It is in 2020 that means the most extraordinary year in the history of medical device regulation. At the beginning of the year，the outbreak of COVID-19 epidemic happened unexpectedly. Under the strong leadership of the Party Central Committee and the State Council，the people of the whole country united as one and launched a desperate fight against the new coronavirus，achieving a significant victory at a certain stage. Chinese medical device industry has provided a large number of diagnostic reagents，ventilators，protective clothing，respirators and other protective products in the struggle against COVID-19，which played an irreplaceable role. Drug regulatory departments at all levels resolutely implement the “four strictest” requirements，effectively ensuring the safety and effectiveness of public use of equipment. This paper summarizes the development status of China’s medical device industry in 2020 in five aspects，which includes that China distinguished itself in the prevention and control of COVID-19；Medical device industry has been developing rapidly after the prevention and control of COVID-19；Relevant departments Implement the “four strictest” requirements to ensure the safety of public use of machinery；China promotes scientific supervision research and improves the level of medical device supervision；the development opportunities of China’s medical device industry far outweigh the challenges in the future，and prospects that the future medical device industry is still in the golden development period，so as to provide reference for the regulation and development of China’s medical device industry.