Medical Device License for Oncology Devices
Oncology devices are advanced medical instruments designed for the diagnosis, treatment, and monitoring of cancer. These devices include radiation therapy equipment, diagnostic imaging systems, and therapeutic devices that play a crucial role in cancer care.
The Central Drugs Standard Control Organization (CDSCO) regulates all oncology devices under the Medical Device Rules, 2017. Whether you manufacture or import, obtaining the correct CDSCO license is mandatory for legal market access, patient safety, and product credibility.
With over 25 years of experience and 500+ successful licenses, our team guides you through every regulatory step—ensuring your oncology devices meet the highest standards of safety, quality, and compliance.

Key CDSCO Licenses for Oncology Devices

MD5 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- Audit by Notified Body

MD9 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- CDSCO Audit

MD15 Import License
- Dossier Preparation
- Foreign Certificates
- Application Submission
- CDSCO Review
All Articles on Oncology Devices
CDSCO License for Anorectal brachytherapy system applicator, manual
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Anorectal Brachytherapy System Applicators, with timelines, costs, and document checklists.
CDSCO License for Blood photochemical treatment agent
Expert guidance on obtaining CDSCO MD9 license for Class C Blood Photochemical Treatment Agents, covering timelines, costs, documentation, and practical steps for smooth market entry.
CDSCO License for Externally-propelled flexible video colonoscope
Expert guidance on obtaining CDSCO MD5 manufacturing and MD15 import licenses for flexible video colonoscopes (Class B), including timelines, costs, and document requirements.
CDSCO License for General-purpose infusion pump, mechanical, single-use
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C general-purpose mechanical infusion pumps, including timelines, costs, and document requirements.
CDSCO License for Alternating electric field antimitotic cancer treatment system
Expert guide on securing CDSCO MD9 license for Class D oncology devices like the Alternating Electric Field Antimitotic Cancer Treatment System with detailed timelines, docs, and costs.
CDSCO License for Alternating electric field antimitotic cancer treatment system generator
Navigate the CDSCO approval process for your Class C alternating electric field antimitotic cancer treatment system with expert timelines, costs, and documentation guidance.
CDSCO License for Electro cancer therapy system
Navigate the CDSCO MD9 licensing process for your Class C Electro Cancer Therapy System with expert guidance on timelines, documents, costs, and practical tips for smooth regulatory approval.
CDSCO License for Flexible fibre optic mediastinoscope
Expert guidance on obtaining CDSCO MD9 license for Flexible Fibre Optic Mediastinoscope (Class C) with detailed timelines, costs, documents, and practical tips.
CDSCO License for Accelerator system chair
Expert guidance on obtaining CDSCO MD9 manufacturing & MD15 import licenses for Accelerator System Chair (Class C oncology device) with detailed timelines, costs, and document requirements.
CDSCO License for Brachytherapy system remote-afterloading operator console
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Brachytherapy System Remote-Afterloading Operator Consoles, with timelines, costs, and document checklists.
CDSCO License for General-purpose infusion pump, mechanical, reusable
Expert guidance on obtaining CDSCO MD9 license for Class C reusable mechanical infusion pumps, covering timelines, costs, document requirements, and practical tips for smooth approval.
CDSCO License for Electroporation therapy system endoscopic applicator
Navigate the CDSCO licensing process for your Class C Electroporation Therapy System Endoscopic Applicator with expert guidance on timelines, costs, and documentation.
CDSCO License for Extravascular-circulation hyperthermia system
Navigate the CDSCO licensing process for your Class B Extravascular-circulation hyperthermia system with expert insights on timelines, costs, and documentation.
CDSCO License for Flexible fibre optic bronchoscope
Get expert guidance on obtaining a CDSCO MD5 manufacturing license for your flexible fibre optic bronchoscope. Complete process, timelines, costs, and document checklist included.
CDSCO License for Cervical cytology scraper, reusable
Expert guidance on obtaining CDSCO MD5 manufacturing license for reusable cervical cytology scrapers, including timelines, costs, and document insights for Class A oncology devices.
CDSCO License for Alternating electric field antimitotic cancer treatment system transducer array
Expert guidance on securing CDSCO MD9 license for Class C oncology devices like alternating electric field antimitotic cancer treatment systems, including timelines, costs, and document requirements.
CDSCO License for Antimicrobial postsurgical brassiere
Get expert guidance on obtaining your CDSCO MD5 manufacturing license for Antimicrobial Postsurgical Brasieres (Class A). Learn timelines, costs, documents, and practical steps.
CDSCO License for Breast ultrasound imaging system
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Breast Ultrasound Imaging Systems, with detailed timelines, costs, and document requirements.
CDSCO License for Extravascular-circulation hyperthermia system applicator, extracorporeal
Expert guidance on obtaining CDSCO MD5 manufacturing license for Class A Extravascular-Circulation Hyperthermia System Applicator, including timelines, costs, and documentation.
CDSCO License for Antimicrobial postsurgical female underpants
Expert guidance on obtaining CDSCO MD5 manufacturing license for Class A antimicrobial postsurgical female underpants with timelines, costs, and document essentials.
CDSCO License for Bladder instillation buffer solution
Expert guidance on obtaining CDSCO MD5 manufacturing and MD15 import licenses for Class B bladder instillation buffer solutions, including timelines, costs, and document insights.
CDSCO License for Coronary artery brachytherapy system applicator, manual- afterloading
Expert guidance on obtaining CDSCO MD9 license for Class D Coronary Artery Brachytherapy System Applicator with timelines, costs, documentation, and practical tips.
CDSCO License for FerriScan R2-MRI Analysis System
Expert guidance on obtaining CDSCO MD9 license for FerriScan R2-MRI Analysis System, a Class C oncology device, including timelines, costs, documents, and practical tips to ensure smooth approval.
CDSCO License for Breast transilluminator
Expert guidance on securing CDSCO MD5 license for Breast Transilluminator Class A device with detailed timelines, costs, and documentation to ensure smooth regulatory approval in India.
CDSCO License for Anorectal brachytherapy system applicator, remote-afterloading
Expert guidance on obtaining CDSCO MD9 license for Class C Anorectal Brachytherapy System Applicator with detailed timelines, costs, and document requirements.
CDSCO License for Cervical cone knife
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Cervical Cone Knife, with timelines, costs, and document checklists.
CDSCO License for Balloon kyphoplasty kit
Expert guide to obtaining CDSCO MD9 manufacturing and import licenses for Balloon Kyphoplasty Kits with timelines, costs, and document checklists.
CDSCO License for Accelerator system quality assurance device
Expert guidance on obtaining CDSCO MD9 license for Accelerator System Quality Assurance Device, including timelines, costs, and detailed documentation for Class C oncology devices.
CDSCO License for Cryosurgical set
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Cryosurgical Sets (Class C), including timelines, costs, document checklists, and practical tips.
CDSCO License for Electronic clinical breast examination system
Expert guide to obtaining CDSCO MD5 license for Electronic Clinical Breast Examination Systems—detailed timelines, costs, documents, and practical steps for Class B oncology devices.
CDSCO License for Electroporation therapy system
Expert guide to obtaining CDSCO MD9 license for Electroporation Therapy Systems (Class C) in India with detailed timelines, costs, documents, and practical tips.
CDSCO License for Brachytherapy radionuclide phantom, test object
Expert guidance on obtaining CDSCO MD5 license for Class A Brachytherapy radionuclide phantom, including timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Breast 3-D infrared imaging/vascular analysis system
Expert guide to obtaining CDSCO MD9 license for Breast 3-D infrared imaging/vascular analysis system with timelines, costs, documents, and practical tips.
CDSCO License for Brachytherapy source spacer
Expert guidance on CDSCO MD9 license for Class C Brachytherapy Source Spacer, covering timelines, costs, documents, and practical steps for smooth regulatory approval in India.
CDSCO License for Colonic cytology sampling set
Navigate the CDSCO licensing process for your Class B Colonic Cytology Sampling Set with expert guidance on timelines, costs, and documentation to ensure smooth market entry.
CDSCO License for Facial prosthesis
Expert guidance on obtaining CDSCO MD5 License for Facial Prosthesis (Class B) with detailed steps, timelines, costs, and document requirements tailored for oncology device manufacturers.
CDSCO License for Breast brachytherapy system applicator, remote-afterloading
Expert guidance on obtaining CDSCO MD9 license for Breast Brachytherapy System Applicators, detailing timelines, costs, document requirements, and practical tips for smooth approval.
CDSCO License for Endocervical aspirator
Expert guidance on obtaining CDSCO MD9 license for Class C Endocervical Aspirators with timelines, costs, and documentation for smooth market entry in India.
CDSCO License for Fixed-aperture therapeutic x-ray system collimator
Navigate the CDSCO licensing process for your Class C Fixed-aperture therapeutic x-ray system collimator with expert guidance on timelines, costs, and documentation.
CDSCO License for Breast binder
Navigate the CDSCO licensing process for Breast Binders (Class A) with expert guidance on documentation, timelines, costs, and regulatory compliance tailored for oncology device manufacturers.
CDSCO License for Flexible video bronchoscope, reusable
Comprehensive guide on obtaining CDSCO MD5 manufacturing license for reusable flexible video bronchoscopes, with detailed timelines, costs, and expert regulatory insights.
CDSCO License for Robotic Guidance system for image Guided procedures
Expert guidance on obtaining CDSCO MD5 license for Robotic Guidance Systems in oncology, covering timelines, costs, documentation, and practical steps to ensure regulatory compliance in India.
CDSCO License for Cytotoxic waste receptacle
Expert guidance on obtaining CDSCO MD5 license for Cytotoxic Waste Receptacles (Class A), covering timelines, costs, documents, and practical tips for smooth market entry.
CDSCO License for Cervical cytology scraper, single-use
Expert guidance on obtaining CDSCO MD5 license for Cervical Cytology Scraper, Class B medical device, including timelines, costs, and document requirements.
CDSCO License for Capsular tension ring
Expert guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Capsular Tension Rings, covering timelines, costs, documents, and practical tips.