Medical Device Regulation Health Canada

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Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - Manufacturer’s Obligations; 10 - Safety and Effectiveness Requirements; 21 - Labelling Requirements; 24 …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, …

Legislation and Guidelines - Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html

The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

About medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html

Frequently Asked Questions - Medical Devices Regulations

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class IV …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in …

What's new: Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Consult the Drug and Health Product Register regularly for Regulatory Decision Summaries for medical devices. Consult the Drug and Health Product Register regularly for Post …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

Devices can be grouped into 1 of 4 types as defined in the Regulations: medical device family; medical device group; medical device group family or ; medical device …

Guidance Document: Software as a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html

The Medical Devices Regulations (the Regulations) have been established under the authority of the Food and Drugs Act (the Act) and apply to all medical devices imported or sold in …

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