Health Canada Compliance
In order to market health products in Canada, manufacturers, private labelers, importers and distributors must be in compliance with the Canadian laws and regulations for marketing of food, drugs and medical devices. The federal regulatory authority responsible for the sale of medical devices and drugs in Canada is Health Canada with its internal offices of Therapeutic Products Directorate and Medical Devices Bureau. mdi Consultants has extensive experience with various regulatory submissions to Health Canada and can assist with bringing your products to Canadian market.
Our Health Canada services include:
- Medical Device Classification
- Medical Device Licensing for class II, III and IV
- Establishment Licensing
- Private Label Licensing
- Label Review
- Quality system ISO 13485 certification by CMDCAS recognized registrars
Medical Device Classification
The regulatory submission requirements and manufacturer compliance requirements vary greatly depending on the classification of your medical device. Therefore, it is extremely important to first properly classify your product. 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 and determine if it is class I, II, III or IV.
It also needs to be noted that Health Canada’s definitions for medical devices and corresponding device class may not be the same as in other countries. For example, products that are known to be medical devices in USA or EU could be defined as drugs in Canada. Accordingly, experts qualified in Health Canada regulations will properly classify your product and 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 product’s time to 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.
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
In today’s competitive environment, many firms want to market and distribute medical device products produced by original manufacturers under their own private labels. Health Canada regulations have provisions for such private label 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 so that the products could continue to be marketed. It is obviously best to define appropriate requirements from the very beginning and 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.
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.
Quality system ISO 13485 certification by CMDCAS recognized registrars:
In accordance with Health Canada regulations, all manufacturers of class II, III and IV medical devices must be in compliance with ISO 13485 quality system. The licensing of medical devices is not possible without a manufacturer first obtaining a quality system certificate as evidence of compliance to the quality system requirements. Health Canada only recognizes certificates that are issued by a third party auditing organizations called Canadian Medical Device Conformity Assessment System (CMDCAS).
mdi Consultants can help your organization achieve compliance to the required quality system. In addition, we will help with the selection of a CMDCAS notified body acceptable for Health Canada licensing purposes and be present during the certification audit. Visit our ISO Compliance page for more information.