Chinese Regulators Take Steps to Ease Medical Device Registration

UPDATE October 2013: As of late 2013, the CCC mark is no longer required for medical devices. See official notification 2013 NO.52 (text in Chinese).

 

The China Food and Drug Administration (CFDA) has announced steps in recent weeks to improve its medical device classification process and ease the path to market for innovative devices.

Electronic validation for CFDA device classifications
First, the CFDA is establishing an online system for medical device manufacturers to request regulatory validation of their product classification at the provincial or central level. Previously, manufacturers unsure of how to classify their devices under the Chinese system would have to submit classification requests in writing.

Exemptions from CCC Mark requirements
Second, Chinese regulators have exempted eight categories of medical devices from requisite China Compulsory Certification (CCC) Mark certification. The CCC Mark applies to a wide range of automotive, wireless and other consumer products as well as some medical devices.

The following types of medical devices are no longer required to obtain CCC Mark certification:

  • Medical X-ray diagnostic equipment
  • Artificial heart-lung machines
  • Hemodialysis devices
  • ECG devices
  • Hollow fiber dialyzers
  • Implantable pacemakers
  • Extracorporeal blood purification devices
  • Latex condoms

 

New review process for innovative devices
Finally, the CFDA has released a draft proposal to establish a special approval process for innovative medical devices in China.  

According to China Briefing, medical device manufacturers may qualify for the proposed program if their products are the first of their kind to be registered in China and show improved safety and effectiveness compared to similar devices. Devices submitted for review under the special review system would also have to be manufactured in China.

Devices that would qualify for the new program would receive priority review status on both the provincial and central level.

Taken together, these steps show a clear intention by the CFDA to develop a less complex, perhaps even more predictable, medical device registration and approval process in China

Stewart Eisenhart