In recent years, the review and approval process of drugs and medical devices in my country has been continuously improved to ensure their safe listing. However, the rapid development of medical engineering technology and the improvement of patients’ needs have posed higher challenges to the review and approval of drugs and medical devices. For example, in order to ensure safety and effectiveness, the review and approval time is too long, resulting in the loss of timeliness of drugs and medical devices; too many applications, shortage of reviewers and insufficient professional level; review and approval process is too complicated, etc.
Therefore, it is recommended to revise the drug and medical device product registration regulations, update the review and approval process according to the needs, take strictness as the main policy, efficiency as the evaluation indicator, strengthen the construction of the review team, and increase the number of reviewers. At the same time, the review and approval of domestic innovative drugs and medical devices should be accelerated to promote their listing as soon as possible and break the monopoly of imported products. In addition, medical devices can be reviewed and approved according to risk management categories, simplifying the review and approval process for low-risk products and better ensuring the quality of high-risk products.