China's FDA created and issued a series of draft requirements for 3-D printed health devices to gain regulatory approval, Emergo reports.
Here's what you should know.
1. The guidance is designed to address how the CFDA will address 3-D printed devices on the Chinese market.
2. The scope of the guidance covers implantable devices for orthopedics and dental. It also references biomaterials and pharmaceuticals produced using additive manufacturing.
3. CFDA is requiring validation testing for 3-D printed manufacturing equipment and processes. It's also testing materials, software and final products.
4. According to the CFDA, environmental parameters for additive manufacturing should be defined to include temperature, pressure, humidity, gas composition, printing speed, energy density and other related factors.
For more information on the approval process, click here.
https://www.emergogroup.com/blog/2018/03/new-guidance-china-fda-3d-printed-medical-device-registration-rules-0