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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
- Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the …
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 …
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 …
Medical Devices Regulations ( SOR /98-282) - laws …
- https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html
- 6 Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV …
About medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html
- In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the …
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 system …
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