What Makes a Product a Medical Device?

When I was studying for my master's last year, there was a subject called Translation of Medical Devices. That subject covered the topic of the question above.


Earlier this month, I attended Demystifying the FDA — a virtual event hosted by the Medical Center of the Americas Foundation. There, the topic was addressed again with the following example:


Are infant diapers a medical device?



The answer is NO because they do not meet the definition of what a medical device is.


Infant diapers:


  • Are not intended to diagnose, cure, mitigate, treat, or prevent disease in humans.

  • Are not intended to affect the structure of any function of the body.

  • Do not achieve their primary intended purpose by chemical action or by being metabolized.


Like infant diapers, adult diapers are not intended to affect the structure of any function of the body. They do not achieve their primary intended purpose by chemical action or by being metabolized either.


However, adult diapers are intended to diagnose, cure, mitigate, treat, or prevent disease in humans.


Therefore, adult diapers are medical devices.


Verifying whether your health product is a medical device or not is essential to know how to market it.


How is a medical device defined in your country/region?

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