Medical device manufacturers licensed to sell their products in Canada have been notified that recent changes in the production process of a widely used device packaging material will require some firms to file significant change amendments with Health Canada, Emergo Group has learned.

Health Canada’s notice to Medical Device License (MDL) holders relates to recent manufacturing changes implemented by DuPont for that firm’s Tyvek® packaging material; Tyvek is used extensively for sterile medical device packaging.

Impact on Class III and IV devices

DuPont plans to provide testing data on its reformulated Tyvek product to regulators and manufacturers in various markets. MDL holders selling Class III and IV sterile devices in Canada will be required to determine whether changes to the Tyvek manufacturing process will apply to their own existing packaging and sterilization processes.

• If so, those manufacturers must notify Health Canada of their specific MDLs affected by the Tyvek changes, and attest that their configurations and sterilization methods are in line with DuPont’s new testing data.
• If not, manufacturers must determine whether the Tyvek reconfiguration will compromise their products’ sterility over their stated shelf life.
• If a manufacturer determines that the Tyvek reconfiguration will impact a device’s sterility over its stated shelf life, the firm must submit a Medical Device License Amendment Application for a manufacturing change, as well as provide supporting data such as sterilization and shelf-life validation or package integrity assessments.

Less impact on Class II devices

MDL holders selling Class II medical devices in Canada will not be required to file notifications or license amendments to Health Canada. However, the regulator advises these firms to utilize proper risk assessment procedures to ensure compliance with the Canadian Medical Devices Regulations.

Broader implications?

DuPont’s Tyvek packaging material is heavily used not just in Canada, but in medical device markets worldwide. Will Health Canada’s response to DuPont’s manufacturing change prompt other regulators to take similar steps in their jurisdictions? Canada will likely prove the first of many markets where manufacturers will need to amend their device registrations to reflect packaging material changes.

Stewart Eisenhart