The Risk Classification of Medical Devices in Interventional Radiology

The medical device industry plays a crucial role in advancing healthcare by providing innovative tools and technologies for diagnosis, treatment, and patient care. In India, the Central Drugs Standard Control Organisation (CDSCO) oversees the regulation of medical devices to ensure their safety, efficacy, and quality. Recently, the Directorate General of Health Services issued a notice regarding the risk classification of medical devices pertaining to interventional radiology under the Medical Devices Rules, 2017. This blog aims to provide a detailed overview of the classification system, its significance, and the implications for stakeholders.

What is Risk Classification of Medical Devices?

Risk classification is a systematic approach to categorizing medical devices based on their intended use and potential risks to patients and users. The classification helps regulatory authorities ensure that devices meet safety and performance standards before they are manufactured, imported, or used in medical practice. In India, the Medical Devices Rules, 2017, provide the framework for this classification.

The Recent Notice by CDSCO 

On November 26, 2025, the Directorate General of Health Services issued a notice to classify medical devices related to interventional radiology. This classification is based on the risk associated with the devices and their intended use. The notice emphasizes that the list is dynamic and subject to revision under the provisions of the Medical Devices Rules, 2017. The classification is intended to guide applicants who wish to manufacture or import these devices in India.

Risk Classes for Medical Devices 

The risk classification system categorizes medical devices into four classes based on their level of risk:

Class A (Low Risk): Devices with minimal risk to patients and users.
Class B (Low to Moderate Risk): Devices with slightly higher risk but still considered safe with proper use.
Class C (Moderate to High Risk): Devices with significant risk that require stringent regulatory oversight.
Class D (High Risk): Devices with the highest risk, often used in critical or life-supporting applications.

Key Highlights from the Classification List

The notice includes a detailed list of 183 medical devices used in interventional radiology, along with their intended use and risk classification. Here are some notable examples:

Angiographic X-ray System (Class C): Used for radiologic visualization of the heart, blood vessels, or lymphatic system during or after the injection of a contrast medium.
Bone Densitometer (Class C): Measures bone density and mineral content using x-ray or gamma ray transmission.
Cardiovascular MRI System (Class C): Visualizes the cardiovascular system using magnetic resonance imaging.
Ultrasound Imaging System Application Software (Class B): Adds specific image processing and analysis capabilities to diagnostic ultrasound systems.
Coronary Optical Coherence Tomography System Catheter (Class D): A sterile flexible tube used for high-resolution imaging of coronary intravasculature during interventional procedures.

The list also includes devices for dental imaging, nuclear medicine, ultrasound systems, and more, each categorized based on their risk level.

Implications for Stakeholders 

The risk classification list serves as a guide for manufacturers, importers, and healthcare providers. Here’s how it impacts various stakeholders:

Manufacturers and Importers: Companies intending to manufacture or import medical devices must adhere to the classification guidelines and ensure compliance with the Medical Devices Rules, 2017. This includes obtaining necessary approvals and certifications based on the risk class of the device.
Healthcare Providers: Hospitals and clinics can use the classification to better understand the safety and intended use of medical devices, ensuring they select the right tools for patient care.
Regulatory Authorities: The classification helps streamline the approval process and ensures that high-risk devices undergo rigorous evaluation before being introduced to the market.

Dynamic Nature of the Classification List 

It is important to note that the risk classification list is dynamic and subject to periodic revisions. This ensures that the list remains up-to-date with advancements in medical technology and addresses emerging risks. Stakeholders are encouraged to stay informed about updates to the list, which will be published on the CDSCO website.

Conclusion

The risk classification of medical devices in interventional radiology is a significant step toward ensuring patient safety and improving healthcare standards in India. By categorizing devices based on their risk levels, the CDSCO aims to provide clear guidelines for manufacturers, importers, and healthcare providers. As the list evolves, it will continue to play a vital role in regulating medical devices and fostering innovation in the healthcare sector.

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Source: CDSCO

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