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MDRTA community is a place which connects people who have knowledge to the people who need it, to bring together people with different perspectives so they can understand the Medical Device Industry better, and to empower everyone to share their knowledge.

1

VivekBeginner

Asked: May 6, 2024In: Regulatory

Activities regulated by the CLA & SLA

1

What are the activities regulated by the CLA & SLA with respect to In Vitro diagnostic in India?

1

VivekBeginner

Asked: May 6, 2024In: Regulatory

Which division of CDSCO is responsible for review of IVD kits/reagents ?

1

Which division of CDSCO is responsible for review of IVD kits/reagents?

0

jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: Others

What is an In-Vitro Diagnostic (IVD)?

0

What is an In-Vitro Diagnostic (IVD)?

0

jyotisaxena5687@gmail.comTeacher

Asked: May 6, 2024In: MDR, 2017

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

0

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

1

VivekBeginner

Asked: May 6, 2024In: MDR, 2017

Whether any product, intended for use in determining the presence of host cell protein contamination, in products manufactured by expression in the CHO cell line and other technology for Research and manufacturing use only and is not intended for diagnostic use in humans or animals, are being regulated under the provision of Medical Device Rules 2017?

1

Whether any product, intended for use in determining the presence of host cell protein contamination, in products manufactured by expression in the CHO cell line and other technology for Research and manufacturing use only and is not intended for diagnostic ...

2

VivekBeginner

Asked: May 6, 2024In: Device Classification

Thermometer comes under which class of medical device?

2

Can you explain thermometer comes under which class of medical device?

1

VivekBeginner

Asked: May 6, 2024In: MDR, 2017

What is loan license?

1

Can anyone please explain what is meant by a loan license?

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