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.