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New Guidance from China FDA on 3D Printed Medical Device Registration Rules

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration has issued draft guidance on regulatory requirements for 3D-printed medical devices.
  • The guidance proposes specific requirements for validation and related testing for additive manufacturing products submitted for CFDA approval.
  • A final version of the CFDA guidance will be published once stakeholder comments have been received and compiled.

China FDA guidance on 3D printed medical device registration rulesMedical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing.

The draft guidance (link in Chinese) is intended to address longstanding questions from industry as to how CFDA will approach regulation of 3D-printed devices on the Chinese market.

Key proposals in the CFDA guidance

Among the Chinese regulator’s regulatory proposals are:

  • The scope of the new guidance covers 3D-printed implantable devices for orthopedic and dental applications; biomaterials and pharmaceuticals produced using additive manufacturing are also referenced.
  • CFDA would require validation testing for 3D printing manufacturing equipment and processes, as well as materials, software and final products.
  • Environmental parameters for additive manufacturing should be defined to include temperature, pressure, humidity, gas composition, printing speed, energy density and related factors.
  • Product validations should include usability tests, testing and evaluation for functionality, anti-pull strength and fatigue tests, and related components.
  • Clinicians and healthcare professionals should be involved in 3D-printed device design input and output validations.
  • Use of 3D-printed medical implants should involve contracts between patients, manufacturers and healthcare providers.
  • Additive manufacturers must conduct cleaning processes; these processes may not be outsourced given the complexity of 3D-printed medical devices.

CFDA is currently seeking comment from industry, and will eventually issue a final version of the guidance to address this burgeoning and complex device sector.

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