Justice Canada Medical Devices Regulations

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 Regulations ( SOR /98-282)

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

Medical Devices Regulations ( SOR /98-282)

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-1.html

regulatory agency means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical …

Medical Devices Regulations ( SOR /98-282)

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

2 (1) Despite subsection 43.12 (1) of the Medical Devices Regulations, information in respect of a clinical study or investigational testing, as defined in …

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

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

Class II, III and IV Medical Devices Prohibition 26 Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of …

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

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-9.html

Rule 1: (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. (2) A surgically invasive device that is intended to diagnose, monitor, control or …

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-3.html

41 (1) The Minister may suspend a medical device licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety …

Medical Devices Regulations ( SOR /98-282)

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

3 The package is marked in distinct overprinting with the word “Export” or “Exportation”. 4 The medical device was not manufactured for consumption in Canada. 5 The medical …