In the past few days, there has been increased media attention in Canada and around the world on the safety, efficacy, and regulation of medical implant devices. This focus is on multiple reports of alleged adverse events related to certain medical implant devices, such as replacement hips, vaginal mesh, permanent contraceptives, spinal disc replacements, breast implants, pacemakers, and cardiac defibrillators.
Regulators around the world have been quick to announce plans to address some of the public concerns arising out of the international attention to these products. On November 26, 2018, the U.S. Food and Drug Administration unveiled its plans to update the regulatory review of certain medical devices sold and marketed in the United States1. On November 29, 2018, the Canadian Federal Minister of Health announced that Health Canada would focus on strengthening pre-market approvals and post-market surveillance of medical devices, and recognizing the need for increased transparency.2 The key anticipated changes by Health Canada include:
- Review of the policies and scientific requirements for the approval of higher-risk medical devices. Presumably, this may suggest that a higher level of scientific evidence on safety and efficacy data would be required to be submitted by manufacturers for the purpose of obtaining a medical device license. There is some suggestion that this may include a requirement for clinical data for high-risk medical devices. It is not clear however to what extent, if any, manufacturers will be required to rely on older versions of their devices in support of the safety and efficacy of their new products for the purpose of pre-market approval. The U.S. regulator made it clear that they would like to discourage reliance on comparisons from devices that have been on the market for more than a decade. As well, the U.S. regulator suggested that its updated regulatory approval scheme would address the increased interconnectivity and interoperability of emerging medical devices, including the related cybersecurity concerns. It is not clear to what extent Health Canada’s already underway review of digital health technologies may inform the pre-market approval process of medical devices in terms of concerns around cybersecurity, medical device interoperability, and wireless medical devices3.
- New rules requiring prompt disclosure to Health Canada when foreign regulators issue warnings about a device. It is noteworthy that Health Canada announced in the Spring of 2018 its intention to propose changes to the post-market surveillance and risk management of medical devices in Canada4. Some of these proposed changes to the current regulatory framework included: providing the Minister of Health with the authority to request analytical issue reports and back-up information from a manufacturer when there is a suspicion of a safety concern, along with the ability to compel manufacturers to provide annual reports and notify Health Canada of disclosures made to regulatory bodies in other jurisdictions. The types of noted disclosures included "any risk communications, changes to labelling, recalls, reassessments, and suspensions, or revocations of medical devices occurring in other countries"5. At the time, there was some suggestion of anticipated regulations being rolled out in early 2019.
- Improve reporting of medical device incidents by industry, health professionals, and Canadians and make such reports publicly available. Under the current regulatory regime only the manufacturer and importer of the device are required to report certain device-related adverse events and product problems to Health Canada. It appears, however, that the mandatory reporting scheme may be expanded to include other parties. In the U.S., mandatory reporters include not only manufacturers and importers, but also device user facilities, with voluntary reporting by health care practitioners, patients, and consumers as well.
- Increased transparency with Canadians to provide them with additional information about the use of medical devices, including providing summaries of regulatory decisions of Class III and Class IV device approvals and access to clinical data supporting Health Canada’s authorizations. Health Canada has been considering an increase in transparency around its decision making and regulatory activities since at least October 20066. It remains to be seen how this identified priority is implemented by the regulator in this iteration.
It appears that the medical device industry likely stands to witness a significant change in the regulatory oversight of medical devices not only in Canada, but internationally. For the time being, however, manufacturers, distributors, and vendors of medical devices may wish to strengthen their own internal compliance and reporting systems so to be better equipped to operate in a changing regulatory landscape.
1Statement from FDA Commissioner Scott Gotlieb and Jeff Shuren on Transformative New Steps to Modernize FDA’s 510 (k) Program to Advance the Review of the Safety and Effectiveness of Medical Devices, November 26, 2018.
2 Statement from the Minister of Health on the Regulation of Medical Devices in Canada, November 29, 2018.
3 Health Canada, "Notice: Health Canada’s Approach to Digital Health Technologies," April 10, 2018.
4 Health Canada, "Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada," April 10, 2018.
6 Health Canada, "Blueprint for Renewal: Transforming Canada’s Approach to Regulating Health Products and Food," October 2006.