Class I medical device products for the record, do not need to conduct clinical trials. Application for registration of Class II and Class III medical device products, should be conducted clinical trials; however, one of the following circumstances, can be exempted from clinical trials:
(1) the working mechanism is clear, the design is finalized, the production process is mature, and has been listed in the clinical application of the same varieties of medical devices for many years and no record of serious adverse events, do not change the routine use of the device;
< p>(2) through non-clinical evaluation can prove that the medical device is safe and effective;(3) through the clinical trials of the same variety of medical devices or clinical use of the data obtained by analyzing and evaluating, and can prove that the medical device is safe and effective.
Exempted from clinical trials of medical devices catalog by the State Council Food and Drug Administration to develop, adjust and publish.
Medical devices
Medical devices refer to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software.
Medical devices include medical equipment and medical consumables.
Efficacy is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in a secondary way.
Refer to Baidu Encyclopedia for the above Baidu Encyclopedia - Notice on the Release of the Second Catalog of Medical Devices Exempted from Clinical Trials