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Health Canada Regulatory Consulting services

Health Canada Compliance for Medical Devices and Health Care Products

Health Canada

Marketing Medical Devices in Canada, the manufacturers, private labelers, importers, and distributors of Medical Devices are required to meet all requirements of the Canadian Federal Regulatory Authority, and its agency responsible for the sale of medical devices, Health Canada, with its internal offices of Therapeutic Products Directorate and Medical Devices Bureau.

mdi Consultants provides superior Health Canada Regulatory consulting services with its extensive experience of various regulatory submissions to Health Canada and can assist with bringing your products to Canadian market.

mdi Consultants Health Canada Consulting services include:

  • Medical Device Classification
  • Medical Device Licensing for class II, III and IV
  • Establishment Licensing
  • Private Label Licensing
  • Label Review
  • MDSAP implementation and  certification assistance

mdi Consultants Health Canada services

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The Pathways to Canadian Medical Device Compliance

Health Canada Medical Device Classification

Canadian Medical Device regulatory submission requirements, and Health Canada medical device compliance requirements for manufacturers, vary greatly depending on the classification of your medical device. Therefore, it is extremely important to properly classify your product before moving forward. If confirmed that your product is indeed a medical device, in accordance with the Canadian classification system, mdi Consultants will evaluate the device risk classifications to determine if it is class I, II, III or IV.


Health Canada’s definitions for medical devices, and their corresponding device class, may not be the same as in other countries. For example, products known to be medical devices in the U.S. or EU could be defined as drugs in Canada. Accordingly, experts qualified in Health Canada regulations will properly classify your medical device product, associated licensing, and compliance requirements from the very beginning. This will help your company avoid unnecessary delays with Canadian regulatory authorities, and ultimately save your medical devices time to the Canadian market.

Medical Device Licensing for class II, III and IV

As explained above, a device risk-based classification system is used to determine the required submission application type to Health Canada. Medical devices classified as class II, III and IV must be reviewed and licensed by Health Canada before they can be sold on the market place. The submission complexity is dependent on the device class with submissions for class IV devices being the most complex.

mdi Consultants has assisted numerous clients with various medical device license applications that resulted in successful marketing authorizations. Our expertise with the Health Canada application and review process assures that client’s submissions are properly prepared so that time delays due to Health Canada’s requests for additional information are minimized and avoided.

In addition to our assistance with new medical device license applications, our scope of services also includes various license amendment applications due to device related changes, labeling changes, changes to the name of licensed devices and other.

Establishment Licensing

Similar to defining the submission and compliance requirements for various classes of medical devices, the Canadian regulations state that manufacturing establishment licensing requirements must be evaluated and complied with, if applicable. mdi Consultants will help you determine if your organization is subject to the site licensing requirements based on the type of your operational activities and products handled.

mdi Consultants will assist with preparation and filing of a Medical Device Establishment License (MDEL) application. If it is determined that as part of your MDEL signed attestation, additional assistance is needed to achieve the required level of procedural compliance, we will work with your company to assure all needed procedures are properly established and implemented.

We will also review if any of your marketed or to be marketed products require product registrations and can work with your firm on filing these applications as well to assure compliance with Canadian regulations.

Private Label Licensing

Marketing and distributing Medical Device Products In today’s competitive environment, finds many firms wanting to market medical device products, from the original manufacturers, under their own private labels. Health Canada regulations have provisions for such private label Medical Device arrangements, as long as appropriate licenses are in place.

We had a number of private label clients, who were unfamiliar with the Canadian regulations applicable to them which resulted in unfortunate loss of income. Once contacted, . mdi Consultants was able to successfully resolve the situation by applying for appropriate license, to insure the products could continue to be marketed in Canada. It is obviously best to define appropriate requirements from the very beginning, to assure continuous compliance.

mdi Consultants will gladly advise private label companies on the arrangements they have with the device manufacturers as well as the applicable licensure requirements. We will work with your company on securing appropriate licenses with Health Canada. Additionally, we can evaluate compliance of a private labeler company with provisions of the Food and Drugs Act and Medical Devices Regulations to assure they have systems in place to handle complaints, mandatory problem reporting to Health Canada and recalls.

Label Review

Canadian regulations specify requirements for product labeling and labels are routinely reviewed as part of premarketing authorization submission. mdi Consultants will review your labeling materials such as product labels, package labels, user manuals, direction inserts to assure the labeling is in conformance with Canadian regulations. We will issue a written label review that if needed, will specify the label changes to bring the labeling in compliance. In reviewing your labeling, we look for ways to effectively present and maximize your product marketing claim while preserving the label accuracy and consistency with the indications for use.

Medical Device Single Audit Program (MDSAP) implementation and certification assistance

In accordance with Health Canada regulations, all manufacturers of class II, III and IV medical devices must have compliance with the MDSAP (Medical Device Single Audit Program) system. The licensing of medical devices is not possible without a manufacturer first obtaining a MDSAP certification as evidence of compliance to the quality system requirements.

Health Canada recognizes only those certificates issued by third-party auditing organizations called Certified Bodies.

mdi Consultants can help your organization meet the requirements of the MDSAP program In addition, we will help with the selection of a Certified Body acceptable for Health Canada licensing purposes and be present during the MDSAP certification audit.

Visit our ISO Compliance page for more information.