The Central Drugs Standard Control Organisation (CDSCO) has released its final risk classification list for medical devices used in oncology, providing regulatory clarity for cancer-related medical technologies in India.
Issued under the Medical Devices Rules, 2017, the classification categorises oncology devices based on their intended use and associated risk, determining the level of regulatory oversight required for manufacturing, import and marketing approvals. The move is expected to streamline compliance pathways for manufacturers and reduce ambiguity in regulatory submissions.
The final list covers a wide range of oncology medical devices, including diagnostic, therapeutic and supportive technologies, and assigns them across the four established risk classes—Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk).
Cervical cone knife, single-use – Instrument used for excision of abnormal cervical tissue
Cervical cytology scraper, single-use – Device for collecting cytological material from cervix or vagina
Extravascular-circulation hyperthermia system applicator, extracorporeal – External applicator for delivering heated fluids during hyperthermia treatment
Accelerator system chair – Patient positioning support used during radiation therapy
Accelerator system quality assurance device – Calibration and performance verification of radiation accelerators
Alternating electric field antimitotic cancer treatment system generator – Battery-powered generator producing intermediate-frequency electric current
Anorectal brachytherapy system applicator, remote-afterloading – Remote afterloading applicator for rectal and anal cancer treatment
Anorectal brachytherapy system applicator, manual – Manual applicator for rectal and anal brachytherapy
Brachytherapy system remote-afterloading operator console – Control console for brachytherapy systems
Breast 3-D infrared imaging/vascular analysis system – Imaging system for breast cancer risk assessment
Breast brachytherapy system applicator, remote-afterloading – Single-use applicator for breast radiotherapy
Breast ultrasound imaging system, intracorporeal – Intracorporeal ultrasound imaging of the breast
Capsular tension ring – Device to stabilise subluxated crystalline lens capsules
Computer vision / machine learning-aided cancer detection software – Software analysing radiological images for cancer detection
Cryosurgical set / cryoablation system – System for freezing and destroying cancerous tissue
Electrocancer therapy system – Uses low-voltage direct current to treat tumours
Electroporation therapy system – Facilitates delivery of therapeutic agents using electrical impulses
Electroporation therapy system endoscopic applicator – Endoscopic component of electroporation therapy
Facial prosthesis – Artificial replacement of facial structures
Fixed-aperture therapeutic X-ray system collimator – Controls radiation exposure during therapy
Mechanical infusion pump, reusable – Non-electric reusable infusion pump
Mechanical infusion pump, single-use – Disposable non-electric infusion pump
Hyperthermia system temperature probe – Measures tissue temperature during hyperthermia therapy
Implantable vascular port/catheter – Provides long-term vascular access for chemotherapy
Alternating electric field antimitotic cancer treatment system – Applies electric fields to inhibit cancer cell division
Alternating electric field antimitotic cancer treatment system transducer array – Head-worn array converting current into electric fields
Brachytherapy source spacer – Bioabsorbable spacer used between radioactive seeds
Coronary artery brachytherapy system applicator, manual-afterloading – Delivers radiation sources into coronary arteries
Embolization particle, bioabsorbable – Temporarily occludes tumour-feeding blood vessels
Embolization particle, non-bioabsorbable – Permanently blocks blood supply to tumours
Devices placed in higher-risk categories will be subject to more stringent regulatory requirements, while lower-risk products will follow simplified approval processes.
The finalisation of the oncology risk classification follows earlier draft notifications and stakeholder consultations, addressing long-standing industry demand for clearer regulatory guidance in cancer-related medical devices.
CDSCO indicated that the oncology device classification may be updated periodically to reflect technological advancements and evolving clinical practices, in line with the framework of the Medical Devices Rules.
The development forms part of the regulator’s broader efforts to strengthen India’s medical devices ecosystem through risk-based regulation, improved patient safety and clearer market access pathways for oncology-focused medtech innovation.
