In 2014, amendments to the Food and Drugs Act gave the federal Minister of Health authority with respect to the safety of drugs, medical devices and other therapeutic devices that are already on the market. The specific powers conferred by the amendment included the ability to compel further studies, testing and cost-benefit assessments. Changes to the regulations relating specifically to drugs were implemented in 2018 and, as discussed in this update, Health Canada is now partway through a consultation process with respect to regulatory changes that will be needed to fully implement the 2014 amendments with respect to medical devices.
On June 14, 2019, Health Canada launched a new phase of the medical device consultation process in which the general public is invited to comment on the proposed regulations. This latest step in the process, considered in detail below, follows an industry-focused costing survey that was sent in January of this year to members of each of the following key stakeholder groups: medical device licence holders (“MDLHs”), establishment licence holders for importation, Class I medical device manufacturers and industry associations.
The deadline for comments on the current public consultation phase is August 26, 2019. The text of the proposed amendments is available in the June 15, 2019 Canada Gazette, following the Regulatory Impact Analysis Statement.
Goals of Health Canada’s Proposed Amendments
Health Canada’s proposed amendments are focused primarily on three substantive objectives:
1. Clarifying certain details of how the Food and Drugs Act provisions are to be operationalized
One purpose of Health Canada’s proposed regulatory changes is to fill in some of the details about process that are necessary to make the 2014 Food and Drugs Act amendments workable, notably with respect to the Minister of Health’s authority to order MDLHs of Class II, III and IV medical devices to conduct assessments, additional tests and studies, to monitor experiences, and/or to collect information about devices after they have gone on the market.
In addition, the amended regulations will harmonize the regulatory provisions concerning therapeutic drugs and therapeutic medical devices as they relate to tests and assessments.
2. Improving the reporting of foreign incidents and regulatory actions
Currently, incidents that occur outside Canada are required to reported to Health Canada only if the regulatory agency of the country in which the incident occurred has required the manufacturer to take corrective action or the manufacturer advised that regulatory agency that it intends to do so.
In Health Canada’s view, this process is inadequate for a variety of reasons. For example, there is no set time-frame for such a report, nor is there any requirement to identify the corrective actions taken in response to the incident. The proposed amendments will accordingly require MDLHs and importers of Class II, III and IV medical devices to advise Health Canada within 72 hours, in the event that they or certain foreign regulators take any of the following actions with respect to a “serious risk” related to a medical device that is marketed in Canada:
- Communicate the risks related to the medical device;
- Change the labels on the medical device;
- Begin a product recall process;
- Begin a reassessment; and
- Suspend or revoke a medical device licence.
The list of foreign jurisdictions would be limited to members of the International Medical Device Regulators Forum or other countries with which Health Canada has a mutual recognition agreement or similar memorandum of understanding in this area. According to Health Canada, fewer than 20 jurisdictions currently meet those standards.
3. Making post-market surveillance more effective
Health Canada is proposing two additional regulatory changes that are intended to improve its ability to conduct post-market surveillance of medical devices.
Through annual summary reports
These regulatory changes will require MDLHs of Class II, III and IV medical devices to prepare an annual report detailing whether (i) there has been a decrease in any of the benefits of the device; (ii) the risks are more likely to occur; (iii) the consequences for patients or users may be more serious, if a risk occurs; or (iv) any new risks have been identified. Where the MDLH finds that there has been such a change in the risks or benefits of the medical device, the proposed regulations will require the MDLH to notify Health Canada in writing within 72 hours.
Through issue-related analysis of safety and effectiveness
The proposed regulation seeks to empower the Minister of Health with the ability to order manufacturers of Class I devices and MDLHs of Class II, III and IV medical devices to prepare an analysis on an issue related to the safety and effectiveness of a device. Such orders will be issued where the Minister requires an analysis in order to complete a post-market review of the safety and effectiveness of a medical device in response to a signal regarding the device. Although there is no current guidance on the form of this “analysis”, Health Canada has advised that it will provide details in due course and expects that it will require an analysis of device incidents, exposure data, the manufacturer’s conclusions regarding the safety and effectiveness of the device, and a risk mitigation strategy, if necessary.
The proposed regulation also contemplates that the Minister will have the authority to suspend the MDLH’s licence or to order a stop sale of Class I devices in the event that the MDLH fails to prepare the analysis when ordered to do so.
Additional Changes
Finally, the new regulations will ensure that medical devices will automatically be required to comply with the latest ISO standard as soon as it becomes official. Essentially what this means is that it will no longer be necessary to amend the name of the relevant ISO standard in the regulations. Health Canada is taking this approach in order to eliminate the existing lag-time after ISO standards change, ensuring that Canadian requirements are always in line with those of other major jurisdictions.
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