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Who Needs to Comply?

Overview​

The Medical Devices Regulations apply to multiple parties in the medical device supply chain. Understanding which obligations apply to your role is the first step in compliance.

Manufacturers​

A manufacturer is a person who sells a medical device under their own name, or who designs, fabricates, produces, packages, processes, or labels a device for sale, or who assigns a name or mark to a device for the purpose of establishing identification.

Obligations​

  • Obtain a Device Licence (Class II, III, IV) before selling in Canada
  • Meet the Safety and Effectiveness Requirements of Schedule 1
  • Implement and maintain a compliant Quality Management System (ISO 13485 / MDSAP)
  • Maintain compliant labelling (bilingual English/French)
  • Report mandatory problems within required timeframes
  • Initiate recalls when required
  • Maintain records adequate to support recalls

Foreign manufacturers​

Foreign manufacturers who sell devices in Canada do not need a Canadian agent, but they must hold a Device Licence (Class II–IV) in their own name. The Device Licence is issued to the manufacturer regardless of where they are located.

Importers​

An importer is a person who brings a medical device into Canada from a foreign country for the purpose of sale.

Obligations​

  • Hold a Medical Device Establishment Licence (MDEL) listing "importing" as a covered activity
  • Maintain a compliant QMS appropriate for importers (complaint handling, distribution records, recall procedures)
  • Report mandatory problems involving devices they import
  • Participate in recalls as directed by the manufacturer or Health Canada
  • Maintain distribution records that allow tracing of devices to the next level of the supply chain
note

An importer that also distributes takes on distributor obligations as well.

Distributors​

A distributor is a person who distributes a medical device at the wholesale level after it has been manufactured and imported.

Obligations​

  • Hold a Medical Device Establishment Licence (MDEL) listing "distributing" as a covered activity
  • Maintain a compliant QMS appropriate for distributors
  • Report mandatory problems involving devices they distribute
  • Participate in recalls when directed
  • Maintain distribution records for traceability

Retailers​

Retailers who sell medical devices directly to end users (e.g. pharmacies, medical supply stores) are not required to hold an MDEL, provided they only sell to end users. However, if a retailer also distributes at the wholesale level, MDEL obligations apply.

Healthcare institutions​

Hospitals and other healthcare institutions that use medical devices are generally not required to hold an MDEL or Device Licence. However, they may have obligations as users including:

  • Reporting serious incidents to manufacturers (and optionally to Health Canada via MedEffect)
  • Reprocessing single-use devices (specific guidance applies — see Reprocessed Single-Use Devices)

Consultants and regulatory affairs professionals​

Regulatory affairs consultants and professionals who act on behalf of regulated parties do not have personal obligations under the MDR, but they assist companies in meeting theirs. The regulated entity (manufacturer, importer, or distributor) remains legally responsible for compliance.

Summary table​

PartyDevice Licence needed?MDEL needed?
Canadian manufacturer (Class I)NoYes (as manufacturer)
Canadian manufacturer (Class II–IV)YesTypically yes
Foreign manufacturer (Class II–IV)YesNo
Importer (any class)NoYes
Wholesale distributor (any class)NoYes
Retailer (direct to end user only)NoNo
Healthcare institution (user)NoNo