CDSCO Risk Classification of Oncology Medical Devices: Complete Regulatory Overview

CDSCO Risk Classification of Oncology Medical Devices: Complete Regulatory Overview

Introduction 

The Central Drugs Standard Control Organisation (CDSCO) has issued an important public notice on the risk classification of medical devices pertaining to oncology. This notification plays a crucial role in strengthening India’s regulatory framework for oncology medical devices, ensuring patient safety, regulatory clarity, and compliance under the Medical Devices Rules, 2017.

The classification is based on a risk-based approach, categorizing oncology devices into Class A, Class B, Class C, and Class D depending on their intended use, invasiveness, and potential risk to patients.

What is Risk Classification of Medical Devices?

Risk classification of medical devices refers to the systematic categorization of devices based on the level of risk they pose to patients and users. As per CDSCO guidelines, medical devices are classified into four categories:

• Class A – Low Risk
• Class B – Low to Moderate Risk
• Class C – Moderate to High Risk
• Class D – High Risk

This risk classification system determines the regulatory requirements for manufacturing, import, registration, and post-market surveillance of medical devices in India.

CDSCO Oncology Medical Devices Covered Under the Notification

The CDSCO public notice provides a comprehensive list of oncology medical devices used in cancer diagnosis, treatment, and management. These devices include:

• Cancer diagnostic devices
• Radiation therapy medical devices
• Brachytherapy systems
• Hyperthermia therapy systems
• Microwave and radiofrequency ablation systems
• Oncology imaging systems
• Implantable oncology devices

Each device has been classified based on its intended medical purpose and associated risk.

High-Risk Oncology Medical Devices (Class C and Class D)

Most oncology medical devices fall under Class C and Class D, as they are directly involved in cancer treatment and invasive procedures.

Examples of Class C Oncology Medical Devices:

• Microwave ablation system
• Electroporation therapy system
• Implantable vascular ports
• Radiation therapy digital imagers

Hyperthermia therapy systems

Examples of Class D Oncology Medical Devices:

• Alternating electric field antimitotic cancer treatment systems
• Brachytherapy source spacers
• Embolization particles
• Stereotactic radiosurgery systems

These high-risk oncology devices require strict regulatory oversight, clinical evaluation, and approval from CDSCO before manufacturing or import.

You may also refer to our CDSCO & Medical Devices regulatory articles for additional guidance on compliance and approvals.

Impact on Manufacturers and Importers

The CDSCO risk classification of oncology medical devices has a significant impact on manufacturers, importers, and distributors:

• Mandatory CDSCO registration for oncology medical devices
• Compliance with Medical Devices Rules, 2017
• Additional documentation for Class C and Class D devices
• Clinical investigation and performance evaluation requirements
• Post-market surveillance and vigilance obligations

Manufacturers dealing with oncology medical devices in India must ensure full regulatory compliance to avoid legal and commercial risks.

Regulatory Importance of Oncology Device Classification

The classification of cancer treatment devices enhances transparency and standardization in the Indian medical device ecosystem. It helps:

• Improve patient safety
• Ensure quality and efficacy of oncology devices
• Streamline regulatory approvals
• Align Indian regulations with global best practices

This CDSCO notification also supports innovation while maintaining strict control over high-risk medical devices used in oncology.

Conclusion

The CDSCO public notice on risk classification of medical devices pertaining to oncology is a major regulatory milestone for India’s healthcare and medical device sector. By clearly defining the risk categories of oncology devices, CDSCO has provided regulatory clarity to stakeholders while reinforcing patient safety.

Manufacturers, importers, and healthcare providers involved in oncology medical devices must carefully review the classification and ensure compliance with applicable rules and guidelines under Indian medical device regulations.  

Click here to Access the official guidance document

Note:
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