Health Canada Medical Device Regulations

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

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

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision. 43.2 - Application. 43.3 - …

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, diagnosis …

Legislation and Guidelines - Medical devices - Canada.ca

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

Go to the Justice Canada Web site. Type Medical Devices Regulations in the Title field. In the yellow box beside Search in , select Regulations, then select Search. Select Canada …

Guidance documents – Medical devices - Canada.ca

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

Draft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28] Implementation of Advance Notice of Importation Process for …

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

The purpose of the Medical Devices Regulations is to help protect the health and safety of Canadians with respect to the sale of medical devices. The term 'medical device' covers …

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 …

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

For more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

About medical devices - Canada.ca

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

Types of medical devices. Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and …

Guidance on summary reports and issue …

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

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new …

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