In this whitepaper Qserve shows the most common questions and answers about the Chinese Medical Device Regulations NMPA. Do you have thoughts or doubts about entering the Chinese market? Our years of experience and our professional international China team allow us to share real experiences and advice.
What to expect in this whitepaper about Market Access in China:
- Why is China an attractive market for medical devices and in vitro diagnostics?
- What are the three pros of entering the Chinese market?
- What are the major challenges for foreign applicants to enter the Chinese market?
- What are the top three common misconceptions foreign manufacturers have about entering the Chinese market?
- Why is it essential to establish a global strategy early on for entering multiple markets?
- What advice is beneficial for a manufacturer of medical devices or in vitro diagnostics considering expansion into the Chinese market?
- What are the common gaps between the requirements for medical devices in the US and the EU compared to the Chinese regulations?
- What are the common gaps between the requirements for in vitro diagnostics in the US and the EU compared to the Chinese regulations?
- Which regulations from other key markets are best suited to China?
- What is the role of the NMPA (National Medical Products Administration) in China?
- What is the role of CDME (Center for Medical Device Evaluation) in China?
- What are the possible submission pathways in China?
- Are there regional differences in regulations in China?
- What classification method is used in China?
- What is the responsibility of the China Agent?
- What is the role of a distributor?
- What is the difference between a distributor and a China Agent?
- What is the minimum budget you need to consider entering the market?
- What is the average lead time to enter the market?
- At what stage is it best to consider market access in China?
- What are the latest regulatory updates in China?
Fill in your details and download the Q&A.
Additional information on our website: