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1

MDEA IndiaBeginner

Asked: June 22, 2024In: Device Classification

classification of heart lung machine

1

what is the classification as per heart-lung machine?

1

BSCICBeginner

Asked: June 11, 2024In: Device Classification

Customized medical device packaging matenals. falls under which classification

1

Customized medical device packaging matenals. falls under which classification

1

VivekBeginner

Asked: May 14, 2024In: Regulatory

Does the Registration covers only Notified Devices or it covers all types of Medical Devices?

1

There are list of Medical Devices in the rules. And we also have Notified Medical Devices. So, what is the significance of Notified Devices? Will the Registration covers only Nitified Devices or it covers all types of Medical Devices?

2

Cory M. FunkBeginner

Asked: May 14, 2024In: MDR, 2017

Which certificate will be required for medical devices wholesale permit?

2

Dear Experts, Can someone please tell which certificate will be required for medical devices wholesale permit?

1

Cory M. FunkBeginner

Asked: May 14, 2024In: MDR, 2017

What are forms MD-41 and MD-42 about and where can I get detailed information about these?

1

What are forms MD-41 and MD-42 about and where can I get detailed information about these? It will be helpful if someone can please point me to the official documentation for the same.

1

DC TalksBeginner

Asked: May 10, 2024In: MDR, 2017

Is shelf life applicable to stainless steel and titanium medical device?

1

Is shelf life applicable to stainless steel and titanium medical device?

0

jyotisaxena5687@gmail.comTeacher

Asked: May 10, 2024In: Regulatory

If my base licence is gone through the retention, should I take renewed FSC for export of our medical devices ?

0

Hello, my base licence is being retention in June 2024, in that case, shall I have to reapply for FSC or it is not required to reapply?

0

VivekBeginner

Asked: May 10, 2024In: Regulatory

How to include change in model name of device in existing import license?

0

How to include change in model name of device in existing import license?

0

VivekBeginner

Asked: May 10, 2024In: MDR, 2017

What are the recommended real time and accelerated stability conditions?

0

What are the recommended real time and accelerated stability conditions?

3

jyotisaxena5687@gmail.comTeacher

Asked: May 7, 2024In: MDR, 2017

Are accelerated studies of shelf life time sufficient for claiming the shelf life of a Medical Device?

3

Fellow community members may please help on the above query.

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