China Eases Medical Device Renewal and Clinical Trial Requirements

Renewing medical device registrations in China just became more simple. Moving to expedite the introduction of important new technologies to market, regulators announced this summer that they will require less documentation on sales data and post-market inspection reports from device makers seeking to extend their presence in the Chinese market.

The eased rules also apply to applications to conduct medical device clinical trials. Device manufacturers are no longer required to provide proof of home country approval in their clinical trial applications. And while China has long required approval by ethics committees at each institution where clinical trials are conducted, manufacturers running clinical trials at multiple sites will now only need approval from the ethics committee at their lead trial site.