Innovative medical device research and development brave "no man's land"
On January 4, the official website of the Medical Device Technology Evaluation Center of the State Drug Administration (hereinafter referred to as the Appraisal Center) issued an announcement to initiate a collective decision-making mechanism for the conclusion of the technical review of medical device registration, and form a rectification notice for the group review project through collective discussion. Single and initial registration, change of registration of licensing items and review of clinical trial approval projects.
Memorandum of work on medical device supervision in 2019
Editor's Note From January 21 to 22, the National Medical Device Supervision and Management Work Conference was held in Beijing. The meeting deployed the key work of medical device supervision and management in 2019, aiming at protecting and promoting the safety of public equipment, comprehensively deepening the reform of the examination and approval system, focusing on strengthening the whole life cycle management, and promoting the development of regulatory science. Grasp the hand, adhere to risk management, strengthen the implementation of responsibility, promote smart supervision, further improve the scientific, legal, international and modern level of medical device supervision, and earnestly safeguard the safety of public equipment. In this issue, we will sort out the medical equipment registration and post-marketing supervision work in 2019, so stay tuned.