MASSDEVICE ON CALL — Chinese healthcare regulators issued a guidance on a new "Special Review and Approval Process for Innovative Medical Devices" for medical devices that represent a 1st for the country.
To quality as an "innovative" technology the device in question must satisfy certain requirements, including that it must be the 1st of its kind in China and must feature a safety and efficacy profile that is "fundamentally improved" compared with other products on the market, according to China Briefing.
The applicant must also be a legal entity in China and the primary components must be manufactured in the country. If the application is approved for the innovative medical device pathway, it will get priority status for review from China’s Food and Drug Administration.
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