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Is there an annual review required for Class II in vitro diagnostic medical device MDL registration?How long does it take to obtain Class II in vitro diagnostic medical device MDL registration?
Release time：2024-10-30 10:53:27 The author: source:
For Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, there is no mandatory annual review required by Health Canada. However, manufacturers are responsible for maintaining compliance with regulatory standards and may need to update their licenses if there are significant changes to the device or its labeling, or if new safety or efficacy data arises.

Annual Review Requirement

For Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, there is no mandatory annual review required by Health Canada. However, manufacturers are responsible for maintaining compliance with regulatory standards and may need to update their licenses if there are significant changes to the device or its labeling, or if new safety or efficacy data arises.

Timeframe for Obtaining MDL Registration

The timeframe to obtain a Class II IVD MDL can vary, but here’s a general estimate:

  • Preparation Phase: Several weeks to several months, depending on the complexity of the device and the readiness of documentation.
  • Health Canada Review: Typically takes 60 to 120 days, but this can extend longer if additional information is requested or if there are complexities in the review process.

Summary

  • Annual Review: Not required, but ongoing compliance is essential.
  • Time to Obtain MDL: Overall, the process can take several months, including preparation and Health Canada’s review.

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