Innovative medical devices will be given priority for approval

On March 20, the State Food and Drug Administration issued a notice seeking special approval procedures for innovative medical devices. The notification said that the State Bureau plans to set up an innovative medical device examination office and establish a library of innovative medical device examination experts to review applications for special approvals for innovative medical devices in order to encourage research and innovation in medical devices and promote the reform of the review and approval mechanism for medical device registration review Promote the development of independent innovation medical device industry.

Innovative medical devices refer to applicants as corporate legal persons in China, and products are produced in China. At the same time meet three requirements: First, the applicant has independent intellectual property rights of the product core technology; Second, the product's main working principle / mechanism of action for the domestic initiative, product performance or safety compared with similar products have fundamental improvements, technically in the international Leading level, and has significant clinical application value; Third, the applicant has completed the preliminary study of the product and has a basic stereotyped product, the research process is real and controlled, the research data is complete and traceable.

For innovative medical devices, the State Bureau will, in accordance with the principle of early intervention, special responsibility, and scientific approval, give priority to innovative medical devices and strengthen communication with the applicants on the premise that the standards are not reduced and the procedures are not reduced. The medical equipment required for emergency public health emergencies shall be handled in accordance with the “Emergency Approval Procedures for Medical Devices”.

The draft of the Opinions stipulates that the National Bureau Administrative Administrative Service Center shall establish a special examination and approval medical device application database to conduct unified management of the products for special approval. The application for special approval after acceptance is reviewed by the Innovative Medical Device Examination Office and the review opinions are issued. After reviewing the office, it is deemed necessary for further review. Experts from the innovative medical device examination expert database are selected to form an expert committee to review and issue review opinions. The results of the review are publicized on the website of the State Bureau.

The draft of the Consultation emphasized that the Medical Device Technical Review Center of the State Bureau should review the application for communication and relevant information submitted by the applicant in a timely manner and agree to communicate and communicate. It should clearly inform the applicant of the issues to be discussed and negotiate with the applicant. The form, time, location, participants, etc. of the exchange. Communication shall be recorded and the record shall be signed and confirmed by both parties for use in subsequent research and review of the product.