The Notified Devices are the list of devices regulated under Medical Devices Rules (MDR), 2017 by the CDSCO - the Health Agency overseeing the regulation of medical devices in India. The CDSCO has released two notifications in February 2020 including, the amendment - Medical Devices (Amendment) Rules, 2020, which was effective from April 1, 2020. The other notification included new definition of medical devices. As per the amendment and the new definition, all the devices are now being regulated by the CDSCO. Prior to these notifications, only 37 categories of devices and IVDs were regulated in India. The new devices brought under the purview of the CDSCO are called as, “Newly Notified Devices”.
How are the Notified Devices Classified?
The “Newly Notified Devices“ include 24 categories of Medical Devices and three (3) categories of IVDs. Both Notified and Newly Notified devices are classified into four (4) Classes based on the risk associated with each of the device - Class A, B, C and D. Class A devices are low-risk devices and Class D devices are of the highest-risk.
What Are the Regulatory Requirements for Marketing of Notified Devices in India?
The Notified devices manufactured in India shall obtain Manufacturing License (ML) from the CDSCO and the devices manufactured in foreign countries shall obtain Import License (IL).
What Are the Regulatory Requirements for Marketing of Newly Notified Devices in India?
The Newly Notified Medical Devices should be listed by October 1, 2021. This listing does not include document evaluation by the agency and is voluntary till October 1, 2021. The Newly Notified Devices are subjected to full registration and shall have either import or Manufacturing license. Based on the type of risk class of the device, the timelines vary. Class A and B devices shall be registered by August 11, 2022 and Class C and Class D devices shall be registered by August 11, 2023.
What Are the Document Requirements for Listing of Newly Notified Devices in India?
The listing requires the manufacturers to submit basic information such as, manufacturer and manufacturing site details, device details, ISO 13485:2016 certificate, Free Sales Certificate (FSC) or Certificate of Free Sales (CFS) (issued by Country of Origin (COO) for imported device) and undertaking by the applicant.
What Are the Suggested Timelines for Initiating Licensing Activities?
Importers of all device classes should start initiating their licensing activities at least one (1) year before the legislative timelines that are imposed by the Agency, in case of newly notified devices or the target date for launch of device in the Indian market, or in case of Notified devices. The Indian manufacturers of Class A devices should start working on the application from 3-4 months; Class B devices manufacturers from 6 months; and Class C and D devices manufacturers from 5-7 months before the legislative timelines imposed by the Agency in case of newly notified devices or the target date for launch of device in the Indian market or in case of notified devices.
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