On January 20, 2011 Health Canada issued a notice in regard to the “Guidance for the Interpretation of Significant Change of a Medical Device”. This newly released guidance document replaces the previous 2003 guidance document. The date of revision for this document is January 5, 2011 and the effective date, is a April 1, 2011. This guidance document includes updated examples of significant change and has been reformatted into Good Guidance Practices (GGP) format. In this new guidance document it provides a three-phased assessment tool that includes: 1) general principles in identifying a significant change; 2) a series of nine flowcharts ( “Main Flowchart”, Flowcharts A to H) to aid in decision making; 3) and a fairly detailed list of significant and non-significant change examples. The list for significant and non-significant changes includes: changes in manufacturing processes, facility or equipment; changes in design; changes in material; changes to labeling; changes to sterilization; and changes to software. The notice is repeated in full below:
Health Canada is pleased to announce the release of the Guidance for the Interpretation of Significant Changes.
The Medical Devices Regulations (Regulations) set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the Regulations is to ensure that medical devices offered for sale in Canada are safe and effective and meet quality standards. Class II, III and IV medical devices sold in Canada are required to be licensed under section 26 of the Regulations. Section 34 of the Regulations describes five instances when a manufacturer is obliged to apply for an amended medical device licence. One of those instances is when a “significant change” is proposed to a Class III or IV device.
This guidance document elaborates upon the definition of “significant change” in the Regulations, in order to assist manufacturers in determining whether a change proposed to a class III or IV medical device requires the submission to Health Canada of a licence amendment application, prior to introducing the device to the market.
This guidance document will replace the 2003 Guidance for the Interpretation of Significant Change of a Medical Device. The major changes include updated examples of significant changes and a restructuring of the guidance for additional clarity.
For further information on the revised Guidance for Industry: Guidance for the Interpretation of Significant Change of a Medical Device, please contact:
Manager, Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 Main Building
150 Tunney’s Pasture Driveway
Address Locator: 0301H1
Ottawa, Ontario
K1A 0K9
Email:
Phone: (613) 957-7285
Fax: (613) 957-6345