Medical Device Services for Canada
The term ‘Medical Device’ is used to refer to any apparatus or equipment designed to be used in the diagnosis or treatment of human patients. These devices can include software, surgical tools, machinery and even gloves.
Canada Medical Device Regulations
Requirements for Medical Devices in Canada are some of the strictest in the world. All Medical Devices are reviewed by Health Canada before authorization for their sale in Canada is granted.
Regulatory strategic planning and product classification
The first step towards authorization of Medical Devices in Canada is classification based on their level of risk. Class I devices do not require a license. However, producers of these devices require an Establishment License. Cosmereg can help your business to determine which category your medical devices fit into, and support you in applying for the appropriate license.
Organize and manage meeting with the Therapeutic Products Directorate (TPD)
Medical Devices are regulated by the Therapeutic Products Directorate (TPD). Cosmereg can assist your company by organizing and managing meetings with the TPD, for pre-market approval of Medical Devices.
Prepare and file CTA’s (Clinical Trial Applications)
In order to market a Medical Device in Canada for use in a Medical Trial, a Clinical Trial Application (CTA) must first be submitted, just as in pharmaceutical trials. Cosmereg can assist your company with this application process.
Prepare and file Class II, III and IV applications
Class II, III and IV medical devices require a license to be sold in Canada. In order to obtain a license, a Medical Device License Application must be submitted to the TPD. The amount of information required for this application varies according to the device. Cosmereg provides a full Medical Device License Application service.
Provide application support during TPD review
Sometimes, applications are not immediately approved by the TPD – this may be due to a lack of information included in the application documents. Manufacturers of Medical Devices have the right to appeal decisions and re-submit their applications. Cosmereg can assist your business in ensuring that all the required information is included in your application, before it is reviewed by the TPD.
Perform Quality System audits
Manufacturers of Medical Devices must submit a Quality System Certificate to Health Canada. This is to prove that the device complies with industry regulations for its manufacture. Audits of product manufacture and quality are an essential component in ensuring that Medical Devices meet Health Canada standards. Cosmereg can assist your business in designing and conducting these audits.
Provide label and advertising review
Just as with food products or cosmetics, Health Canada stipulates that Medical Devices must be appropriately labelled. Medical Devices must not be sold or advertised in a manner that is misleading to the public. Cosmereg can assist your company to ensure that labels and promotional materials comply with Health Canada regulations.
Resolve regulatory compliance issues
Compliance with Canadian Medical Device regulations can sometimes be a complicated process. Cosmereg provides a full service for regulatory compliance and can assist your business in every step of the process.
My device has FDA clearance – is there a fast-track for devices sold in other major markets?
Health Canada does not recognize approvals granted outside of Canada. Having prior approval in another country (such as FDA approval in the US) does not provide any advantage in the Canadian approval process. However, if your application has previously been rejected in another country, this may adversely affect its chances of approval in Canada.
A lot of the information required for Health Canada submissions is very similar to that of an EU technical file or US 510(k), so already having completed these could reduce the time needed to prepare for submission.
Do foreign manufacturers need local representation in Canada?
No. Health Canada does not require foreign manufacturers to have local representation in order to register and sell medical devices. Foreign manufacturers are able to submit applications and hold device registrations.
We offer other Canada Services
Cosmereg can assist you with all of Canadian’s cosmetic regulations and requirements, whether you’re manufacturing in Canada or importing products into Canada.
In Canada, Natural Health Products (NHPs) are products such as vitamins and minerals, probiotics and traditional medicines.