CDSCO Releases Final Risk Classification List for Oncology Medical Devices

The final list places 77 oncology medical devices across four risk classes.

The Central Drugs Standard Control Organisation (CDSCO) has released the final risk classification list for medical devices used in oncology, formally categorising cancer-related technologies under the Medical Devices Rules, 2017, to define regulatory oversight for manufacturing and import approvals.

CDSCO has notified the classification through Appendix A, exercising its powers under sub-rule (3) of Rule 4 of the Medical Devices Rules, 2017.

India regulates medical devices through a risk-based framework aligned with global regulatory practices, where products are categorised from low to high risk depending on their intended use, invasiveness and potential impact on patient safety.

Until recent years, several oncology-focused medical devices lacked explicit classification, resulting in regulatory ambiguity for manufacturers, importers and innovators in digital health and advanced cancer care.

The final list places 77 oncology medical devices across four risk classes.

Low-risk Class A includes simple surgical consumables such as single-use cervical cytology scrapers and cervical cone knives, as well as extracorporeal hyperthermia system applicators used externally.

Class B devices, considered low to moderate risk, cover diagnostic and supportive tools such as breast transilluminators, flexible video bronchoscopes, scalp cooling systems to reduce chemotherapy-induced hair loss, and balloon kyphoplasty kits for cancer-related vertebral fractures.

A significant portion of modern oncology technologies falls under Class C, reflecting moderate to high risk. This category includes active therapeutic systems, implantable devices and software-driven solutions. Notably, computer vision and machine learning-aided cancer detection software is explicitly regulated as Software as a Medical Device, reflecting the growing role of digital health and AI in oncology diagnostics. Other Class C devices include microwave and cryoablation systems, electroporation therapy systems, robotic guidance platforms, linear accelerator quality assurance devices, implantable vascular ports and polymer-metal oesophageal stents.

Class D, the highest risk category, is reserved for life-sustaining and high-intensity therapeutic technologies. These include stereotactic radiosurgery systems for central nervous system tumours, alternating electric field antimitotic cancer treatment systems used in conditions such as glioblastoma, brachytherapy source spacers, and embolization particles designed to block tumour blood supply.

CDSCO has clarified that the intended use mentioned against each medical device is for guidance to applicants seeking manufacturing or import licences, while manufacturers may specify their own intended use as per regulatory provisions.

The regulator also emphasised that the oncology medical devices list is dynamic and will be revised periodically to reflect technological advances and evolving clinical practices.

By finalising the oncology device classification, CDSCO is expected to reduce uncertainty in regulatory submissions, streamline approval timelines and strengthen patient safety through proportionate oversight.

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