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I’m a distributor that imports devices into Canada.  Do I need to certify to ISO 13488/13485?

The MDR do not require importers or distributors of medical devices to have a registered quality system. However, any importer or distributor of a Class II, III or IV devices that chooses to become the legal manufacturer by labeling and selling the device with their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by them (see section 1.4 below for the definition of manufacturer) shall comply with the applicable quality system requirement plus other applicable requirements of the MDR.

Note that: no one may import for sale or for use on individuals (other than importation for personal use) or sell a Class II, III or IV medical device in Canada unless the device has a valid licence. 

 Quick Facts:

All Canadian importers and distributors of medical devices will be required to obtain an establishment licence prior to initiating sale of medical devices in Canada

Manufacturers of Class II, III and IV devices are not required to obtain an establishment licence - unless they also manufacture Class I devices

Manufacturers of Class II, III and IV devices are required to obtain an establishment licence if they manufacturer of class II, III or IV devices that only sells

devices for which they hold a licence, or

devices subject to Part 2 and 3 of the Regulations (see webpage reference)

Manufacturers of Class I devices are required to obtain an establishment licence unless they have a Canadian importer or distributor acting on their behalf

Where a manufacturer also distributes devices that are not manufactured by their company, they are required to licence their establishment as a distributor