Canada Medical Device Regulations



Canada is one of the most regulated health authorities with updated regulation and governance allowing multiple and novel devices to be placed in the market. For new medical devices/ IVDs Health Canada emerges as one of the early implementers of medical device regulations with several strong and robust regulatory requirements

As per the Food and Drugs Act, Health Canada regulates the safety and efficacy of all medical devices marketed in Canada. Athreva with its medical device expertise can cater to regulatory requirements of manufacturers with a wide spectrum of services from device classifications to post marketing surveillance.

Regulatory assistance with formal classification of device with Health Canada

Support for obtaining Medical device establishment license (MDEL) for manufacturers

Diagnosis of existing technical documentation and compilation of Medical device licence technical file

Support with preparedness for MDSAP audit 

Health Canada Medical Device Registration


Health Canada Medical Device Regulations


Health Canada regulates the medical devices, IVD and SAMD in-country in line showing similarity with the USFDA. Based on the risk assessment and intended use, a classification system is adopted by HC by segregating devices into four (04) different classes – Class I, II, III, IV.


Device classification and Market entry support


A market entry for product in Canada calls for different routes of device entry. As a first step, manufacturer needs to understand the regulations that exists for the device, which can be determined by knowing the classification and its applicable regulatory framework.


As per HC, medical devices are classified into 4 risk-based categories:


Class I, Class II, Class III and Class IV

Legal Representative


How Athreva can assist medical device companies to classify the product in Canada

  • Product classification support
  • Gap analysis/ Diagnosis of existing technical file and generating a status report for analyzing regulatory requirements
  • Compilation and submission of Medical device license

Proper classification of medical devices under HCs guidelines is important to understand the correct scope of regulatory window that arises from the HC concerning the route of device entry.

This can further reduce the loop of regulatory submissions, approval, and expenses.


Compliance & QMS Services


Implementing and maintaining a Quality Management System (QMS) is a pivotal part of regulatory compliance for most markets around the world. Using Athreva’s expertise establish, maintain, and remediate your QMS.

As a part of Athreva’s QMS compliance services, we offer

  • Gap analysis to identify the applicable QMS standards
  • Support with Quality system ISO 13485 for Medical devices and IVD manufacturers by CMDCAS
  • Support and preparation for MDSAP program

Labeling, Artwork and Promotional Material Creation and Review


Athreva’s state-of-the-art in-house artwork studio and printing competency can assist medical device manufacturers with their labeling, artwork, printing and packaging requirements which are important and major cause of device recalls. It is imperative to ensure regulatory compliance of your label and promotional material according to the requirements as per HC. Inconsistent labels produced due to a lack of defined label creation process have far reaching implications – from concept finalization to final product sales. Dispensing with these issues needs a fresh approach and guiding hands of a domain expert.

Athreva can assist medical device companies in achieving end to end regulatory assistance and compliance with quality. We cater to the entire life cycle of the medical device value chain providing labeling and artwork solutions, right from comprehensive artwork check till regional language support.


Our labeling services includes following :

  • Regulatory support for labelling design as per HC labelling regulations
  • Gap analysis of the labels to meet regulatory requirements
  • Advise on promotional material design as per regulatory requirements

Our Artwork Studio and printing services includes following :

  • Creation of artworks as per HC requirement
  • Promotional artwork creations for Print as well as Web platforms
  • Proofreading of artworks
  • Printing of artworks in Packaging material.

Regulatory Strategy and Consulting


Evaluating a suitable regulatory strategy for a medical device for the Canadian market is a complex process for successful product development, registration, and commercialization. It entails a lot of efforts from cross-functional teams to develop the device from conception to submission along with proper understanding of regulatory strategy needs. Athreva can support in developing appropriate and effective regulatory strategies.

  • Classification approach for borderline products with approach and justification
  • Advise for combinational products submission
  • Technical analysis of the product changes and categorization to critical and noncritical changes
  • Updation of the technical file with the changes for submission to Health Canada requirements
  • Regulatory advice on the change’s implementation with supporting documentation


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