jyotisaxena5687@gmail.com – Questions – MDRTA

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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 ?

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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?

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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jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: MDR, 2017

How are IVDs classified in India under Medical Device Rules, 2017?

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How are IVDs classified in India under Medical Device Rules, 2017?

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jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: Others

What is an In-Vitro Diagnostic (IVD)?

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What is an In-Vitro Diagnostic (IVD)?

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jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: Others

Can someone please provide the list of medical device laboratories?

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Can someone please provide the list of medical device laboratories?

1

jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: Regulatory

Is BIS required for Class A devices?

1

Is any certification from Bureau of Indian Standards required for all Class A devices also?

1

jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: Regulatory

What is the process of getting a license for manufacturing a Class C device?

1

Can someone please give the details of the process of getting manufacturing a Class C device? It will be helpful if you could please include details like the forms to be submitted and how much time it can take.