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Medical Devices / Regulatory Affairs

CFDA Issues Guidelines for Using Foreign Device Trial Data

Jan. 22, 2018

China FDA released technical guidelines for accepting clinical trial data for device trials conducted overseas, in a move to reduce duplication of trials and help speed approvals.

Devicemakers wanting to export devices to China may not have to conduct additional local clinical trials.  Previously, overseas devicemakers had to conduct an additional clinical trial in China even if multicenter trials included ethnic Chinese patients in the studies.

The guidelines are intended to accelerate and simplify the approval process, said Katherine Wang, partner at law firm Ropes & Gray in Shanghai. The change is good news for devicemakers as it provides an opportunity to reduce the time to market, Wang said.

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