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Dated: 03.04.2025

CDSCO Issues Updated Risk-Based Classification for Cardiovascular Medical Devices

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has released a significant draft notification updating the risk-based classification of cardiovascular medical devices. This update, effective from 1st April 2025, aligns with the provisions of the Medical Devices Rules, 2017, and seeks to ensure enhanced regulatory oversight and patient safety.

Objective of the Update

The revised classification list includes 351 cardiovascular devices, each assigned a risk class based on its intended use, level of invasiveness, and interaction with the cardiovascular system. This move aims to:

• Align Indian regulatory standards with global benchmarks.
• Facilitate clear regulatory pathways for manufacturers.
• Enhance safety and efficacy standards for medical devices.

Highlights of the Risk Classification

The classification is structured across four risk categories:

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

Examples from the list include:

• Class D: Aortic valve prostheses, Implantable pacemakers, Implantable cardioverter defibrillators, Cardiopulmonary bypass systems.
• Class C: Extracorporeal membrane oxygenation (ECMO) systems, Cardiac mapping systems, Cardiac monitors.
• Class B: Manual and digital sphygmomanometers, Home-use ECG monitors, Ambulatory blood pressure monitors.

Each device is listed with a unique serial number and assigned its appropriate risk classification.

Timeline and Implementation

• Effective Date: 1st April 2025
• The classification will apply to all cardiovascular medical devices imported, manufactured, or sold in India.

Stakeholder Engagement

CDSCO has invited feedback from stakeholders, including manufacturers, healthcare professionals, industry associations, and consumers.

• Comments and suggestions are to be submitted within 30 days from the date of the notification.
• A dedicated Google Form has been made available for this purpose: Submit Feedback Here

Implications for the Industry

• Manufacturers must ensure their devices are classified correctly and comply with applicable regulatory requirements.
• Devices falling under Class C and D will be subject to stricter conformity assessment procedures.
• The update promotes a more transparent, predictable, and safety-focused regulatory environment for cardiovascular devices.

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Source:CDSCO

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