Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized Standards for Medical Devices for stakeholder consultation. The proposed changes will impact the process to license various classes of medical devices in Canada.
The proposed changes address: (1) new, updated and removed standards; and (2) a new method for determining which version of the standards to use when the versions are listed without years and editions.
Along with the notice and draft list of recognized standards, Health Canada also released a draft Guidance Document, which aims to help manufacturers use the standards to comply with the Medical Device Regulations, SOR/98-282 (the Regulations).
All medical devices must meet certain safety, effectiveness, and labelling requirements under the Regulations. To clarify these requirements, Health Canada relies on standards described in documents issued by national and international standards organizations. These standards documents provide requirements, specifications, guidelines, and characteristics ensuring that materials, products, processes, and services are fit for their intended purposes. Health Canada updates the list of recognized standards for medical devices periodically in collaboration with its international counterparts and agencies, including the U.S. Food and Drug Administration, to harmonize regulatory submissions for medical devices across jurisdictions.
Conformance with these standards is voluntary but can reduce regulatory obstacles to medical device licensing. If a manufacturer chooses not to conform to a particular standard set by Health Canada, it must show that it meets a higher standard, or provide alternative evidence of safety and efficacy. In circumstances where the manufacturer conforms with the standard(s) under the Regulations, it may be able to submit a Declaration of Conformity Form and eliminate the need for review of certain aspects of a medical device application.
Substantively, the proposed changes to the standards will apply to device manufacturers seeking to obtain any of the following:
The new standards address the following issues and related medical devices:
The updated standards will address the following issues and related medical devices:
The removed standards addressed the following issues and related medical devices:
Health Canada has also identified a new method for determining which version of the standards to use when the versions are listed without years and editions. When a new version of one of these standards is published, Health Canada will recognize the most recent version and the previous version, including any amendments or corrigenda, for three years.
The three-year transition period begins on the date of the latest published version. Any transition period specified in the latest version of the standard supersedes the three-year transition period, unless otherwise stated in the list of recognized standards.
By introducing the proposed changes discussed above, Health Canada hopes to continue to promote consistency in recognized standards for medical devices across jurisdictions and help reduce regulatory obstacles while allowing safe, effective, and quality products to enter the market.
While the updated list of recognized standards will have an impact on new device licences as well as new licence amendments or authorizations, licenses and authorizations under the previous standards will remain valid.
As a general rule, manufacturers seeking a device licence or authorization should review Health Canada's draft List of Recognized Standards. Manufacturers should also review any additional federal, provincial and territorial or municipal regulations, acts and certifications, which are separate and distinct from the Regulations, and that may apply to their medical devices.
Many of the standards set by Health Canada align with testing requirements and standards that arise in product liability litigation. Of course, it will be important to show in any negligent design case that appropriate testing was done and regulatory standards were met. Further, in negligent manufacturing cases, it is important to show that product manufacturing was carried out in accordance with applicable specifications.
Those who believe their business might be impacted by the proposed changes can provide comments on the new standards before the consultation period closes.