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CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

  • 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

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CHINA: CMDE Releases the Draft of Basic Principles of Medical Devices Urgently Needed for Clinical Purposes – May 2018

CHINA: CMDE Releases the Draft of Basic Principles of Medical Devices Urgently Needed for Clinical Purposes – May 2018

  • 2020-02-14 07:33:20

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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