The China Food and Drug Administration issued new guidance on registration rules for 3-D printed medical devices, Emergo reports.
Here are eight insights.
1. CFDA medical device market regulators proposed specific requirements for validation and related testing for additive manufacturing products submitted for approval.
2. The guidance encompasses 3D-printed implantable devices for orthopedic and dental applications, biomaterials and pharmaceuticals produced using additive manufacturing.
3. The CFDA would require validation testing for 3-D printing manufacturing equipment and processes, in addition to software, materials and final products.
4. The guidance defines environmental parameters for additive manufacturing including temperature, pressure, humidity, gas composition, printing speed, energy density and related factors.
5. The guidance suggests product validations include usability tests, testing and evaluation for functionality and anti-pull strength and fatigue tests. Clinicians and other healthcare professionals should be involved in 3D-printed device design input and output validations.
6. Use of 3D-printed medical implants should include contracts between manufacturers, healthcare providers and patients.
7. Additive manufacturers must conduct cleaning processes. Given the complexity of 3-D printed medical devices, these processes may not be outsourced.
8. The CFDA is currently seeking industry comment and will issue a final version of the guidance to address this sector.
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