China FDA draft guidance for 3D printed medical devices

Medical device market regulators at the China Food and Drug Administration (CFDA) have proposed registration requirements for devices produced via 3D printing or additive manufacturing (AM), addressing questions regarding how CFDA will approach regulation of 3D-printed devices. The CFDA is awaiting comment from industry and will issue a final version of the guidance.

Key guidance proposals:

• Requires validation testing required for 3D printing equipment, processes, materials, software, final products
• Defines AM environmental parameters including temperature, pressure, humidity, gas composition, printing speed, energy density, related factors
• Product validations should include usability tests, testing for functionality, anti-pull strength, fatigue
• 3D-printed device design input, output validations should include clinicians, healthcare professionals
• Additive manufacturers must conduct cleaning processes in-house

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