Interpretation of the decision on adjustment of the examination and approval procedures of some medi

Recently, the state food and drug supervision and administration bureau announced on the adjustment of the decision of the administrative examination and approval procedures for examination and approval matters in the medical device ", will be the third type of high-risk medical devices clinical trials for examination and approval decision, domestic class iii medical devices and medical equipment import license change decision, domestic class iii medical devices and imported medical equipment continued to register for examination and approval decision, adjusted by the state food and drug administration of management of medical equipment technical review center in the name of the state food and drug supervision and management of administration.Effective July 1, 2017.

In 2014, the food and drug supervision bureau actively to implement the newly revised regulations on the supervision and administration of medical devices, issued a "medical device registration measures for the administration of the in vitro diagnostic reagents registration measures for the administration of the third class within the territory of China and the imported medical instruments registration for examination and approval of operation specification of files, such as clear in the third class approval and imported medical device registration approval documents including acceptance, technical review and administrative examination and approval and make four link, the technical evaluation by the administration of medical devices to be responsible for the technical evaluation center, responsible for the administrative examination and approval by the administration.After the completion of the technical review of medical devices, the general administration of food and drug administration shall make the approval decision within 20 working days from the date of receipt of the technical review opinions.

Part of the technical review and administrative examination and approval of the examination and approval matters in the decisions made by the administration of medical devices technical evaluation center, to adjust the examination and approval matters, after working procedures including acceptance approval documents, technical review and administrative examination and approval, making three links, optimize the approval process.For examination and approval items adjusted, administration of medical devices technical evaluation center, after examination and approval decision of the corresponding departments in 10 working days to make the medical device registration certificate of the medical device registration change documents, approval documents will not be the administrative licensing decision etc.

To adjust some of the medical instrument of administrative examination and approval procedures for examination and approval matters, is the administration of the implementation of the medical device review spirit of the important measures for examination and approval system reform, integrating the resource of the technical review and administrative examination and approval and optimize the workflow, improve work efficiency.