Health Canada Regulations For Medical Devices

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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 - …

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

Guidance documents – Medical devices - Canada.ca

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

Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices, and the …

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

What are the key elements of this regulation? Classification Rules for Medical Devices. The Medical Devices Regulations include rules to help classify devices into... Safety …

Standards - Canada.ca

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

Standards. The following are links to the list of national and international medical device standards recognized by the Therapeutic Products Directorate (TPD) …

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 …

Guidance Document: Recognition and Use of Standards …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-recognition-use-standards-under-medical-devices-regulations.html

a medical device licence for a Class II, III, or IV device (Section 32 of the Regulations) and if applicable, a medical device licence amendment; an authorization for special …

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