Increasing access to 3D Printed Implantable Medical Devices for patients
3D printing provides opportunities for patients who need personalized customized treatments
April 30, 2019 Ottawa, ON Health Canada
Canadians want improved access to the most innovative treatment options for themselves, their families, and friends. Imagine having a medical device such as a dental implant or a bone graft designed just for you. 3D printing offers the possibility of personalized medical devices designed to meet the exact needs of patients. While all medical devices sold in Canada must meet the same standards for safety, quality, and effectiveness regardless of how they are manufactured, individually tailored medical devices can present new challenges for regulators including Health Canada.
To facilitate this emerging area of patient treatment, Health Canada today published new guidance describing the information and evidence that companies should provide when applying for a medical device licence for a 3D printed implantable medical device. Since the technology is evolving so quickly and new applications for this kind of technology are growing, Health Canada is supporting companies wanting to license 3D printed implantable medical devices by providing them with clarity on the criteria they should meet.
The guidance makes it possible for companies to use evidence from a comparable medical device manufactured in a more traditional way. The guidance also explains when new information specific to the 3D printed implantable device is required, such as when a novel design or material is used. Health Canada will continue to adapt its policy to reflect the fast pace of technological change. This guidance represents the first phase of health policy for 3D printing of implantable medical devices in Canada.
As of April 10, 2019, twenty 3D printed implantable devices have been approved for orthopaedic and dental applications, such as cranial repair or tooth replacement.
This guidance complements work underway as part of Health Canada’s Action Plan on Medical Devices. The Action Plan lays out a three-part strategy to further improve how medical devices get on the market, strengthen monitoring and follow-up for devices already in use, and provide Canadians with more information about the medical devices they rely on.
“We are committed to providing Canadians with the highest possible quality of care. Innovative technologies are a critical part of providing that high-quality care. 3D printing has the potential to provide very personalized medical solutions, and I’m excited to see how this technology can improve healthcare for Canadians while ensuring patient safety.”
The Hon. Ginette Petitpas Taylor
Minister of Health
Office of Ginette Petitpas Taylor
Minister of Health
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