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:

Class	Risk level	Licensing authority
Class A	Low risk	State Licensing Authority (SLA) for manufacture; CDSCO Form MD-15 for import
Class B	Low-to-medium risk	SLA for manufacture; CDSCO Form MD-14 for import
Class C	Medium-to-high risk	CDSCO for manufacture; CDSCO Form MD-14 for import
Class D	High risk	CDSCO 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, seek guidance from CDSCO or refer to IMDRF classification guidance.

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.