Regulation/Guidelines

New Classifications Of Non-Notified Medical Devices And IVDs In India By CDSCO

  • 9th November, 2020
New classifications of non-notified medical devices and IVDs in India by CDSCO

The Central Drugs Standard Control Organisation (CDSCO) has released two notices on September 3, 2020, including the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs). To simplify the classification process of all types of medical devices, CDSCO established 24 categories based on subdivisions applied at internationally acceptable classification and on the First Schedule of Medical Device Rules, 2017. This is a significant development for Indian Pharmaceuticals and Medical Devices. The notice provides new risk-based classification lists for medical devices and IVD products to manage India’s clear regulatory pathways and requirements. Though the notice does provide regulatory clarity to Indian medical device regulations for non-notified devices, IVDs in particular, these proposals would introduce significant new compliance requirements for market access.

CDSCO has classified almost 1866 medical devices and 80 IVDs. There are 24 categories of medical devices and 3 Categories of Non- Notified In-Vitro Diagnostic Medical Device proposed by CDSCO

  • IVD analyzers (53 individual IVD types)
  • IVD instruments (18 device types)
  • IVD software (nine device types)

The new regulation will help to classify the devices and registration appropriately by the manufacturers. All the medical device registration needs to be done in a phase-wise manner.  

Risk based classificationIVDS
Class A12
Class B38
Class C28
Class D2

Classification of Medical devices-A new addition

Out of the 24 medical device classifications, CDSCO has included software as a category for the first time in the regulation. The category would include 60 device types such as data analysis software, secondary displays for glucose monitoring, insulin pump and other devices, and orthodontic and dental software.

Timeline for Registration of the Medical Devices

All the Class A -low-risk and Class B devices-moderate, low-risk must be registered with the CDSCO by August 2022, and all the moderate high-risk Class C and high-risk Class D devices have to be registered by August 2023. 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.

Learn more about Indian medical devices and IVD regulations

You can visit www.cliniexperts.com

References:

  1. Notice regarding classification of non-notified medical devices. Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ0OQ==Accessed on 27 th October, 2020.