On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified Medical Devices” which presents new categories for the classification of non notified devices (not regulated by Indian regulations), based on the risk class.
In order to simplify the classification process of all types of Medical Devices, CDSCO established 24 categories based both on subdivisions applied at internationally acceptable classification and on the First Schedule of Medical Device Rules, 2017.
Medical Device and IVD classification
Among the 24 categories of medical devices, CDSCO inserted for the first time the software that includes 60 types of products as, for example, data analysis software, software for radiotherapy, hemodynamic, radiology, orthodontic software and other devices.
A number of commonly used products, such as glasses (lenses and frames) and contact lenses has been included in the list.
Three categories have been established for IVDs: IVD analyzers (53 individual IVD types), IVD instruments (18 device types), and IVD software (9 device types).
Deadline for registrations
By August 2022 all the low-risk Class A and moderate low-risk Class B devices must be registered with the CDSCO. By August 2023 all the moderate high-risk Class C and high-risk Class D devices must be registered.
It is therefore essential for companies to verify as soon as possible whether their devices are included in the list published by CDSCO, verifying the documentation necessary for registration.
Do you need more information about DM and IVD regulations in India?
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