Medical Devices Shelf Life ---INDIA

mpfizer

Involved In Discussions
#1
Hi,

We are a medical device manufacturer based in India, we have an approved product list approved by CDSCO for sterile products with shelf life of five years , we want to label the products with an expiry of three years, is that legally possible or is it that since our approved list shows five years the label should also have only five years .

Any guidance from experts in the field in India or anywhere else in the world would be highly appreciated .How is this viewed wrt USFDA or EU countries.

Thanks

Michelle
 
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Ed Panek

QA RA Small Med Dev Company
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#3
I dont think its a problem. An auditor might ask why you did this. A memo to file describing why its done in a label review should be enough.
 
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