Under the MDR, the shelf-life rule states that when importing a medical device with total shelf-life >1 year, the residual shelf-life must be at least what percent on date of import? (Drug Inspector Medical device-2025)
Under India’s MDR 2017, a manufacturer must notify the licensing authority within what time if there is a change in manufacturing site? (Drug Inspector Medical Device-2025)
Pravin Sirvi
Under the MDR, what is the maximum shelf-life permitted (ordinarily) for a medical device from date of manufacture, unless justified?
3 months ago | [YT] | 1
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Pravin Sirvi
Under the MDR, the shelf-life rule states that when importing a medical device with total shelf-life >1 year, the residual shelf-life must be at least what percent on date of import? (Drug Inspector Medical device-2025)
3 months ago | [YT] | 2
View 0 replies
Pravin Sirvi
Under India’s MDR 2017, a manufacturer must notify the licensing authority within what time if there is a change in manufacturing site? (Drug Inspector Medical Device-2025)
3 months ago | [YT] | 1
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Pravin Sirvi
Under India’s MDR 2017, which class of devices is considered high-risk? (Drug Inspector Medical Device-2025)
3 months ago | [YT] | 1
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