Regulations Medical Devices Canada

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 - …

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

How to find the Medical Devices Regulations : Go to the Justice Canada Web site. Type Medical Devices Regulations in the Title field. In the yellow box beside Search in , …

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 …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Anyone who imports a medical device into Canada must also meet all applicable requirements of the FDA and associated Regulations. Some requirements include the …

Standards - Canada.ca

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

Standards - Canada.ca Standards The following are links to the list of national and international medical device standards recognized by the Therapeutic …

Guidance Document: Guidance for the Labelling of …

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

Section 21 (1) (i) - The directions for use, unless directions for use are not required, (i) in the case of decorative contact lenses, for the device to be used safely, …

List of Recognized Standards for Medical Devices

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

Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement. ISO 14708-1:2014-Ed.2.0. …