NMPA Notice On Special Review Procedures Of Innovative Medical Devices
2022-08-05
NMPA published Special Review Procedures Of Innovative Medical Devices on November 5, 2018. The implementation of this procedure has played a positive role in promoting medical device R&D innovation, the promotion and application of new technologies, and the high-quality development of the industry.
Innovative medical devices should meet the following requirements:
Applicant owns the patent rights of product core technology in China according to the law or acquires legal right to use in China;
Applicant has completed the preliminary research of the product and has a product prototype. The research process is authentic and controlled, and the research data is complete and traceable；
The main working principle or mechanism is pioneering in China, the performance or safety of the product is fundamentally improved compared with similar products, and is technically at the international advanced level with significant clinical value.
The priority and support given by the NMPA for innovative medical device:
Special personnel from the NMPA provides support with innovative medical devices to speed up the registration procedures;
Priority testing of innovative devices and issuance of testing reports;
riority for technical review of innovative medical devices, NMPA priority for their administrative approval;
Approved by the review process of registration of medical devices to apply for changes in licensing matters, the NAPA is also given priority;
Applicants can fill out the application form for communication of innovative medical devices before the registration application is accepted and during the technical review process, and communicate with CMDE on major technical issues, major safety issues, clinical trial protocols, summary and evaluation of phase clinical trial results, and other important issues that require communication.
To sum up, Special Review Procedures Of Innovative Medical Devices opens up a green channel for the registration of innovative medical devices. BradyKnows has helped many medical device manufacturers apply for the NMPA registration via the innovative medical device pathway. For more questions related to Special Review Procedures Of Innovative Medical Devices, please contact info@bradyknowsmedical.com.
