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Shanghai Specifies Priority Approval Requirements for Class II Medical Devices

New priority approval procedures for Class II medical devices – those whose use is deemed to require a degree of professional supervision – have been adopted in the Shanghai municipal area. Details of the procedures, which came into effect on 1 September this year, were released by the Shanghai Municipal Food and Drug Administration. The new regulations – The Priority Approval Procedures of the Shanghai Municipality for Class II Medical Devices – will remain in force for the next five years.

In line with these procedures, Shanghai will prioritise the approval applications of Class II medical devices that meet one of the following requirements:

  1. Medical devices included in national or municipal science and technology major projects or key research and development programmes
  2. Medical devices with obvious clinical advantages for the diagnosis or treatment of rare diseases
  3. Medical devices for the diagnosis or treatment of diseases specific to, and frequently occurring in, the elderly population, where there are no other effective diagnosis aids or treatments available
  4. Medical devices with obvious clinical advantages with regard to the treatment of children
  5. Medical devices deemed to meet urgent clinical needs
  6. Any other medical device that clearly merit priority approval

Additionally, any products designated by the China Food and Drug Administration as Class II medical devices will also be granted priority approval in accordance with the specified procedures.

For further details (in Chinese), please refer to the following website:

Shanghai Municipal Food and Drug Administration, Hu Shi Yao Jian Gui No. 3 [2017]

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