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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.
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