Just a quick question. If I have equipment that generates oxygen for medical applications, and the machine only generates and fills the oxygen tanks, which are then used in hospitals, etc, is the generating equipment a medical device? If so, what would be the classification?
It sounds to me a bit like equipment that is used to manufacture medicines for instance, and in my opinion it should not be classified as a medical device.
Your input will be greatly appreciated. We need to urgently clear this, because my client is importing the equipment to ***, and we need to know what registrations, etc, we need to apply. It is because medical devices are regulated in ***, but we apply more or less the same requirements as the EU.
To my understanding of this equipment, equipment that generates oxygen for medical applications is not a medical device. A medical device is the oxygen tank if that oxygen has a medical device purpose and not as medicine.