Question 1

Can anybody import and sell a Class II, III or IV Medical Device in Canada?

Accepted Answer

Only Licensed Health Canada Medical Device Establishments can import or  distribute Class II & III and IV Medical Devices. You can  authenticate your distributor through this link;  http://webprod5.hc-sc.gc.ca/el-le/prepare-search-recherche-mdel-lepim.do?lang=eng

Question 2

What Laws govern Class II, III or IV Medical Devices in Canada?

Accepted Answer

It is Canadian Law not “just a safety organization” http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-5.html#h-11

Question 3

If a Class II, III or IV Medical device has CSA Approval but does not have Health Canada Approval, is it legal to be in Canada?

Accepted Answer

No, CSA is an electrical safety approval only and has nothing to do with Health Canada Medical Device Licence approvals.

Question 4

What type of Class II, III & IV Aesthetic Medical Device be legally used on humans in Canada?

Accepted Answer

Only Health Canada Approved Class II, III, IV Medical Devices can be used on humans in Canada.

Question 5

Can any Class II, III & IV Aesthetic Medical Device be legally imported into Canada?

Accepted Answer

No, Only Health Canada Approved Class II, III, IV Medical Devices can  ONLY be Imported into Canada and ONLY by a Licenced Health Canada  Medical Device Establishment.

Question 6

What type of Class II, III & IV Aesthetic Medical Devices, can be legally sold, advertised or offered for sale in Canada?

Accepted Answer

Only Health Canada Approved Class II, III, IV Medical Devices can be offered, advertised for sale, or sold into Canada.

Question 7

How do I know if a Class II, III or IV Medical Devices has a Health Canada Licence?

Accepted Answer

Search Engine such as link below will provide the answer…if a number is  not found then the device is considered an illegal medical device in  Canada
http://webprod5.hc-sc.gc.ca/mdll-limh/prepareSearch-preparerRecherche.do?type=active&lang=eng

Question 8

What common Aesthetic Medical Devices are considered Class II, III or IV Medical Devices in Canada?

Accepted Answer

IPL, Laser and RF devices are all Class II & III and must have a valid Health Canada Medical Device Licence Number.

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