How to Get Your Medical Device into China

By Ping Poulsen


Getting your medical device approved by the CFDA in China can seem overwhelming. How do you begin to validate the market, protect your IP, navigate the regulatory process, and eventually generate revenue?


Here are three tips:

  1. Build relationships — Laws are important in China, just as they are in other countries. In addition, China is a country of business relationships. Therefore, it is essential to develop relationships early on in the regulatory process. Identify whom you are going to work with and/or partner with early.
  2. Understand the market — Setting up distribution can be the most difficult and time-consuming task. Conduct research by phone and through personal contacts. Frequent face time and in-person contact is crucial to understand the market.
  3. Leverage a partner — The fastest way to build relationships and understand the market is to work with a partner who is experienced with the Chinese regulatory process. Don’t go it alone. Work with someone who has experience and relationships.


For more details, view this video on the Safis Solutions YouTube channel: How to Sell Your Drug or Device in China


For information about working with Safis Solutions to get your medical device into China, go to Regulatory Approval for Medical Devices in China.


Ping Poulsen founded Safis Solutions, LLC and serves as President and CEO. 
Share this:

Leave a comment..