China’s State Drug Administration is implementing a new device review procedure to bring innovative devices to market faster and to encourage more innovation in China’s supply chain.
The new Special Examination Procedure for Innovative Medical Devices, which becomes effective Dec. 1, aims to improve the efficiency of device reviews and inspections.
The new special examination procedure replaces the green channel special approval process launched in 2014. The document refines the application process, improves the initial review and prioritizes licensing requirements for innovative devices.
To be eligible for the innovative device review, applicants must have legal rights to the core patent technology inventions in China. Manufacturers should submit applications no more than five years after a patent has been granted.
Another requirement is that the main working principle or mechanism of the product should be a first in China. The product performance or safety should be fundamentally better than current products on the market and it should be comparable to international standards and have significant clinical value.
Domestic companies will submit applications for an initial review to their provincial FDA, which will be reviewed within 20 working days. The provincial FDA will then submit the application materials and the preliminary examination opinion to the State Drug Administration for review.
Foreign applicants should submit applications directly to the State Drug Administration.
The SDA’s Medical Device Technology Evaluation Center will establish a separate Innovative Medical Device Examination Office to review innovative medical device applications.
Sponsors will be able to participate and communicate with experts through video conferencing. The appraisal center has already carried out pilot projects in some provinces and cities, and has invited experts to hold special review meetings via remote video for innovative devices.
Once an application is submitted, manufacturers can check the progress of the review by logging in to the website of the National Bureau of Testing. Paper notices will no longer be printed after the new procedures are implemented.
After receiving the application, the Innovative Medical Device Examination Office will issue a review opinion within 60 working days.
Before the product registration application is accepted and during the technical review process, the inspection center will designate a person to promptly communicate and provide guidance to the applicant on technical issues.
The SDA will conduct good clinical practice inspections to review the clinical trial plan, use method, specification model, intended use, scope of application or adjustment of population, and safety and effectiveness of the device.
China’s inspection agencies will give priority to inspections for innovative devices.
Read the SDA notice here: www.fdanews.com/11-08-18-ChinaInspections.pdf.