Zinc Oxide as a Topical Application

Dr RA

Involved In Discussions
#1
Hi
Has anyone come across Zinc Oxide cream/ointment/spray/emollient as Class I or III medical device of MDD.

Rule 13 indicates it as class III, how does it qualify as class I.

Many Thanks
RA
 
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Dr RA

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#3
Thanks Steve, I have already looked at the Borderline manual, it further confuses as rightly mentioned by you.
 

chris1price

Trusted Information Resource
#4
It comes down to the mechanism by which the zinc oxide acts. If it acts primarily as a barrier to stop bacteria passing or skin being scratched, then it is a medical device. However, if it has a pharmacological action then it is a medicine. If it does both (barrier and pharacological actions) then it is a medicine.

So you woulkd need to look carefuly at the indications, claims, etc of the product to determine the primary action.

It could only be Class 1 if it acted as a bandage and had no medicinal action whatsoever.

Chris
 

Dr RA

Involved In Discussions
#5
Thank you Chris1price, I have raised the question to NB's with the same statement mentioned by you on claim of the product.

Thanks again
RA
 
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