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Chinese regulators open medtech fast-track to foreign companies | MassDevice.com On Call

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MassDevice.com On Call

MASSDEVICE ON CALL — China’s Food & Drug Administration released new review guidelines allowing foreign companies to apply for the agency’s new "fast track" review, a pathway previously only accepting domestic applicants.

A draft version of the regulation, issued last year, referred only to domestic companies but the final notice published this month allows foreign companies to make use of the pathway as well, JD Supra reported.

Devices granted fast-track access will get priority throughout the regulatory process and will be assigned a "dedicated liaison" to get the application through the review process, according to the report.

Applicants must demonstrate that they are "innovative," as defined by invention patents filed in China, improved safety and performance compared to existing devices and other parameters.

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