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CHINA: Further Notice from the Hainan Government on “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area” – June 2018

CHINA: Further Notice from the Hainan Government on “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area” – June 2018

  • 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").

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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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CHINA: CNDA and Hainan Government Collaboration to Speed Up the Registration Process of Medical Devices Needed for Emergency Situations – May 2018

CHINA: CNDA and Hainan Government Collaboration to Speed Up the Registration Process of Medical Devices Needed for Emergency Situations – May 2018

  • 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

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