2014 is a monumental year for China and the way it regulates the marketing and distribution of Medical Devices within its borders. This is the first major overhaul of the regulatory system since 2000. Changes to the system include new industry standards and amendments to the current regulations. In this whitepaper the current state of China’s healthcare market and the current market clearance process for medical devices will be summarized. Then an overview of the changes scheduled to be enforced starting October 2014 will be provided. A review of the new challenges this creates for market clearance of medical devices in China, the impact this has on language and what considerations must be made will also be discussed.