CDSCO License for Balloon kyphoplasty kit
Medical Device Information
Intended Use
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty.
Comprehensive Guide to CDSCO Licensing for Balloon Kyphoplasty Kit (Class C Medical Device)
Balloon kyphoplasty kits are specialized sterile surgical instruments designed specifically for the reduction of vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis. These kits play a critical role in minimally invasive oncology procedures, offering pain relief and spinal stabilization. Given their complexity and high-risk nature, Balloon Kyphoplasty Kits fall under Class C medical devices according to CDSCO classification and require stringent regulatory approvals before entering the Indian market.
With over 25 years of expertise and having assisted 500+ companies in securing CDSCO licenses, we present a detailed, actionable roadmap to navigate the regulatory framework for manufacturing and importing Balloon Kyphoplasty Kits in India.
CDSCO Regulatory Framework for Balloon Kyphoplasty Kits
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. As a Class C device, the Balloon Kyphoplasty Kit is subject to central licensing authority oversight. Compliance with the Medical Device Rules, 2017, and adherence to notified standards are mandatory.
Our team ensures your application aligns with the Notification File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, which categorizes and governs oncology-related devices like this kit.
Risk Classification and License Requirements
Balloon Kyphoplasty Kits are classified as Class C devices due to their invasive nature and critical use in oncology. This classification mandates obtaining an MD9 Manufacturing License for domestic production and an MD15 Import License for importing finished products.
| License Type | Authority | Form Number | Processing Time | Fees (INR) |
|---|---|---|---|---|
| MD9 Manufacturing | Central Licensing | MD7 | 4-5 months | ₹50,000 + ₹1,000 per product |
| MD15 Import License | Central Licensing | MD14 | 5-6 months | ₹2,25,000 approx.* |
*Fees based on Class C device category (₹3000 per site + ₹1500 per product converted to INR)
Manufacturing License Process (MD9) for Balloon Kyphoplasty Kit
The MD9 license process involves multiple sequential steps:
- Test License (Form MD13): Obtain a test license allowing product testing, typically processed within 1.5 to 2 months.
- Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories (list of testing laboratories) to verify safety and efficacy.
- Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, QMS documentation, and product labeling.
- Application Submission: Submit the manufacturing license application via the CDSCO MD Online Portal using Form MD7.
- Audit by CDSCO Inspectors: The CDSCO conducts a facility audit to verify compliance with Good Manufacturing Practices (GMP) and QMS.
- Query Resolution: Address any observations or queries raised during audit or document review.
- License Grant: Upon successful compliance, the MD9 license is granted.
Manufacturing License Documents Required
- Company Constitution and Registration Proof
- Proof of Ownership/Lease of Manufacturing Premises
- List and Qualification Details of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- 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 — Align with Risk Management best practices
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents
Import License Process (MD15) for Balloon Kyphoplasty Kit
For importers intending to bring Balloon Kyphoplasty Kits into India, the MD15 license is required.
- Document Preparation: Compile all necessary documents including valid manufacturing licenses, Free Sale Certificates, CE Certificates, ISO 13485:2016 certification, and company details.
- Application Submission: Submit application on the CDSCO MD Online Portal using Form MD14.
- Review and Queries: CDSCO reviews the application and may raise clarifications.
- License Issuance: After satisfactory review, the import license (MD15) is issued.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License for distribution in India
- Company Constitution and Registration Proof
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| License Application Review | 1 - 1.5 months |
| Audit & Query Resolution | 1 - 1.5 months |
| Total Manufacturing License (MD9) | 4 - 5 months |
| Import License (MD15) | 5 - 6 months |
Government Fees and Costs
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- MD15 Import License: Approximately ₹2,25,000 (site and product fees combined for Class C devices)
- Test License (MD13): Fees included within manufacturing license application
Understanding these costs upfront helps manufacturers budget effectively and avoid delays due to incomplete payments.
Common Challenges and Solutions
Challenge: Delays in test report issuance due to limited availability of CDSCO-approved labs.
Solution: Early engagement with notified labs (list here) and pre-booking slots can mitigate delays.
Challenge: Audit non-compliance due to incomplete QMS documentation.
Solution: Adopt a robust Quality Management System aligned with ISO 13485:2016 and prepare detailed Plant and Device Master Files.
Challenge: Complex queries from CDSCO inspectors leading to prolonged review cycles.
Solution: Engage regulatory consultants experienced in responding to CDSCO queries promptly and comprehensively.
Expert Consultation and Support
With decades of regulatory experience, we specialize in guiding manufacturers and importers through the nuanced CDSCO licensing landscape. Our services include document preparation, audit readiness, test lab coordination, and query resolution to fast-track your application.
Getting Started with Your CDSCO License Application
- Assess Classification: Confirm Balloon Kyphoplasty Kit as Class C using CDSCO guidelines (Medical Device Classification).
- Prepare Documentation: Initiate preparation of Device Master File, Plant Master File, Risk Management, and QMS documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to begin product testing.
- Schedule Testing: Coordinate with CDSCO-approved labs to complete mandatory testing.
- Submit Manufacturing License Application: Once test reports are ready, file Form MD7 for MD9 license.
- Prepare for Audit: Ensure your manufacturing site complies with GMP and is ready for inspection.
- Track Application: Use the CDSCO portal to monitor status and respond promptly to queries.
For importers, begin with gathering all mandatory certificates and apply for the MD15 license via Form MD14.
Embarking on this journey with expert guidance ensures a smoother, faster approval process, enabling timely market access for your Balloon Kyphoplasty Kits in India.
For a detailed consultation tailored to your specific needs, contact our regulatory experts today and leverage our 25+ years of CDSCO licensing success.
References:
- Submit your application through the CDSCO MD Online Portal
- Check the list of notified bodies for audit requirements
- Explore our MD9 License Guide
- Understand Risk Management
- Learn more about Medical Device Classification
