CANADA Medical Device Consulting Services

CANADA Medical Device Consulting Services

🍁 Canada Medical Device Registration Overview

Canada regulates medical devices under the Medical Devices Regulations (SOR/98-282), overseen by Health Canada’s Therapeutic Products Directorate (TPD). Compliance requires both device licensing and, in many cases, an Establishment Licence (MDEL).


Medical Device Establishment Licensing (MDEL)

  • Manufacturers of Class II, III, and IV devices must obtain a licence before importing, advertising, or selling.
  • Distributors cannot legally sell unlicensed devices and must hold an Establishment Licence.
  • Exemptions include:
  • Retailers
  • Healthcare facilities
  • Manufacturers selling only their own licensed devices, custom-made devices, or those under special access/investigational testing
  • Class I manufacturers distributing solely through licensed establishments
  • Persons selling devices subject to Parts 2 and 3 of the Regulations
  • Dispensers


Labelling Requirements

  • All imported or sold medical devices must comply with Canadian labelling requirements, ensuring bilingual (English/French) information, intended use, safety instructions, and manufacturer details.


Classification

  • Devices are classified into Class I, II, III, and IV based on risk.
  • The MDEL application must specify the classes of devices being imported or sold.


Device Licensing

  • Class II, III, and IV devices require a valid Medical Device Licence issued by Health Canada before sale.
  • Class I devices do not require a licence but must comply with general safety and labelling requirements.


Our Services

We provide end-to-end support for medical device companies entering the Canadian market:

  • Guidance on MDEL applications and exemptions
  • Preparation and submission of device licence applications for Class II–IV devices
  • Review and alignment of labelling with Canadian bilingual requirements
  • Strategic advice on classification and regulatory pathways
  • Ongoing compliance support for importers, distributors, and manufacturers
  • Representation and readiness for Health Canada inspections and audits


In Summary

Canada’s regulatory framework requires careful navigation of both device licensing and establishment licensing. With our combined industry and legal expertise, we ensure your medical devices meet Health Canada’s requirements, enabling smooth market entry and sustained compliance.