Health Canada Medical Device Regulations Sor

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(9 days ago) WEB43.1 - 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 - …

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

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(6 days ago) WEBSOR/2021-199, s. 7. 62.31 (1) The provisions of these Regulations — other than this section and sections 44 to 62.2, and 62.32 to 65.1 — do not apply to the sale of …

https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html

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Medical devices - Canada.ca

(Just Now) WEBThe 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 …

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

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Guidance on Medical Device Compliance and Enforcement (GUI …

(2 days ago) WEB7.0 Associated Documents. 8.0 Appendix A. 1. Purpose. The purpose of this document is to provide the medical device industry with a clear description of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-enforcement-0073.html

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Medical Devices Regulations ( SOR /98-282) - lois-laws.justice.gc.ca

(1 days ago) WEBGeneral. 80 (1) Subject to subsections (2) and (3), no person shall import or sell a medical device for investigational testing. (2) A manufacturer or importer of a Class II, III or IV …

https://lois-laws.justice.gc.ca/eng/regulations/sor-98-282/page-10.html

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(5 days ago) WEBNon-application of Part 1 — Importation and Sale. 68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a medical device if the manufacturer …

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-7.html

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Canada Gazette, Part 2, Volume 154, Number 26: Regulations …

(2 days ago) WEBCanada's medical device sector is export-oriented, often bypassing the domestic market due to the stringent regulatory structures and relatively small market …

https://gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(5 days ago) WEBIssuance. 68.12 The Minister shall issue an authorization for a medical device if the following requirements are met: (a) the manufacturer has submitted an application to the …

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-8.html

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Canada Gazette – Regulations Amending the Medical Devices …

(2 days ago) WEB1. (1) The definition “safety and effectiveness requirements” in section 1 of the Medical Devices Regulations (see footnote 1) is repealed. (2) Section 1 of the …

https://gazette.gc.ca/rp-pr/p2/2015/2015-07-29/html/sor-dors193-eng.html

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(5 days ago) WEB62.31 (1) The provisions of these Regulations — other than this section and sections 44 to 62.2, and 62.32 to 65.1 — do not apply to the sale of a designated medical device that is …

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-6.html

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Frequently Asked Questions - Medical Devices Regulations

(8 days ago) WEBThe 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 …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

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SOR/98-282 Medical Devices Regulations CanLII

(2 days ago) WEBMedical Devices Regulations. SOR/98-282. FOOD AND DRUGS ACT. Registration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His …

https://www.canlii.org/en/ca/laws/regu/sor-98-282/latest/sor-98-282.html

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(Just Now) WEB2 These Regulations apply to. (a) the sale and advertising for sale of a medical device; and. (b) the importation of a medical device for sale or for use on individuals, other than …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(Just Now) WEB95 (1) A medical device that, on June 30, 1998, is being sold in Canada pursuant to the old regulations is not required to be licensed until February 1, 1999, if, (a) in the case of a …

https://www.laws.justice.gc.ca/eng/regulations/SOR-98-282/page-11.html

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Regulations Amending the Medical Devices Regulations (Medical …

(8 days ago) WEBSOR/2023-277 December 19, 2023. FOOD AND DRUGS ACT. P.C. 2023-1298 December 15, 2023. 2022, for 21 days, informed the development of the COVID-19 Medical …

https://canadagazette.gc.ca/rp-pr/p2/2024/2024-01-03/html/sor-dors277-eng.html

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WASHINGTON, THURSDAY, MAY 2, 2024 No. 76 House of …

(1 days ago) WEBU N Congressional Record U M E P L RI B U S United States of America PROCEEDINGS AND DEBATES OF THE 118 th CONGRESS, SECOND SESSION b …

https://www.congress.gov/118/crec/2024/05/02/170/76/CREC-2024-05-02.pdf

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Guidance for the Interpretation of Significant Change of a Medical …

(Just Now) WEBThis guidance document elaborates upon the definition of "significant change" in the Regulations, in order to assist manufacturers in determining whether a …

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

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Medical Devices Regulations ( SOR /98-282) - laws.justice.gc.ca

(5 days ago) WEBFederal laws of Canada. 32.5 (1) Subject to subsection (2), the Minister may cease to recognize a person as a registrar if the Minister has reasonable grounds to believe that …

https://laws.justice.gc.ca/eng/regulations/sor-98-282/page-3.html

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Guidance on summary reports and issue-related analyses for

(1 days ago) WEBThe Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID …

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

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