Classification of Newly Notified Medical Devices

Revised Classification of Medical Equipment and IVDs: Key Updates

This document provides an updated classification of medical devices and in vitro diagnostics (IVDs), including the notified category, intended use, and risk class, aligned with the Medical Devices Rules, 2017.

Key Highlights

• Dynamic Classification
  • The classification list is dynamic and subject to periodic revisions to ensure alignment with evolving regulatory standards.
• Regulatory Framework
  • The safety, quality, and performance of medical devices are regulated under the Drugs and Cosmetics Act, 1940, and the associated rules.
• General Intended Use
  • The intended use of each device is outlined to assist importers and manufacturers in determining their regulatory needs.
• Separate Classification
  • Components, accessories, and companion in vitro diagnostics are classified separately to ensure clarity in regulatory categorization.
  • Certain devices may fall under dual-use categories.
• Specific Regulation for Glucometers
  • Glucometers will be regulated specifically under the IVD category, ensuring compliance with related safety and performance standards.

Additional Attachment

The document includes an attachment listing medical devices and IVDs, along with their respective risk classes, as per Rule 4 of the Medical Devices Rules, 2017.

This updated classification serves as a critical resource for stakeholders, enabling compliance with India’s regulatory framework for medical devices and diagnostics.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzMjU=
Region: India