FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

AdvaMed Suggests Health Canada Revise 3D Printing Guidance

Jan. 16, 2019
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AdvaMed called for Health Canada to clarify its draft guidance on licensing requirements for implantable devices produced through 3D printing.

The association suggested that the guidance be revised to line up better with the agency’s license applications guidance, in order to clarify the different expectations for Class III and IV devices.

“The license applications guidance asks for significantly less information on manufacturing and quality controls for Class III devices,” AdvaMed said. “It is unclear in the 3D printing guidance if this expectation carries through to 3D-printed devices, or if there are higher expectations for Class III 3D-printed devices.”

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