If you’re considering expanding your medical supplies business in Canada? Let me tell you; it is pretty challenging to pass through the Canadian regulations to sell your product because they don’t compromise on anything.
There are some similarities found in Canadian medical supplies regulation and the FDA in the United States. But along with the similarities, we can also find apparent differences. So, it is expected from the suppliers to understand the regulations deeply. The Canadian government is quite concerned for their public health & therefore has taken complete responsibility.
Here we’re going to share the significant regulatory differences between Canadian and US medical supplies.
How are Medical Supplies Canada Regulations Different from the States?
The medical supplies Canada regulatory has to be placed in 1998 with the significant regulation standards. It includes:
- Effectiveness for Medical Equipments
- Essential to fulfill the requirement of quality system
- Precise classification in vitro or non-vitro types of equipment
- Safety regulations for pieces of equipment
Classification for Medical Supplies Canada
Food and drug administration has classified the medical supplies into 3 classes. This classification is dependent on the risk level:
Class I: Class I include the medical pieces of equipment with a lower risk factor, i.e., stethoscopes.
Class II: In 2nd class, wheelchairs are include
Class III: In the 3rd class of medical supplies, we can find the devices with higher risk factors.
While according to Canadian health regulation, the medical supplies Canada is divided into four levels/classes. In Canada, Level I do not need any license or application. While if an organization wants to get approval from the government for level III, it should submit valid ISO 13485 certifications. And for level IV, the organization must offer a health Canada license along with ISO 13485 certifications.
Postmarket reporting in Canada for medical supplies in general. But in the States, these postmarket requirements are under the address of the FDA. It includes:
- Device Malfunction Reporting
- Establishment Registration
- Tracking System
Along with these requirements, FDA has required the following from classes II and III.
- Devices Should be Life-Supporting
- Devices Should be Implanted for more than 1 Year
- Should be used in pediatric populations
Health Canada has clearly stated that medical supplies should meet the standards of Canadian Medical Devices Regulations postmarket it simply includes:
- Device Complaint Handling
- Mandatory Problem Reporting
- Distribution Record Maintenance
In States, FDA has provided the list of application fees that are needed for medical supplies approval. It includes pre-market approval fees, post-market authorization, biologics license application, and product development protocol.
While for medical supplies Canada, class I is wholly exempted from the license applications, they do not need any special fees. Health Canada has updated different prices for classes II, III, and IV. These feeses are as follow:
- Class II License application fees are C$414
- Class III License application fees are C$5,922
- Class IV License application fees are C$13,770
Manufacturers have to pay an additional fee according to equipment class and quality control processes.
Medical Supplies Canada Regulations
Although there are many similarities between the regulations of States and Health Canada, these regulations have to be fulfilled by all medical equipment manufacturers and supplies. We all know that the patient market in Canada is smaller than in the United States. Therefore, both markets are structured differently. Similarly, the quality assurance system of both markets is also different, which you need to understand before applying for the license.
Like other countries, Canadian’s also rely on medical pieces of equipment to maintain and health improvements. Therefore, health Canada has supported the supplies and manufacturers during all difficult times. During COVID-19, medical supplies Canada has faced a lot of difficulties. Thus, the government of Canada has taken different steps to ensure the effectiveness and safety of medical equipment that is usually used by Canadians.
Health Canada has developed a complete plan under the supervision of the Minister of Health to strengthen the regulations of medical supplies in factors. Before planning, you have to understand the updates and rules thoroughly. Understanding the rules will help you out in providing the best medical supplies without any issue. You should not forget the Health Canada and Government will not compromise on quality and standards.