Are there any Zinc oxide devices under class III
When does Zinc oxide get classified as medicinal product instead of medical device. When does rule 13 classification apply.
Any Zinc oxide products under Class I or III available in the global market?
Thank you very much
RA
Hi,
From your reference to classification rule 13 I gather that you refer to the EU system, although this thread is posted in a US regulation forum.
To your first question, I don't know the answer and I don't know a quick, generic way to find out - there's no public-accessible central database for devices registered in the EU. An answer might be found through anecdotal knowledge of such devices and maybe through a general web search.
To answer your second question - generally, a substance is considered a medicine rather than a medical device when its primary mode of operation is via pharmacological, immunological or metabolic (PIorM) means. I'm not an expert on Zinc Oxide; the two related uses of that substance that I'm familiar with are as a sunscreen ingredient (physical reflector) and in Calamine lotion. I can't say for sure what exactly is the chemical / otherwise mechanism in which Zinc Oxide operates in those two uses but I'm inclined to say that it's not PIorM, and thus that substance (if considered alone) would be classified as medical-device-like. Anyway, ZnO is not normally presented independently, but rather as part of a compound that might be considered either medicinal or a medical device.
Rule 13 applies when discussing a combination device in which the medicinal component is ancillary to the device component, ie the complete combination device's primary mode of operation is not PIorM. If Zinc Oxide, as an ingredient of a medical device, does not act via PIorM means (and thus not considered a medicinal product), rule 13 is irrelevant to it.
I haven't checked the classification of any sunscreen or Calamine lotion products on the market but I'd venture a guess that at least some are classified as EU class I medical devices. I wouldn't know regarding class III. Again, some web research could probably provide solid answers.
Cheers,
Ronen.
Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 65/65/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.
All devices incorporating, as an integral part, a human blood derivative are in Class III.