Justice Canada Medical Device Regulations

Medical Devices Regulations ( SOR /98-282) - laws …

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

43.2 - Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision 43.2 - Application 43.3 - Notices to Commissioner of Patents 43.5 - Marking and Labelling 43.6 - Notice to Minister 44 - Establishment Licence 44 - …

Medical Devices Regulations ( SOR /98-282) - laws …

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

Medical Devices Regulations - laws-lois.justice.gc.ca

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

Medical Devices Regulations ( SOR /98-282)

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

10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical …

Medical Devices Regulations ( SOR /98-282)

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

(a) the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and (b) the risk that allowing the licence to continue to …

Medical Devices Regulations ( SOR /98-282) - laws …

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

26 Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the …

Medical Devices Regulations ( SOR /98-282)

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-4.html

52 (1) The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device. (2) Subsection (1) does not apply to (a) a …

Medical Devices Regulations ( SOR /98-282)

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

88 The requirements set out in the following provisions apply to medical devices to which this Part applies: (a) sections 52 to 56 with respect to distribution records; (b) sections 57 …

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 …