Health Canada has published new guidance defining when manufacturers’ altering of their Class III and Class IV devices constitutes “significant change,” affecting medical device licenses.

The regulator’s Guidance for the Interpretation of Significant Change has important ramifications for manufacturers whose proposed changes to their products qualify as significant changes, because that qualification requires submission of license amendment applications to HC.

The guidance replaces the 2003 Guidance for  the Interpretation of Significant Change of a Medical Device, and is intended to clarify (if not tighten) requirements in Canada’s Medical Device Regulations pertaining to how Class III and IV devices are licensed for sale in the country.

A three-phase assessment tool comprising general principals in identifying significant changes, flow charts to support manufacturers’ decision making, and a list of significant and non-significant examples is provided in the new guidance document.

Key provisions of the new guidance:

• If a manufacturer determines it has made a significant change to a medical device, the modified device can only be introduced to the Canadian market upon receipt of an amended medical device license from HC
• Any labeling change adding a contraindication, warning or precaution affecting public health should be immediately implemented along with submission of a license amendment application to HC
• Manufacturers must document any and all changes made in their quality management systems, and report non-significant changes to devices must be reported to HC during the annual license renewal process.