This circular, dated 29 October 2020, specifies measures related to the review and approval of medical devices for urgent clinical needs. Such devices are to be used for the treatment of serious or life-threatening diseases with no other effective treatment. The agency will conduct priority review and if the products meet the requirements of the Guidelines for Conditional Approval of Medical Devices, such products can be granted conditional approval.
Medical devices that meet all the following conditions can be determined to be medical devices for the treatment of serious or life-threatening diseases with no other effective treatment:
(1) The product is expected to be used in the diagnosis and treatment of serious life-threatening diseases;
(2) There is currently no effective diagnosis or treatment method for the disease in China;
(3) The working principle of the product is clear, the design is finalized, and there is a certain theoretical and scientific basis of the mechanism.
(4) Clinical trial data should be able to show efficacy and can reasonably demonstrate clinical value.
The circular also specifies the additional documents required to demonstrate that the medical device fulfils the criterion above.
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