To understand the licensing process from start to end.
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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.
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.
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.
Yes, the recording of this webinar will be available on the same page after the event.
Manufacturers and Importers of Class C and D devices need to attend this webinar.