AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing or 3D printing.
The group argued for the several revisions outlined in its comment to Health Canada—submitted on Tuesday—to “better reflect the manufacturing process flow,” avoid confusion around use of the term “validation” and address the emerging trend of point-of-care 3D printing.
Revisions are also needed to ensure consistency with the final version of a document developed by the International Medical Device Regulators Forum (IMDRF) on harmonized definitions for personalized devices. This is because Health Canada issued its draft guidance on 3D-printing implantable devices shortly after the IMDRF document was finalized in November 2018.
The IMDRF final document largely favored using the term “patient-matched” versus the draft version’s use of “patient-specific” devices. The change was necessary “as ‘patient-specific’ could be misconstrued as ‘custom-made,’ whereas ‘patient-matched’ is more descriptive of the devices in this category,” said AdvaMed associate vice president of technology and regulatory affairs Jamie Wolszon. Yet this change was not reflected in Health Canada’s draft guidance, despite being among the IMDRF member agencies.
The draft guidance does seek to harmonize Health Canada’s new policies by adopting the IMDRF definitions for personalized devices, but it refers to the proposed document from March 2018. It uses both the terms “patient-specific” and “patient-matched” interchangeably, which could in turn cause confusion.
“Given the ever-growing prevalence of 3D techniques in global manufacturing of medical devices, we appreciate Health Canada’s work on this issue both inside and outside of Canada,” Wolszon added. “We hope that our comments can help inform Health Canada’s current thinking, both as it relates to its own regulatory regime and as it participates in the harmonization effort with its fellow regulators at IMDRF.”
The terminology around 3D-printing is just one of the challenges IMDRF regulators have sought to address as it is still a relatively new manufacturing technique in the medical device space…