During the end of 2018, there have been many stories and headlines about Canada’s lack of proper regulations for all medical devices. It has been pointed out that the regulations were outdated and not according to the current standards, especially considering the fact that medical equipment has changed a lot in the past ten years.
The main areas that are lacking in Health Canada’s regulation include poor development of event monitoring systems and adverse approval of medical devices. Due to these stories and the obvious lack in regulation, Health Canada has already stated at the beginning of 2019 that they will look into the matter.
There is already a process in motion now and Health Canada has taken steps to improve medical device regulation.
Regulation Gaps
Some of the largest media outlets in Canada have been working as a part of a large international research team on medical device regulation and they focused their work on issues Health Canada has. They have noticed three major gaps that needed to be addressed as soon as possible:
- All of the medical implants that patients receive don’t have to be tested on living humans, just cadavers or animals.
- When medical devices were used in Canada, health clinics and hospitals had no obligation to perform recalls, updates, or alerts. Only importers or manufacturers had to do this, which led to slow responses.
- Many of the medical devices that were withdrawn from other markets weren’t checked or removed from patients in Canada and remained in use without any investigation.
The report also revealed that Canadian patents have limited information about the devices that were given to them. Most importantly, the investigation showed that poor patient registry led to patients having very little recall information about medical devices and that products like cars had more transparent information.
New Goals for Health Canada
Soon after the investigation was made public, the current Minister of Health announced that Health Canada outlined 3 goals which will be pursued in the future towards improving these regulation gaps.
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An improved process of medical device approvals
All medical devices need to be pre-approved before entering the market. This is why all the policies that govern this process need to be reviewed and changed. Additionally, products will have to meet higher scientific requirements and they will need to come with reliable clinical data that can be assessed.
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Improved surveillance of medical devices currently on the market
Health Canada has also promised that they will take actions to encourage reports of incidents, malfunctions, or issues with medical devices currently on the market. They will not only help health professionals, the industry, and the patients be able to submit reports, but they have promised to set new rules that will force companies to submit reports when warnings have been issued by foreign regulators.
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Establishing a more transparent medical device approval system
When complex medical devices are approved, Health Canada will establish a system where they will provide all the regulatory decisions in a transparent manner. Additionally, all the clinical data which will be required for a device to be put on the market will also be available to the public and all health institutions and patients will be able to see them.
Health Canada’s action plan
As a response to their promise of 3 final goals, Health Canada has published its action plan of 3 steps that will help improve the regulation of medical devices. This plan was released at the end of 2018 and it is already in motion. The goal is to continuously work on improving the quality, effectiveness, and safety of medical devices and the regulatory processes.
Step 1: Improved process of delivering devices on the market
By allowing medical researchers and health professionals to file a formal application to get authorization for conducting tests, Health Canada will help increase and improve research methodology. At the moment, only industry manufacturers can do this and since they are biased, having independent healthcare experts and researches will promote better, more thorough research.
Canadian Institute of Health Research along with Health Canada will together form a committee that will work on health issues caused by drugs, as well as medical devices. They will also work on reviewing requirements for medical devices with high risk and implement measures that will require hard evidence for device authorization.
Step 2: Improved monitoring with better follow-ups
With the proposed Vanessa’s Law, it is expected that new rules will be set in place to create more rigorous regulation of medical products and enhance the level of reporting of all healthcare organizations. These new measures will allow Health Canada to become better at collecting safety information about products that are already on the market.
The same processes will be implemented for hospitals so that they can report when patients have adverse reactions to device-related incidents and drugs that they were taking.
Step 3: More information transparency and accessibility
Health Canada’s third step is working on creating brand new regulations that will allow the public to see all the important clinical trial data that is provided when new medical devices are brought to the market, but also for the current ones.
Health Canada will also release all the information concerning their approvals of license applications for all medical devices, not just a certain type as it was customary until now. This means that all patients and health professionals will be able to see this information at any time and see the logic behind their approvals.
The whole process is expected to last several years, as there are major regulatory and law changes that need to happen. At the same time, it will require both the industry and the government to put in the effort to make the desired improvements.
