Author: Karen Zhou
In a sweeping move to strengthen the safety, effectiveness and quality of medical devices, Health Canada has rolled out a three part Medical Device Action Plan for 2019. The project is consistent with the agency’s commitment to transparency and will continue to develop regulations under Vanessa’s Law, which provides the legal framework requiring hospitals to increase incident reporting. Integrated in the pre-market and post-market aspects of the strategy are transparency initiatives with the aim of making regulatory decisions and manufacturers’ information such as clinical data and incident reports more accessible to the public. The tripartite strategy is as follows:
I. Improving how devices get on the Canadian market;
II. Strengthening post-market follow-up;
III. Providing transparency about the medical devices on the Canadian market.
Throughout 2019, Health Canada will continue to engage and update the Canadian public in the implementation of the Action Plan.
Part I – Improving How Devices Get on The Market
· Investigational testing regulatory changes – Proposed changes to the investigational testing regulatory framework will allow healthcare professionals and independent researchers, in addition to manufacturers, to file an application for authorization to conduct clinical studies of unlicensed devices. Changes will also provide more oversight requirements including safeguards for clinical study participants.
· Expanding scientific expertise – To continue ensuring access to independent scientific opinions, Health Canada will engage external experts to form a scientific advisory committee on women’s health issues for drugs and medical devices (On January 30, a call for nominations was released. See reference 3). This new committee is in addition to the two existing committees on digital health and cardiovascular devices.
· Reviewing evidence requirements for high risk devices – It is Health Canada’s intention to revisit the clinical evidence requirements related to higher-risk devices based on previously authorized versions.
Part II – Strengthening Post-Market Follow-Up
· Vanessa’s Law and mandatory reporting for healthcare facilities – The current medical device regulatory framework requires both manufacturers and importers to report medical device incidents. Under Vanessa’s Law and its developing regulations, hospitals will also be required to report incidents. To this end, Health Canada is working on an education plan to help hospitals and healthcare professionals identify and report medical device incidents. An increased number of incident reports will improve surveillance capabilities and signal detection.
In addition to hospitals, Health Canada also plans to improve incident reporting from other types of healthcare facilities such as private clinics and long-term care facilities. To this end, new facilities will be added to the current Canadian Medical Devices Sentinel Network (CMDSNet), which is an initiative since 2009 to support incident reporting from healthcare facilities. To encourage reporting, Health Canada is currently working on an education and promotion program aimed at healthcare facilities other than hospitals to help them identify and report incidents. However, if education fails to sufficiently increase reporting frequency, Health Canada may consider additional regulations aimed at mandatory reporting.
· Vanessa’s Law and information on safety and effectiveness – With Vanessa’s Law, Health Canada will also have the authority to compel manufacturers to conduct assessments, tests and studies in response to a study, a warning or any other relevant information that may originate in other parts of the world. Health Canada can also compel manufacturers to provide information regarding label change or licence suspensions.
· Use of real-world evidence – Health Canada also intends to use real-world evidence to monitor the safety and effectiveness of a device. A framework is currently being developed for the use of real-world evidence across the product life cycle.
· Enhanced capacity in compliance and enforcement – Health Canada will continue to invest in areas of inspection and compliance including onsite foreign inspections. Additionally, there will be enhanced efforts to promote the compliance of manufacturers, importers, distributors and healthcare professionals with mandatory reporting requirements.
Part III – Improving Access to Information
· New regulations to improve access to clinical information – To improve access to clinical study data provided in submissions, Health Canada plans to implement regulations that will allow the release of clinical information. It is Health Canada’s view that increased access to data will provide additional clinical insights to the benefit of patients.
· Increasing information on device approvals – Health Canada also intends to publish regulatory summaries of both Class III and Class IV approvals and their amendments. This increases transparency of the regulatory decision-making process to the Canadian public. In a recent notice, the agency announced that Regulatory Decision Summaries (RDS) for new Class III devices will be posted starting January 31 (see reference 2).
· Increasing access to incident reports and inspection results – A general database containing individual incident reports will also be launched to improve access to post-market information. Additionally, the medical device inspection database will also be improved to facilitate access to inspection results.
Timelines
| Target Date | Activity |
Part I Improving How Devices Get on The Market
| January 2019 | Call for members for the new Expert Advisory Committee on Women’s Health (reference 3) |
| March and May 2019 | Meeting of Scientific Advisory Committees |
| June 2019 | Notice of Intent on changes in investigational testing |
| September 2019 | Publication of What We Heard Report based on changes announced in June on investigational testing |
| November 2019 | Draft guidance document on evidence requirements |
Part II Strengthening Post-Market Follow-Up
| March 2019 | Hiring of an additional 8 inspectors and 2 investigational analysts |
| April 2019 | Increase in the number of foreign inspections from 80 to 95 |
|
June 2019 |
· Publication of regulations to report medical device incidents · Expansion of CMDSNet · Publication of draft regulations to require manufacturers to provide a great scope of information Establish how real-world evidence for regulatory decision-making will be used |
| September 2019 | Launch of education program for other healthcare settings |
| November 2019 | Increase in compliance promotion activities |
Part III Improving Access to Information
| January 2019 |
· Publishing and regularly updating a de-personalized data extract file of medical device incidents, complaints and recalls Launch of publishing of more Regulatory Decision Summaries (RDS) (reference 2) |
| June 2019 |
· Publication of regulations to release clinical information on medical devices Launch of a searchable public web portal following publication of above regulations |
| December 2019 | Publishing a searchable medical device incident database |
References
1. Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality
2. Notice: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options
3. Scientific Advisory Committee on Health Products for Women (SAC-HPW): Nomination Call for Members
4. Health Canada proposes new regulations linked to Vanessa’s Law to further strengthen the safety and surveillance of drugs and medical devices https://www.canada.ca/en/health-canada/news/2018/06/health-canada-proposes-new-regulations-linked-to-vanessas-law-to-further-strengthen-the-safety-and-surveillance-of-drugs-and-medical-devices.html
5. Canadian Medical Devices Sentinel Network