[Heavy] CFDA exempts 359 medical device clinical trials (with list)

Recently, the State Food Drug Administration through extensive research, public consultation, full research and feasibility studies, in ensuring the safety of medical devices, effectively, a expanded from clinical trials of medical devices range, recently issued a "release The second batch of notices exempt from the clinical trial medical device catalogue (Notice No. 133 of 2016 of the Food and Drug Administration) will be implemented as of the date of promulgation.

The second batch of medical devices exempted from clinical trials has a total of 359 products, including 267 second-class medical devices and 92 third-class medical devices. For products listed in the above catalogue, the registered applicant may not need to carry out clinical trials, and should submit relevant information and comparative information of the declared product when applying for registration.

The following is a list of the second batch of medical devices that are exempt from clinical trials:

Catalogue of second-class medical devices exempt from clinical trials (second batch)

Large Canopy LED Panel

PDT Beauty Machine lamp 660nm 850nm Full Body Red Light Therapy Panel NIR Light Therapi Device

Red LED light therapy equipment for plastic surgeons, dermatologists, estheticians, and other licensed skincare and wellness professionals.

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