Differences in Medical Device Approvals in various countries (US, EU, Japan)

C

Cardinal Fan

#1
As a medical device design group we often redesign existing products. Over time we have seen a great deal of difference in the level of compliance with design control requirements for products that have been approved and on the market in various countries (US, EU, Japan). I have been tasked with trying to understand why these differences exist and would very much appreciate any input. Thank you!
 
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W

William_55401

#2
As you think about what is driving the differences, consider WHEN did the device first go onto the market and WHAT were the regulatory approval expectations at the time. Over time, the regulatory bar has been raised. This can be due to a change in the regulations for a particular market or, more often, in a change in how the regulations are enforced or what the regulatory bodies are expecting. For old designs, sometimes it is a good idea to remediate the design history file to ensure all the required design control elements are in place (and current) to the level of newly marketed products. Saying we don't have that information since it is a legacy product is a weak argument with the regulators. Hope this helps. Good luck.
 
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