Global Regulatory Pulse

Steady Growth for China’s Medical Device Fast Track Process

In Asian Market, Consulting, Regulatory by Anney Majewski

China’s fast track process for innovative medical devices is in full speed. As of March 1, 2014, CFDA has enforced the “special approval process for innovative medical devices”1 to speed up the process for innovative medical products to get to market in China while ensuring safety and efficacy. The following are the requirements a medical device needs to obtain admittance into the fast track approval process:

  • It is considered an innovative product by the China Food and Drug Administration of Medical Device Evaluation Center,
  • The core technology invention patent is in possession or the patent application is under the State Council,
  • Significant clinical value can be proven, and
  • Technologies are advanced at the international level.

This approval process is available for both domestic and foreign manufacturers as long as the above requirements are met.1  ilable for bothve requirements are metst track approval process for innovative medical devices.val process:sed under the Stat

Since implementation, 46 products have been accepted into the fast track approval process, with 17 submitted so far. Out of these 46 products, 4 are devices from manufacturers located outside of China.2

References

  1. China Food and Drug Administration issued the “special approval process for innovative medical devices (Trial)” (2014, February 7). Retrieved February 10, 2016, from http://www.sfda.gov.cn/WS01/CL0051/96679.html
  2. Sharma, V. (2016, February 1). China’s Fast Track Process for Medical Devices Growing With 46 Products Admitted So Far. Retrieved February 1, 2016, from http://www.rajpharma.com/productsector/medicaldevices/Chinas-Fast-Track-Process-For-Medical-Devices-Growing-With-46-Products-Admitted-So-Far-362881

 

Authors:

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.