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  • Latest Technical Review Guidelines Issued / Updated

Latest Technical Review Guidelines Issued / Updated

Thursday, 22 October 2020 / Published in Medical Device, News, NMPA Registration in China

Latest Technical Review Guidelines Issued / Updated

 In September 2020, the NMPA issued the following guidelines:

  • Technical review guideline for balloon dilation catheters
  • Technical review guideline for infusion products with sharp injury prevention features
  • Fatigue performance evaluation guideline for bio-type femoral stems
  • Guideline on the validation of virus inactivation for allogeneic transplants (amended 2020 version)
  • Guideline on reviewing the registration of 3D-printed lower jaw prosthesis
  • Guideline on quality control for customized bone implants and tools
  • Guideline on reviewing the registration of single use pen needles (draft)

By Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: allogeneic transplants, balloon dilation catheters, bone implants, infusion products, lower jaw prosthesis, pen needles, stems, Technical Review Guidelines

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