements. 

Qserve China

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

By working directly with the China Health Authority and maintaining a 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 the one-stop service support until the certificate is obtained. 

Regulatory routes

What's the most common route to enter the Chinese market?
There's a difference between the regulatory route for foreign manufacturers and domestic manufacturers. In addition to the standard regulatory routes for market entry, there are several supplementary approval routes for faster approvals. 

Qserve leads foreign manufacturers and domestic manufacturers to the complete approval process, or filling process at the NMPA (former CFDA), and obtains a product certificate registration process. 

Regulatory routes

China Agent

To access the Chinese market with a medical device, you must acquire the Medical Device Registration Certificate from the National Medical Product Administration (NMPA). In case you do not have a subsidiary in China, you have to appoint a local legal agent to deal with registration and after-sales service.

We help foreign medical device manufacturers in our role as China agent with our practical approach.

China agent

Free Compliance Check

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.

Through extensive international and local networking and our practical approach, we can help you expand or change the existing distribution network.

Do you want to know all the impacts on your company? We provide a free compliance check.

China Compliance check

 

 

How can we help you?

  • 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 requirements and other countries

We are pleased to be your experienced and dedicated China partner. Do you have questions about China compliance? Or would you like to very your thoughts? 

Contact us

Expand your knowledge

Watch the On-Demand recording where Stephanie Huang (Qserve China Agent) explains the Medical Device Registration in China (video recorded June 2023) and addresses the following topics:

  • Medical device governing body
  • Classification
  • Registration and filing
  • Domestic and imported devices
  • In-country representation
  • Certificate validity and renewal
  • QMS requirements

Watch the video

 

China Agent information

Download the China Agent leaflet to read more about Qserve's role as an independent China Agent. 

Download leaflet