Regulatory Requirements For Medical Devices In China

As the most populous country in the world, China’s medical device market has maintained a double-digit growth for more than 10 years. While there may be some economic challenges and uncertainties in the near future, due to its market size and aging population, China still offers a wealth of opportunities for foreign medical device companies. 

One of the greatest difficulties for foreign medical device companies in China is its complicated and stringent regulatory requirements. Despite some improvements recently, gaining market access to China for medical device products still takes more than 18 months. As such, successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.