Medical Device Directive Canada

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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 or prevention of a disease or abnormal physical condition.. Additional information on how …

Medical Devices Directorate – Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

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 …

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 …

Directives, Guidance Documents and Policies - canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies.html

Directives. Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004) Guidance Documents. Draft guidance …

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 …

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 …

Medical device licensing - Canada.ca

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

Medical device licensing. Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing …

Medical Devices Active Licence Listing (MDALL)

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

The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

Canadian Medical Device Regulations: CMDR - ISO 13485 …

http://13485store.com/wp-content/uploads/2016/08/Canada-Medical-Devices-Regulations.pdf

Canadian Medical Device Regulations: CMDR Current as of February 21, 2006 Medical Devices Regulations Current as of February 21, 2006 SOR/98-282 FOOD AND DRUGS …

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