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?
MDRTA Latest Questions
jyotisaxena5687@gmail.comTeacher
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?
How to include change in model name of device in existing import license?
VivekBeginner
For loan license device master file would be Submitted by actual manufacturers or by the person who is taking loan license?
Which division of CDSCO is responsible for review of IVD kits/reagents?
What are the activities regulated by the CLA & SLA with respect to In Vitro diagnostic in India?
Name and address of the Regulatory Authority that governs the regulations of Import of IVD kits/reagents in India?
Is any certification from Bureau of Indian Standards required for all Class A devices also?
jyotisaxena5687@gmail.comTeacher
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.