The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".
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Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.
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In order to support the development of medical devices urgently needed for clinical purposes (hereinafter referred to as "emergency devices"), such as “for life-threatening cases, or diseases that may endanger public health, CMDE has released a draft of the basic principles of medical devices urgently needed in clinical purposes that may be conditionally approved to accelerate medical device listing.
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