2011年 1月 27日
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: