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.
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.
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.
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.
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.