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.
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.