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By Device Type

This page indexes CDSCO guidance documents and requirements organized by medical device type, including device-specific classification, GMP, clinical investigation, and quality standards.

Official sources: CDSCO; SUGAM portal; Bureau of Indian Standards; IMDRF

By Device Type Overview

By Device Type Overview

Purpose: This section organizes CDSCO guidance, requirements, and standards by medical device category to help applicants quickly locate relevant regulatory documents for their specific device.

How to use:

  1. Locate your device category (e.g., In Vitro Diagnostics, Cardiovascular Devices, Orthopedic Devices, etc.)
  2. Review classification and risk-based requirements
  3. Identify applicable clinical investigation or quality standards
  4. Check for device-specific guidance documents or office memoranda
  5. Cross-reference with BIS standards and IMDRF guidance if adopted

Device categories typically covered:

  • In Vitro Diagnostics (IVDs)
  • Cardiovascular Devices
  • Orthopedic Devices
  • Dental Devices
  • Ophthalmic Devices
  • Wound Care Devices
  • (Additional categories as needed)

Official resources: CDSCO; SUGAM portal; Bureau of Indian Standards; IMDRF