New Delhi: In a significant step toward streamlining India's medical device regulatory ecosystem, the Central Drugs Standard Control Organisation (CDSCO) has introduced a new Risk Classification Module on its online portal to simplify the approval process for medical devices other than in-vitro diagnostics (IVD).

According to the circular issued by the Ministry of Health and Family Welfare, Directorate General of Health Services, the new module has been made functional on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in) effective November 27, 2025.

The notice stated,

"In order to simplify the regulatory approval procedures and ease the process of risk classification of medical devices other than In-vitro Diagnostic (IVD) medical devices, a new Risk Classificati

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