[netizen red rainbow] in the medical device license, the state of medical devices to implement pre-market licensing system, may I ask the new revision of the "Regulations" and the original "Regulations" in the registration and approval of the link what are the changes?
[Gao Guobiao] Secondly, according to the relevant provisions of the original "Regulations", the territory of the manufacturer should first obtain a medical device production license before registration declaration. The new "Regulations" provide that the applicant for new registration in the territory of the establishment of the production of medical devices in line with the quality management standard such a quality system, and can maintain the effective operation of the premise, in order to ensure that the product design, the research process can meet the requirements of the quality management system, you can apply for registration directly without having to obtain a production license first. The design and change of such a system, it can be said that the applicant for registration to avoid the first production license, and then apply for registration and lead to the need to spend a lot of money to invest, resulting in the production plant, equipment restrictions waste. With the promulgation and implementation of the new "Regulations" will highlight a big change, in fact, play a role in encouraging the research and innovation of new medical device products.
Responsibility Editor: Hu Guoxiang