Making Regulatory Progress in China: Foreign Clinical Trial Data Now OK

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ARTICLE SUMMARY:

NMPA is now open to foreign data to support device submissions.

For medtech companies looking to get their products approved in China in order to be sold there, one of the more frustrating parts of the process has been that, up until recently, the NMPA (formerly the CFDA, the government regulatory agency responsible for medical devices) has required that clinical data supporting device submissions be generated from China. Foreign clinical data was not allowed. That generally meant that Western companies would have to conduct separate trials in China and rely exclusively on that data.

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