CDSCO License for Peripheral, Transluminal Angioplasty Catheter
Medical Device Information
Intended Use
A catheter for treating peripheral vascular diseases
Comprehensive Guide to CDSCO Licensing for Peripheral Transluminal Angioplasty Catheters (Class C)
Peripheral Transluminal Angioplasty Catheters are specialized medical devices designed for treating peripheral vascular diseases by restoring blood flow through minimally invasive procedures. Given their critical role in patient care and potential risks, these catheters fall under Class C risk classification as per the CDSCO regulations. Navigating the regulatory landscape for such devices can be complex, but with over 25 years of experience assisting 500+ companies, we offer you a detailed roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Peripheral Transluminal Angioplasty Catheters
The Central Drugs Standard Control Organization (CDSCO) governs the approval and regulation of medical devices in India. Peripheral Transluminal Angioplasty Catheters are notified under the Medical Device Rules, 2017, and specifically listed in the notification number 29/Misc/3/2017-DC (292) dated 06.06.2018. As a Class C device, the regulatory oversight is stringent, ensuring patient safety and device efficacy.
Risk Classification and License Requirements
According to the CDSCO classification framework, Peripheral Transluminal Angioplasty Catheters are classified as Class C devices due to their invasive nature and the significant risk involved in their use. This classification mandates:
- Manufacturing License: MD9 license (Application Form MD7) granted by the Central Licensing Authority.
- Import License: MD15 license (Application Form MD14) granted by the Central Licensing Authority.
These licenses require rigorous documentation, testing, and audits to ensure compliance.
Manufacturing License Process for Class C Devices (MD9)
- Test License (Form MD13): Before applying for the manufacturing license, you must obtain a test license for 1.5 to 2 months.
- Product Testing: Conduct product testing at CDSCO-approved laboratories to verify safety and performance.
- Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and others.
- License Application (Form MD7): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: The Central Licensing Authority will conduct an on-site audit.
- Query Resolution: Address any queries from CDSCO promptly.
- Grant of License (Form MD9): Upon successful review and audit.
For detailed guidance, refer to our MD9 License Guide.
Manufacturing License Documents Required
- Company Constitution and Certificate of Incorporation
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification of Technical Staff
- Fire and Pollution No-Objection Certificates (NOCs)
- Device Master File (DMF) – product specifications, design, and manufacturing process (Device Master File Guide)
- Plant Master File (PMF) – manufacturing facility details (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File compliant with ISO 14971 (Risk Management)
- Test Reports from CDSCO-approved labs (Testing Laboratories)
- Product Labels, Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certificates, SOPs)
Import License Process for Class C Devices (MD15)
- Document Preparation: Gather all mandatory documents including manufacturing license, free sale certificate, quality certifications, and device dossiers.
- License Application (Form MD14): Submit your import license application online through the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any department queries.
- Grant of License (Form MD15): Typically issued within 5-6 months.
For more insights, explore our Import License Guide.
Import License Documents Required
- Valid Manufacturing License (MD9) from the country of origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certificate
- CE Certificate or Regulatory Approval from Recognized Authority
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution and Address Proofs
Timeline and Processing Duration
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Manufacturing License (MD9) | 4 - 5 months total |
| Import License (MD15) | 5 - 6 months |
The entire manufacturing license process typically takes 4 to 5 months, including testing and audits, while import licenses require around 5 to 6 months.
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
MD15 Import License:
- For Class C devices: USD 3,000 per site + USD 1,500 per product
Additional costs include fees for product testing, audit charges, and consultancy if engaged.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing can prolong timelines.
- Solution: Engage CDSCO-approved testing laboratories early and prepare complete documentation to avoid back-and-forth.
Challenge: Non-compliance in audit findings.
- Solution: Conduct pre-audit internal reviews and ensure your Plant Master File and Quality Management System are audit-ready.
Challenge: Complex documentation requirements.
- Solution: Utilize expert regulatory consultants and refer to detailed guides like our MD9 License Guide for clarity.
Expert Consultation and Support
With over 25 years of experience and supporting more than 500 companies, we specialize in simplifying CDSCO licensing for Class C devices like Peripheral Transluminal Angioplasty Catheters. Our services include:
- Gap analysis and documentation support
- Liaison with CDSCO and notified bodies
- Assistance with product testing and audits
- Post-license compliance management
Contact us early in your product development cycle to streamline your regulatory journey.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device’s Class C status using the Medical Device Classification tool.
- Prepare Test License Application: Initiate the process by applying for the test license (Form MD13) on the CDSCO MD Online Portal.
- Engage Approved Testing Labs: Schedule product testing at certified laboratories.
- Compile Documentation: Assemble all regulatory documents, including DMF, PMF, risk management files, and quality certificates.
- Submit Manufacturing License Application: File Form MD7 for your MD9 license via the CDSCO portal.
- Prepare for Audit: Ensure your facility meets all regulatory requirements and conduct internal audits.
- Respond Promptly to Queries: Monitor application status and address departmental or audit queries efficiently.
Starting early and maintaining organized documentation are key to a smooth approval process. For personalized support, reach out to our expert team to guide you through each step with precision.
For additional resources and updates, visit the official CDSCO MD Online Portal and consult the list of notified bodies for audit requirements related to your device.
Embark on your regulatory journey with confidence and expert support to bring your Peripheral Transluminal Angioplasty Catheter to the Indian market efficiently and compliantly.
