CDSCO License for Cryosurgical set
Medical Device Information
Intended Use
A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions.
Comprehensive Guide to CDSCO Licensing for Cryosurgical Sets (Class C Medical Devices)
As seasoned regulatory consultants with over 25 years of expertise and having supported 500+ companies in navigating the Indian medical device regulatory landscape, we understand the critical importance of securing your CDSCO license efficiently and compliantly. This guide focuses on the Cryosurgical Set—a Class C oncology device used for targeted tissue freezing to destroy cancer cells—and provides a detailed roadmap for its manufacturing and import licensing under the CDSCO framework.
Understanding the Cryosurgical Set and Its Regulatory Importance
The Cryosurgical Set is a sterile, disposable device collection designed to work alongside cryosurgical units and monitoring tools to perform precision freezing of cancerous tissues. Given its direct use in oncological procedures and the inherent risks involved in tissue damage, the device is classified as Class C under the Indian medical device classification system. Regulatory compliance ensures patient safety, device efficacy, and market access in India’s rapidly growing healthcare sector.
CDSCO Regulatory Framework for Cryosurgical Sets
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Class C devices like the Cryosurgical Set fall under the Central Licensing Authority’s jurisdiction, requiring rigorous evaluation of quality, safety, and manufacturing processes.
Risk Classification and License Requirements for Class C Devices
Per the Medical Device Classification guideline, Class C devices present moderate to high risk and require:
- Manufacturing License (MD9 License): Issued by the CDSCO central authority.
- Import License (MD15 License): Also issued by CDSCO central authority for imported devices.
Both licenses involve comprehensive documentation, product testing, and audits.
Manufacturing License Process for Cryosurgical Sets (MD9)
- Test License (Form MD13): Mandatory initial step, allowing product testing; takes approximately 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved labs (Testing Laboratories) to validate safety and performance.
- Document Preparation: Assemble all technical and quality documents, including Device Master File and Plant Master File.
- Application Submission (Form MD7): Submit the MD9 manufacturing license application through the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: CDSCO conducts an on-site audit to verify compliance.
- Resolution of Queries: Address any observations or queries raised during audit.
- License Grant (Form MD9): Upon successful review, the manufacturing license is granted.
Total Timeline: Approximately 4 to 5 months
Manufacturing License Documents Required
- Company constitution documents
- Proof of premises ownership or lease agreement
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF) – see our Device Master File guide
- Plant Master File (PMF) – refer to our Plant Master File guide
- Essential Principles Checklist
- Risk Management File – critical for Class C devices (Risk Management)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation (ISO 13485:2016 compliance)
Import License Process for Cryosurgical Sets (MD15)
- Document Preparation: Unlike manufacturing, no test license is required; however, comprehensive documentation is essential.
- Application Submission (Form MD14): Submitted online via the CDSCO MD Online Portal.
- Queries Resolution: Respond promptly to any CDSCO queries.
- License Grant (Form MD15): After thorough assessment, import license is granted.
Total Timeline: Approximately 5 to 6 months
Import License Documents Required
- Valid Manufacturing License issued by the regulatory authority of the exporting country
- Free Sale Certificate proving market authorization in the country of origin
- ISO 13485:2016 Certificate
- CE Certificate (if available)
- Device Master File
- Plant Master File
- Wholesale License issued in India
- Company constitution documents
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 per product |
| MD15 Import | ₹3,000 per site (Class C/D) | ₹1,500 per product |
(Note: ₹ denotes Indian Rupees; fees are subject to revision by CDSCO.)
Common Challenges and Practical Solutions
- Delayed Test Reports: Coordinate early with CDSCO-approved labs to schedule testing; consult the official Testing Laboratories list.
- Incomplete Documentation: Utilize checklists and expert review to ensure all files like DMF, PMF, and Risk Management are comprehensive.
- Audit Non-Conformities: Pre-audit internal assessments can help identify gaps before CDSCO inspection.
- Regulatory Queries: Prepare clear, evidence-backed responses promptly to avoid processing delays.
Expert Consultation and Support
Navigating the regulatory process for Class C devices like the Cryosurgical Set requires meticulous attention to detail and up-to-date knowledge of CDSCO requirements. Our team has successfully guided numerous manufacturers and importers through MD9 and MD15 licensing, reducing timelines and minimizing rejection risks. We offer tailored consulting, document preparation, and audit readiness support.
Getting Started with Your CDSCO License Application for Cryosurgical Sets
- Assess Your Device Classification: Confirm Class C status and license requirements.
- Initiate Product Testing: Apply for a test license (MD13) promptly to avoid delays.
- Prepare Technical Dossiers: Develop detailed Device and Plant Master Files and implement a robust Risk Management system.
- Register on CDSCO MD Online Portal: Begin your application process at the official portal.
- Schedule Audits and Testing: Coordinate with notified bodies and approved labs early; consult the list of notified bodies.
- Engage Expert Consultants: Consider professional assistance for document review and regulatory strategy.
Taking these actionable steps ensures a smoother journey to obtaining your MD9 manufacturing and MD15 import licenses, enabling you to bring your Cryosurgical Set to the Indian market confidently and compliantly.
