Getting priority for quality management system inspection.
Getting priority on the waiting list for evaluation and approval.
Getting special channel for communication.
2. Conditions for application
The National Medical Products Administration implements the priority evaluation and approval policy for registration of domestic medical devices of Class III and imported medical devices of Classes II and III which meet one of the following conditions:
(1). The medical devices which satisfy one of the following conditions:
The medical devices for diagnosis or treatment of rare diseases and with obvious clinical advantages.
The medical devices for diagnosis or treatment of malignant tumors and with obvious clinical advantages.
The medical devices for diagnosis or treatment of diseases which are endemic to and prevalent in the elderly and against which the existent diagnosis or treatment approaches have been ineffective.
The medical devices specific to children and with obvious clinical advantages.
The medical devices which are in urgent clinical need and there is no similar product available in China.
(2). Medical devices under the national major scientific and technological projects or the national key research and development programs.
(3). Other medical devices that should be subject to priority evaluation and approval.
3. Priority evaluation and approval flowchart of medical devices
4. TIPS
Objections to the publicized proposal shall be discussed by CMDE within 10 working days upon the receipt and both the applicant and the opposition will be notified of the conclusions.
For rejected applications, the CMDE shall notify the applicant of its opinions and reason of disapproval, and handle the case according to regular evaluation and approval procedures.
The Priority Evaluation and Approval Procedure for Medical Devices shall not apply to products which have gone through emergency evaluation and approval procedures or special evaluation and approval procedures for innovative medical devices.
