Canadian medical device market regulator Health Canada has published a new round of updates regarding its Medical Devices Action Plan (MDAP), reporting progress not only on authorizations and approvals for coronavirus-related devices and clinical trials, but also for high-risk devices, investigational testing applications and special access requests.
Launched in late 2018, Health Canada’s MDAP targets three key pillars:
Pillar 1: Improving safety and effectiveness of medical devices and their access to the Canadian market;
Pillar 2: Strengthening post-market monitoring and follow-up of devices used by Canadian healthcare providers and patients;
Pillar 3: Providing more information to Canadian healthcare providers and patients about medical devices they use.
Although the COVID-19 public health emergency has commanded major effort and resources from Health Canada, the regulator was still able to address other longstanding goals of the MDAP during 2020.
Key Health Canada MDAP progress in 2020
Canadian regulators report several MDAP accomplishments and updates over the course of last year:
Authorization of 545 devices to treat or target COVID-19 infections;
Authorization of 18 clinical trials for devices to treat COVID-19 infections;
Medical Device License (MDL) authorizations for 332 high-risk Class III and IV devices;
Approval of 122 new investigational testing applications for medical devices;
Approval of 2,693 requests for special access to devices.
In addition, Health Canada established a Medical Devices Directorate or MDD in early 2020 that combines both pre- and post-market functions in a single office to better oversee Canada’s device market from a lifecycle perspective.
Pillar 1 progress
Under Pillar 1 of the MDAP, Health Canada reports that an initial plan for modernizing clinical trial regulations as well as a public consultation have been rolled out, to be followed by draft regulations in 2022.
Also, Health Canada has established regularly recurring meetings of the Scientific Advisory Committee on Health Products for Women, which will continue through 2021. The regulator also expects to publish draft guidance for clinical evidence requirements in summer 2021.
Pillar 2 progress
For Pillar 2 of the MDAP, Health Canada issued final regulations on a mandatory reporting regimen, the Canadian Medical Devices Sentinel Network, for hospitals regarding medical device incidents, and also launched an online education system for hospitals and other healthcare providers; in 2020, some 3,500 incidents involving medical devices were submitted to Health Canada using this new system. The regulator plans additional outreach to long-term care providers and private clinics to boost participation in the network.
Separately, Canadian regulators issued final regulations on post-market surveillance of medical devices in December 2020, and published an initial report on use of real-world evidence for regulatory development.
Third, Health Canada reports hiring additional inspectors and analysts, as well as stepping up foreign inspection activities through early 2020, before the coronavirus pandemic began.
Pillar 3 progress
Finally, Health Canada’s progress under Pillar 3 of the MDAP includes the following developments:
Publishing final regulations on clinical information;
Launching a searchable public web portal for drug and medical device data;
Publishing a searchable webpage for medical device incidents going back to 1978;
Issuing regulatory decision summaries for medical devices.
Next steps for MDAP
Near-term plans by Health Canada to further advance the MDAP include a focus on what the regulator calls the Advanced Therapeutic Products Pathway, which involves authorization of cutting-edge and innovative products that do not align neatly with the agency’s existing regulatory framework. This new pathway is intended to allow tailored requirements for new pharmaceuticals and medical devices such as healthcare products utilizing artificial intelligence (AI). Health Canada plans consultations with stakeholders regarding pathway design and implementation later in 2021.
Canadian regulators are also pursuing Agile Licensing for Medical Devices, which would mean more flexible regulations to better accommodate and oversee device lifecycles. This effort may include more reliance on decisions and policies developed by foreign regulators to expand treatment options and access to devices by Canadian patients and caregivers. Health Canada consultations with stakeholders will continue into 2022 for its agile licensing proposal.