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China’s CMDE Releases Guidance for 3D-Printed Device Registration
Devices Regulatory Affairs
China’s Center for Medical Device Evaluation issued draft guidance for the registration of 3D-printed medical devices including bone, joint and dental implants.
Registration applications should include the device’s chemical composition, including ratios of materials, and device designs be appropriately validated.
Sponsors should list the product’s intended uses, the user base and potential impact on the environment, as well as any skills, knowledge or training needed to properly use the device.