Roadmap to meet
CDSCO Mandate for Class C & D Non Notified Medical Devices
Wednesday, September 13th, 2023 @ 3 PM IST
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To understand the licensing process from start to end.
Top Reasons to Watch
Introduction to the CDSCO Mandate
Why is CDSCO Mandate is necessary for class C and D devices
Gain clarity on the prerequisites and documentation necessary to comply with the new CDSCO regulations
The Roadmap to Successful Licensing with the new CDSCO Mandate
QnA Session
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Dr. Ashwini Kumar
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Shipra Bisht
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Ashwani Yadav
Assistant Manager - Medical Device
Frequently Asked Questions
What are Class C and D devices?
Class C and D devices are classified as moderate high risk and high-risk devices, respectively.
These classification is risk based and depends on the intended use of the device and also upon indications for use.
Why is licensing necessary for Class C and D devices?
For the transition to the licensing system, a transition period of 42 months from the day the notification of GSR 102[E], which was effect from April 1, 2020, and was made available for non-notified Class C and D devices.
Beginning on October 1, 2023, all Class C and D devices will be subject to licensing requirements under the category of notified medical devices.
What are the benefits of attending this webinar?
- Introduction to the CDSCO Mandate
- Why is CDSCO Mandate is necessary for class C and D devices
- Gain clarity on the prerequisites and documentation necessary to comply with the new CDSCO regulations
- The Roadmap to Successful Licensing with the new CDSCO Mandate
- QnA Session
When does the licensing mandate for Class C and D devices come into effect?
The licensing mandate for Class C and D devices is scheduled to begin on October 1st. This means that from that date onwards, manufacturers and Importers of these devices need to comply with the licensing requirements.
Will this webinar will be available in future?
Yes, the recording of this webinar will be available on the same page after the event.
Who all should attend this webinar?
Manufacturers and Importers of Class C and D devices need to attend this webinar.