NMPA Innovative Medical Device Review And Emergency Review
2022-03-08
Ⅰ.Innovative Medical Device Review
1. The significance of the Special Evaluation and Approval Procedure for Innovative Medical Devices (IMD)
(1). To encourage the research and innovation on medical devices
(2). To facilitate the promotion and application of new technologies in medical devices
(3). To accelerate the development of medical device industry
2. The requirements for the application of Special Evaluation and Approval Procedure for IMD
(1). There are three prerequisites:
Through their predominant technological innovation research, the applicants/registrant legally own the patent right of the product core technology invention in China.
The applicants/registrant can obtain the invention patent or use rightin China by legal transfer.
The application for the core technology invention patent has been disclosed by the Patent Administration Department.
(2). The main working principle or action mechanism of the product is the first in China. The product performance or safety has radical improved compared with predicate device. The technology is at the international leading level and has significant clinical application value.
(3). The applicants/registrant have finished the preliminary research of the product, and have basic stereotyped products. The research process is authentic and controlled, and the research data is complete and traceable.
The benefits of applying for Innovative Medical Devices.
CMDE will intervene early, and all processes will be accelerated.
CMDE will assign reviewer to participate.
Giving Priority to the test, system examination, evaluation and approval.
Flow chart of special review for IMD
3.TIPS
The application for special review for IMD must be submitted prior to registration application for medical devices
Class I medical devices cannot be applied for special review for IMD
Application for special review of IMD is not applicable for the renewal of registration and changes in licensing items do not apply
No application fee is charged for special review for IMD.
Ⅱ.Emergency review
1. What is emergency review
When there is a threat of public health emergencies and the occurrence of public health emergencies, in order to effectively prevent, control and eliminate the hazards of public health emergencies in a timely manner, and ensure that the medical equipment required for emergency can complete the registration and approval procedures as soon as possible.
2.Which medical devices are in the scope of emergency review
Required for emergency response to public health emergencies
There are no similar products listed in China, or although similar products have been listed in China, the product supply cannot meet the emergency treatment needs of public health emergencies
