Risk Classification of Medical Devices in Oncology

The field of oncology has witnessed remarkable advancements in medical technology, with innovative devices playing a pivotal role in cancer diagnosis, treatment, and management. To ensure the safety and efficacy of these devices, regulatory bodies like the Directorate General of Health Services (DGHS) and the Central Drugs Standard Control Organisation (CDSCO) in India have established guidelines for risk classification under the Medical Devices Rules, 2017. This blog delves into the recently published risk classification list of oncology-related medical devices, as outlined in the official notice dated January 2, 2026.

What is Risk Classification in Medical Devices?

Risk classification is a regulatory framework that categorizes medical devices based on their potential risks to patients and users. The classification ranges from Class A (low risk) to Class D (high risk), with Class D devices being the most critical as they are used in life-supporting or life-sustaining situations. This classification helps manufacturers, healthcare providers, and regulatory authorities ensure that medical devices meet stringent safety and performance standards.

Key Highlights of the Notice

The DGHS and CDSCO have released a detailed list of oncology-related medical devices, categorized by their intended use and risk classification. This list serves as a guideline for manufacturers and importers to comply with the Medical Devices Rules, 2017. It is important to note that the list is dynamic and subject to revisions as new technologies emerge and medical practices evolve.

Overview of Oncology Medical Devices and Their Risk Classifications

The notice provides a comprehensive list of 77 medical devices used in oncology, along with their intended uses and risk classifications. Below are some notable examples:

Class A Devices (Low Risk) 

Cervical Cone Knife, Single-Use: Used for excising abnormal tissue from the cervix during surgical procedures.
Cervical Cytology Scraper, Single-Use: Designed to collect cytological material from the cervix or vaginal area for cancer detection.
Telethermographic System: Measures temperature variations on the body surface using infrared radiation without skin contact.

Class B Devices (Moderate Risk) 

Balloon Kyphoplasty Kit: Used for minimally invasive procedures to treat vertebral compression fractures caused by trauma, cancer, or osteoporosis.
Bladder Instillation Buffer Solution: Creates an optimal environment for treating superficial bladder cancer with chemotherapy agents.
Flexible Fibreoptic Bronchoscope: Enables visual examination and treatment of the trachea, bronchi, and lungs, often used for biopsies and sampling.

Class C Devices (High Risk) 

Accelerator System Chair: Supports and positions patients during radiation therapy treatments.
Microwave Ablation System: Generates microwave energy for localized soft-tissue ablation to treat tumours and other conditions.
Intraoperative Tumour Margin Fluorescence Imaging System: Detects residual cancerous tissue during surgical procedures using fluorescent imaging.

Class D Devices (Highest Risk)

Alternating Electric Field Antimitotic Cancer Treatment System: Applies low-intensity electric fields to treat recurrent or newly diagnosed cancers, such as glioblastoma multiforme.
Coronary Artery Brachytherapy System Applicator: Delivers radiation therapy sources into coronary arteries to treat hypervascularized tumours.
Stereotactic Radiosurgery System for CNS: Uses precise gamma rays to treat brain tumours, upper spine lesions, and vascular abnormalities.

Importance of Risk Classification

The risk classification of medical devices is crucial for ensuring patient safety and effective treatment outcomes. Higher-risk devices undergo more rigorous testing and regulatory scrutiny to minimize potential hazards. For manufacturers, understanding the classification system is essential for compliance with regulatory requirements and for ensuring their devices meet the necessary safety standards.

Dynamic Nature of the List 

The notice emphasizes that the risk classification list is dynamic and subject to revisions. This adaptability allows the regulatory framework to keep pace with advancements in medical technology and evolving clinical practices. Manufacturers and healthcare providers must stay updated with the latest changes to ensure compliance and optimal patient care.

Conclusion

The risk classification list of oncology-related medical devices is a significant step toward standardizing the safety and efficacy of medical technologies in cancer care. By categorizing devices based on their intended use and associated risks, the DGHS and CDSCO aim to provide clear guidance to manufacturers and healthcare providers. This ensures that patients receive the highest standard of care while minimizing potential risks associated with medical devices.

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Source: CDSCO

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