The Suggestion of Introducing the 3rd Party Review System by Reference of EU New Medical Device Regulations

In order to improve the efficiency and quality of medical device review, EU adopts the third party organization-Notify Body (NB) to review the medical device. EU promulgated and implemented new Medical Device Regulation (MDR) on May, 2017, claimed more severe and detailed requirements to the third party review organizations. This paper tries to provide suggestions on introducing medical device the third party review system in China by researching the new requirements of the NB in MDR and taking consideration of China current medical device technical review situation.