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Health Canada clarifies “significant change” qualifications to Medical Device Licenses following Sterigenix shutdown

Regulatory Updates | Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada clarifies which changes in sterilization processes would require Medical Device License amendment applications;
  • Impact of Sterigenics sterilization facility in the US on MDL holders still being assessed.

Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.

In a recent email to stakeholders, Health Canada followed up on a previous notice establishing a process whereby MDL holders in need of alternate sterilization providers after the Sterigenics facility shutdown in Illinois could notify the regulator. That notice also pointed out that in some cases, changes in sterilization procedures could require “significant changes” and license amendments.

Sterilization methods and MDL change amendments

In general, Health Canada advises that changes in facilities alone—that is, with no changes to a device, its packaging or method of sterilization—would not warrant a new MDL application submission. The regulator cites its significant change guidance, pointing out the following changes that would require filing amendments to MDLs:

  • Changes that increase bioburden alerts or action levels;
  • Changes that introduce organisms more resistant to sterilization effects;
  • Device design and material changes that introduce features more difficult to sterilize;
  • Changes in sterilization processes, equipment or cycle parameters;
  • Changes in density or configuration of a sterilization load;
  • Changes to quality control verification and validation processes.

Health Canada adds that moving a sterilization process to a new facility may include changes to the sterilization process, equipment and/or cycle parameters; the Sterigenics facility in the US used ethylene oxide sterilization methods, for example, but alternate sterilization sites may not. In such cases, changes in process would qualify as significant changes, according to the regulator.

MDL holders with devices impacted by the Sterigenics shutdown may still email Health Canada’s Regulatory Operations and Enforcement Branch to notify the regulator of any potential supply issues.

Learn more about Health Canada medical device regulations at Emergo by UL:

  • Health Canada MDL and MDEL registration consulting
  • CMDCAS, MDSAP and Health Canada ISO 13485 quality system compliance
  • Medical device sterilization testing and cleaning validation support
  • Whitepaper: Preparing a Canadian MDL application
  • Whitepaper: Overview of ISO 11135:2014 and medical device sterilization

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