CDSCO Class A Medical Devices: Updated List of 1,069 Devices

Meta Description: CDSCO Class A medical devices list updated to 1,069 low-risk devices; registration required via CDSCO Online System under MDR, 2017 guidelines

The Central Drugs Standard Control Organisation (CDSCO) has classified a total of 1,069 medical devices under the risk category of Class A (non-sterile and non-measuring). This expansion from the previous list of around 803 devices aims to clarify regulatory requirements related to registration and other compliance, benefiting both the regulator and industry stakeholders.

Registration Requirement for Class A Devices

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), stated that although these CDSCO Class A medical devices are exempted from licensing under the Medical Devices Rules, 2017, manufacturers or importers must obtain a registration number via the CDSCO Online System for Medical Devices. This falls under Chapter IIIB of the Medical Devices Rules, 2017.

Key Devices Included in the Updated List

The newly classified devices include reusable abdominal scissors, abdominal support belts, ENT and orthopedic surgical probes, acupressure devices, audiometric testing equipment, adhesive pads and strips, pressure relief cushions, adult incontinence pants, alcohol swabs, alternating-pressure bed mattresses, ambulance stretchers, anatomical models for surgical planning, birthing beds, cerebral palsy walkers, cervical pillows, and pediatric chair cushions, among others.

Intended Use Guidance for Manufacturers

The DCGI emphasized that the intended use listed for CDSCO Class A medical devices is for guidance. Manufacturers may specify a different intended use, provided it aligns with the intended purpose in the CDSCO risk classification list.

Dynamic List and Future Revisions

"This list is dynamic and subject to revision under the Medical Devices Rules, 2017," said Dr. Raghuvanshi. Variants with measuring functions or supplied in sterile form are excluded from this classification.

Draft Updates and Stakeholder Consultation

Earlier in January 2025, CDSCO released a draft update on the risk-based classification list. The draft sought stakeholder comments on additions across Interventional Radiology, Radiotherapy, Oncology, and Class A devices, reflecting a continuous effort to align domestic regulation with global standards.

Risk-Based Classification Under MDR, 2017

Under Rule 4 of Chapter II of the Medical Devices Rules, 2017, medical devices are classified based on risk:

• Class A: Low-risk devices
• Class B: Low-moderate risk
• Class C: Moderate-high risk
• Class D: High-risk

This classification also applies to in vitro diagnostic devices, ensuring a systematic risk-based regulatory framework.

Role of the Central Licensing Authority

The Central Licensing Authority (CLA) has the power to classify medical devices based on intended use and other parameters. It can also add or remove devices from lists or modify their classification, supporting regulatory flexibility.

Strengthening Regulatory Oversight

The classification of CDSCO Class A medical devices enables better regulatory control, licensing, and compliance, while promoting international standards. Since all medical devices were notified under MDR, 2017 in February 2020, this update further strengthens regulation in India’s growing medical device sector.