Sep 9, 2020

Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements.

According to Emergo by UL consultants in New Delhi and Hyderabad, the two new notices cover proposed classifications of 24 medical device categories as well as three categories for IVDs.

Medical device classifications

Among the 24 medical device classifications, CDSCO has included software as a category for the first time. 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.

IVD classifications

CDSCO has proposed three broad IVD classification categories: IVD analyzers (53 individual IVD types), IVD instruments (18 device types), and IVD software (nine device types).

Although the notice does provide regulatory clarity for devices heretofore non-notified to Indian regulations, for IVDs in particular these proposals would introduce significant new compliance requirements for market access.

CDSCO will begin accepting comments from manufacturers and other stakeholders in early October 2020.

Learn more about medical device and IVD regulations in India:

 

Author

  • Stewart Eisenhart

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