Dec 2, 2015

The US and Chinese governments have agreed to several measures that would provide faster and more transparent market access in China for foreign medical device manufacturers.

The agreement was reached during bilateral trade talks at the US-China Joint Commission of Commerce and Trade held in Guangzhou, China that covered various agricultural and manufacturing issues.

The two governments agreed to multiple measures aimed at reducing medical device application backlogs in China and speeding up Chinese market authorization pathways. Specific measures include:

  • Expanding Chinese clinical trial exemptions for more Class II and III medical devices in 2016
  • Dedicating more Chinese Food and Drug Administration (CFDA) resources and staff to review innovative medical devices
  • Improving communications and consultations with medical device registrants
  • Establishing a minimum timeframe of 30 days for public comment prior to implementation of any new rules and regulations by the CFDA
  • Handling imported medical devices in the same manner as devices manufactured in China
  • Publishing annual reports on CFDA medical device reviews and Chinese regulatory performance

These agreements follow initial discussions between US and Chinese trade representatives in late 2014, as previously reported by Emergo. Although Chinese medical device market authorization entails an expensive and complex process for foreign manufacturers, these new measures should add more consistency and clarity to that process.

Chris Schorre, Vice President of Global Marketing at Emergo, says foreign manufacturers should be encouraged by the new agreements.

“We hope evaluating the ongoing performance efforts of the CFDA will include metrics for how long it takes the CFDA to review applications, how many applications are approved, and why applications are rejected or delayed,” Schorre says.

“It’s also very encouraging to see the issue of clinical trial exemptions addressed,” he continues. “We have many medical device clients interested in entering the Chinese market that abandon their efforts once they learn that a clinical trial in China will likely be required. This can greatly increase the total cost of compliance with CFDA regulations.” 


  • Stewart Eisenhart