Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity is necessary to ensure safety and effectiveness of devices intended for human use. This article provides a general overview of the current medical device regulations in Canada.
The institution responsible for regulating medical devices in Canada is the Medical Devices Bureau (MDB) of the Therapeutic Products Directorate (TPD), a federal authority within Health Canada. TPD uses a Canadian Risk-Based Classification System (RBCS) to classify medical devices. Similarly to the European Union, Canada classifies devices under four different classes. This is unlike the US FDA’s method, which groups medical devices into one of three classes.
Just like in most countries in the world, in Canada manufacturers are required to maintain data on their medical devices, identify potential risks associated with use of the device, and ensure the safety and effectiveness of the devices. Below are the most important aspects of the current medical device regulations in Canada. All topics have been thoroughly covered in Medical Devices Regulations (SOR/98-282).
1) Classification of Medical Devices
Class I devices are associated with the lowest risk, while class III and IV devices are associated with the highest risk. While class I devices do not require the manufacturer to hold a license for distribution within Canada, all devices of Class II and above require the possession of such license.
The Medical Devices Bureau maintains a database of all licensed medical devices in Canada. Only products present in the database can be distributed within Canada, with exception of Class I medical devices, which are monitored by the Health Products and Food Branch Inspectorate and can be marketed without a licence. If it is possible to classify certain device under more than one class, the higher class applies.
2) Quality Management Systems
It is required that all medical devices marketed in Canada are compliant with Canadian National Standard CAN/CSA ISO 13485:03. This is used as evidence of compliance to regulatory quality management system requirements and can only be issued by Health Canada-recognized, third-party auditing organizations. Quality system regulations apply to Class II, Class III, and Class IV devices. For Class I devices, there are no regulatory quality management system requirements.
Health Canada has published a list of organizations that are eligible to authorize quality management certificates for CAN/CSA ISO 13485:2003.
3) Distribution records
Manufacturers, importers, and distributors of medical devices must maintain distribution records for every device marketed in Canada. This rule does not apply to retailers and healthcare facilities through which devices are distributed. Distribution records must contain sufficient information to permit complete and rapid withdrawal of the medical device from the market if necessary. All distribution records shall be kept for at least two years from the date when the device was shipped or for the duration of the projected useful life of the device, depending on which period is longer.
The distribution records issue has been thoroughly explained in Sections 52 through 56 of SOR/98-282.
4) Complaint handling, recalls and mandatory problem reporting
Manufacturers, importers, and distributors must maintain records of any issues with the performance or safety of the device, including consumer complaints. In the case that the device seriously injures or leads to the death of a patient, both the manufacturer and the importer must submit a preliminary and final report to Health Canada.
The preliminary report must contain the following information:
- Name of the device, its identifier number, and the contact information of the manufacturer or importer;
- Data regarding the negative effect of the medical device on patient’s health, date on which the incident happened, and the reason for recall (if applicable);
- Preliminary comments of the manufacturer or importer regarding the incident.
After the preliminary report, the manufacturer and importer must submit a final report, which must include the following information:
- Detailed description of the incident;
- Explanation of the cause of the incident and justification for actions taken as a result of the incident;
- Report on any actions taken as result of the investigation.
If a recall is required, both the manufacturer and the importer must report to Health Canada before or during recall processing and after the completion of the recall and must provide the results and actions taken to prevent the recurrence of the problem. Detailed information regarding the topic discussed above may be found in Sections 57 through 65 of SOR/982-282.
A medical device cannot be sold in Canada unless its label contains the following information:
- The name of the device, its identifier, its control number (only for class III and IV devices), and the address of the manufacturer;
- The expiry date of the device (if applicable);
- Explanation of what the package contains (if applicable);
- Guidelines for use and storage of the device
Label must be prepared in both of the official languages in Canada: English and French. If a device is going to be obtained by general public, information must be visible and placed on the packaging. Detailed regulations towards labelling may be found in Sections 21 through 23 of SOR/982-282.
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