Post registration variation to medical device

Nicky

Registered
#1
Hello everyone,

Need to find if any variation document present for medical device variations in different countries. The changes are
- Coating change for injector
- Shelf life change
-carton design change
-supplier change

Mainly interested in shelf life change requirements and timing since that is a major change. Any information would be greatly appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello everyone,

Need to find if any variation document present for medical device variations in different countries. The changes are
- Coating change for injector
- Shelf life change
-carton design change
-supplier change

Mainly interested in shelf life change requirements and timing since that is a major change. Any information would be greatly appreciated.
Not sure what exactly you are looking for.
Additionally, it will help if you could be more specific about the countries of interest.
 
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