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Quality Systems ISO 13485 - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485.html
- The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I …
Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
- The Department is pleased to announce that it will begin publishing Regulatory Decision Summaries (RDSs) for amendments to Class III and IV medical …
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 …
What is the relationship between FDA's Quality …
- https://www.fda.gov/media/75903/download
- FDA's Quality System Regulation Part 820, is harmonized with ISO 13485:1996,which is based on ISO 9001:1994. ISO 13485:1996 contains requirements formedical device …
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