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Product Liability for Dental Gel - Class I Medical Device

J

jaskosk

#1
Dear ELSMAR users,
Hello
I hope that You will help me.
I want to register our product (dental gel - for protection of oral wounds) as medical device in class 1.
Our representative person ask from us - Product liability insurance.
Please, do You know on which sum we need to insure our gel ? One approximation.
Thanks in advanced,
Yasko
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

First, please make sure that it is a medical device and not a medicinal product ("...does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means").

I'm not aware of a specific number for product liability insurance sum, in the relevant regulation. I think it is a matter of risk management -- what consequences can the device use have, how many adverse events / claims would you expect in one year, how much would you expect the cost of each claim to be etc.

As a very rough figure, $US10-15 million PA is perceived as sufficient for the majority of simple devices.

Cheers,
Ronen.
 
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