Skip to main content

How Classification Works

Risk-based, IMDRF-aligned​

India's Medical Devices Rules 2017 adopts a four-class, risk-based classification system aligned with the IMDRF Global Harmonization Task Force (GHTF) principles:

ClassRisk levelLicensing authority
Class ALow riskState Licensing Authority (SLA) for manufacture; (self-declaration / registration) (no CDSCO approval required) Form MD-15 for import
Class BLow-to-medium riskSLA for manufacture; CDSCO Form MD-14 for import
Class CMedium-to-high riskCDSCO for manufacture; CDSCO Form MD-14 for import
Class DHigh riskCDSCO for manufacture; CDSCO Form MD-14 for import

Classification criteria (Rule 4 & Schedule of MDR 2017)​

Classification is based on:

  • Duration of contact with the body (temporary, short-term, long-term);
  • Invasiveness (non-invasive, invasive, implantable);
  • Active vs non-active (powered or non-powered);
  • Intended purpose and body system affected;
  • Potential risk to the patient and user.

How to classify your device​

  1. Identify whether the device is listed in Schedule I (medical devices) or Schedule II (IVDs);
  2. Review the classification criteria in Rule 4 and the applicable Schedule;
  3. Apply the classification rules to the intended use and technical characteristics;
  4. If borderline or ambiguous, submit a pre-submission inquiry (PSI) to CDSCO with device description, intended use, and technical specifications before full development. You may also refer to published IMDRF classification guidance documents and precedent classifications available on the CDSCO website.

IVDs have a separate classification track​

In vitro diagnostics listed in Schedule II follow distinct classification rules based on their risk to individual patients and public health. See IVD Classification.

Software and SaMD​

Software as a Medical Device (SaMD) is classified using the IMDRF SaMD classification framework, adapted for the Indian context. See SaMD Classification.

Note on State Licensing Authorities (SLA) Manufacturing licenses for Class A and B devices are issued by State Licensing Authorities designated by individual state governments. Manufacturers must apply through their respective state health department or state drug licensing authority. There is no centralized CDSCO application for Class A and B manufacturing licenses.