Written By Ashley Paterson and Gina Azer

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Along with the notice and draft list of recognized standards, Health Canada also released a draft Guidance Document, which aims to help manufacturers use the standards to comply with the Medical Device Regulations, SOR/98-282 (the Regulations).

The Regulatory Framework for Licensing Medical Devices

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.

Proposed Changes to the Recognized Standards for Medical Devices

Substantively, the proposed changes to the standards will apply to device manufacturers seeking to obtain any of the following:

• a medical device licence for a Class II, III or IV device (section 32) and, if applicable, a medical device licence amendment;
• an authorization for special access (subsection 71(2));
• an authorization to sell or import a Class III or IV custom-made device (subsection 71(2));
• an authorization for investigational testing of a Class II, III or IV device (section 82); and
• an authorization for a device for urgent public health need (part 1.1).

The new standards address the following issues and related medical devices:

• Aseptic processing of health care products: sterilization requirements, specifically, bacterial endotoxin testing.
• Biological evaluation of medical devices: tests for irritation.
• Hemodialysis: systems for blood purification including hemodialysers, hemodiafilters, hemofilters and hemoconcentrator, and the preparation and quality management of fluids used in hemodialysis.

The updated standards will address the following issues and related medical devices:

• Biological evaluation of medical devices: tests for genotoxicity, carcinogenicity, reproductive toxicity, local effects after implantation and skin sensitization.
• Cardiovascular implants: specific requirements for durability testing for heart valve replacement devices.
• Medical gloves: standard specification for various medical gloves.
• Ophthalmic optics: particular testing threshold for allowable endotoxin levels in intraocular lenses and standard interpretation.

The removed standards addressed the following issues and related medical devices:

• Diagnostic devices: acoustic output measurement standards for diagnostic ultrasound devices.
• Hemodialysis devices: quality of dialysis fluid and water used in hemodialysis and related therapies.
• Medical electrical equipment: electromagnetic compatibility test standards.

Changes in Determining the Version of the Recognized Standards for 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.

Looking Forward

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.

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