The use of medical products in healthcare institutions is important, but do you know exactly how they are used and why it would be better to use Canadian medical products?
When we talk about medical equipment, we are referring to all the instruments used by medical professionals to perform their duties. From work clothes to machines, tools and prostheses.
These different medical products must pass a series of tests and comply with established regulations before coming into contact with the patient and even after being used they must remain under supervision.
In this article we will explain how the Canadian medical supplies market works and what are the sanitary protocols for the use of medical equipment that health institutions must follow.
Clinical Supplies Market in Canada
According to the U.S. International Trade Administration, the Canadian market for medical instruments is very well developed. In fact, imports of medical equipment account for 75% of this market.
However, with 44% of total imports, thanks to geographic proximity and similarities in safety and quality standards, the United States is Canada’s main supplier of medical products, followed by China, Mexico and Germany.
The reason for this disparity is presumably due to the fact that the Canadian market is dominated by SMEs and much of the industry is based in the three main provinces, Ontario, Quebec and British Columbia.
A smart industry
Medical devices companies in Canada work in such a way that they can count on constant evolution and discovery of their products.
Medical technology consortia spend 11% of their revenues on R&D each year, while SMEs spend approximately 343% of their revenues on R&D.
How do you sustain economic growth?
For new and small medical device companies, stable and sustained funding during the early stages of prototype and product development can become an impossible barrier to successfully overcome.
Typically, many Canadian medical supply companies are appendages of university laboratories or other companies.
These SMEs often have liquidity problems for research and development of new technologies in their first years in the market.
Therefore, they end up relying, to a large extent, on partnerships with other institutions to research, develop and validate the status of their discoveries.
Sanitary protocols for the use of medical devices in Canada
Once medical products in Canada have been developed, they must be classified before going to market. As you may recall, we mentioned in the previous point that safety and quality standards in Canada are very similar to those in the United States.
The only difference, in this part, that you will find, is that Americans have three rating levels while Canadians have four.
Classification of risk levels
On Canadian territory, medical instruments are regulated by the Food and Drugs Act and are classified into four divisions, based on risk levels.
When a medical supply falls into the Class I category, it means that this product represents minimal harm to the patient and is composed of a very basic design.
This type of device would represent a medium risk. That is, they are on the borderline between invasive and non-invasive. For example: injectors, MRI with contrast, surgical gloves.
These devices are life-sustaining, implanted, or present a potential risk of disease or injury to the patient. They are usually hip implants, glucose monitors, or surgically invasive devices.
Very high-risk clinical supplies such as pacemakers and surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system.
How to classify
Under current law, Canadian manufacturers or medical suppliers are responsible for classifying the device.
In the following we will discuss the problems that have arisen with these rules and how work has been done to change them.
Why choose Canadian medical products?
Wrapping up 2018, a number of international press articles drew attention regarding certain loopholes in the various medical products in Canada. Some of these loopholes were:
- Testing on animals or cadavers.
- Use of recalled devices out of circulation, without informed consent.
- Independence of the manufacturer to report the latest updates.
These problems led many Canadians to use dangerous products without being aware of it, while exonerating companies from liability.
Health Canada’s response
In December of the same year, Health Canada published an action plan to make the medical device approval and oversight system more transparent with citizens. The plan consists of the following points:
Part I: Improve the way devices reach the market.
Increase practitioner vetting to improve patient protection. The proposed changes will allow healthcare professionals to submit an application for authorization to test medical devices in Canada.
Part II: Strengthening monitoring and follow-up
- Implement mandatory reporting and expand the Canadian Medical Device Sentinel Network.
- Establish capacity to obtain information on the safety and efficacy of medical devices and expand the use of real-world evidence.
- Improve inspection and enforcement capacity.
Part III: Providing Canadians with more information.
- Improve access to clinical data on medical devices.
- Increase information on device approvals and publish medical device incident data.
- In late 2019, Health Canada began publishing regulatory decision summaries for Class III medical device licenses.
- Health Canada together with the Scientific Advisory Committee on Medical Devices have succeeded in improving the review process for medical devices used in the cardiovascular system.
- The SAC-HPW provides advice on emerging issues related to women’s health and the regulation of medical devices and drugs.
Based on what we have presented to you in this reading, you can see how the government and hospital products industry in Canada is up to date and even ahead of many other countries.
Right now is the ideal time for you to consider looking for new medical device distributors in Canada to better serve your patients.
At Divocco Medical, our primary goal is to efficiently supply and deliver vital personal protective equipment to businesses in Canada and around the world.
Tomorrow, we will leverage our market position to contribute to I + D and provide AI-based medical technology in clinical settings. Meet the team and you will be convinced.