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Guangdong Announces Priority Approval Criteria for Class II Medical Devices

The Guangdong Provincial Food and Drug Administration has announced that Class II medical devices conforming to any of the following requirements will qualify for priority approval when applying for first-time registration:

  • Medical devices urgently required for clinical purposes, providing there are no similar products registered in the province
  • Medical devices similar to products already available, but in such short supply that they do not suffice to cover the requirements of any public health emergency
  • Medical devices with obvious clinical advantages for the diagnosis or treatment of rare diseases or malignant tumours
  • Medical devices for the diagnosis or treatment of diseases specific to – and frequently occurring in – the elderly population, where there are no other effective diagnostic aids or treatments available;
  • Medical devices with obvious clinical advantages with regard to the treatment of pediatric patients;
  • Medical devices included in major national or provincial science and technology projects or key provincial research and development programmes
  • Applications for medical device registration submitted by major medical device manufacturing enterprises in Guangdong, including key strategic emerging enterprises and those on the province’s priority list

These priority approval procedures came into force on 1 October and will remain applicable for a period of five years.

For further details (in Chinese), please visit the following link:

Circular of the Guangdong Provincial Food and Drug Administration on Priority Approval Procedures for Class II Medical Devices (Yue Shi Yao Jian Ju Xu No. 67 [2018])

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