CDSCO License for Diagnostic Radiology Catheters
Medical Device Information
Intended Use
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Comprehensive Guide to CDSCO Licensing for Diagnostic Radiology Catheters (Class C)
Diagnostic Radiology Catheters are vital medical devices used specifically for delivering radiopaque media during angiography procedures. As Class C devices under the CDSCO framework, these catheters require rigorous regulatory compliance to ensure safety and efficacy in the Indian market. With over 25 years of experience assisting more than 500 companies, we understand the nuances involved in obtaining your CDSCO license promptly and efficiently.
CDSCO Regulatory Framework for Diagnostic Radiology Catheters
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Diagnostic Radiology Catheters fall under the category of Catheters and are notified under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. The regulatory framework mandates that manufacturers and importers secure the appropriate licenses before marketing these devices.
Due to their intermediate risk profile, Diagnostic Radiology Catheters are classified as Class C devices, which means they require a manufacturing license from the Central Licensing Authority (CLA) in the form of an MD9 license.
Risk Classification and License Requirements for Class C Catheters
Class C devices like Diagnostic Radiology Catheters are considered moderate to high-risk devices. This classification dictates the regulatory pathway:
- License Type: MD9 Manufacturing License (Application Form MD7)
- Authority: Central Licensing Authority (CDSCO HQ)
- Process Duration: Approximately 4 to 5 months
- Cost Components: Rs 50,000 per application + Rs 1,000 per product
For importers, an Import License (MD15) from CDSCO is mandatory before market entry.
Manufacturing License Process (MD9) for Diagnostic Radiology Catheters
The MD9 license process is comprehensive and involves multiple steps:
- Test License (Form MD13): Before applying for the MD9 license, companies must secure a Test License to conduct product testing. This step takes about 1.5 to 2 months.
- Product Testing: Diagnostic Radiology Catheters must be tested at CDSCO-approved laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories for authorized centers.
- Document Preparation and Submission: After successful testing, the application for the MD9 license (Form MD7) can be submitted through the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO inspectors will conduct a thorough audit of the manufacturing facility, quality management system, and documentation.
- Query Resolution: Any queries raised by CDSCO during the inspection or document review must be addressed promptly.
- License Grant: Upon satisfactory completion of all steps, the MD9 license (Form MD9) is granted.
Manufacturing License Documents Required for MD9
Preparing a complete dossier is crucial to avoid delays. Essential documents include:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control Board Clearance
- Device Master File detailing design, manufacturing processes, and specifications (Device Master File Guide)
- Plant Master File describing the manufacturing facility and quality assurance processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File in line with ISO 14971 standards (Risk Management)
- Product Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System documentation, typically ISO 13485:2016 certification
Import License Process (MD15) for Diagnostic Radiology Catheters
If you plan to import Diagnostic Radiology Catheters into India, obtaining the MD15 import license is mandatory. The process involves:
- Detailed document submission including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and Wholesale License.
- Application submission on the CDSCO MD Online Portal.
- Review and query resolution by CDSCO.
- License issuance within approximately 5 to 6 months.
Documents Required for Import License (MD15)
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| MD9 License Application | 1 month (including audit and queries) |
| Total Duration | Approximately 4 to 5 months |
For import licenses (MD15), the timeline is generally 5 to 6 months.
Government Fees and Costs
- MD9 License Application Fee: Rs 50,000 per application
- Product Fee: Rs 1,000 per product
Additional costs may include:
- Product testing fees charged by accredited laboratories
- Fees for document preparation and consultancy
- Audit expenses if using notified bodies
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with CDSCO-approved testing laboratories and schedule tests well in advance.
Challenge 2: Incomplete Documentation
- Solution: Use detailed checklists and templates for Device Master File and Plant Master File. Our Device Master File guide can help streamline this.
Challenge 3: Audit Non-Compliance
- Solution: Prepare your facility and quality systems according to ISO 13485:2016 standards. Conduct internal audits to preempt issues.
Challenge 4: Query Resolution Delays
- Solution: Designate a dedicated regulatory affairs specialist to respond quickly to CDSCO queries.
Expert Consultation and Support
Navigating the MD9 licensing for Diagnostic Radiology Catheters requires specialized knowledge. With over 25 years of regulatory experience, we provide end-to-end support including:
- Preparation of Test License and MD9 applications
- Compilation of Device and Plant Master Files
- Coordination with notified bodies and CDSCO inspectors
- Strategic planning to meet timelines and reduce costs
We recommend consulting with experts familiar with CDSCO’s evolving guidelines to avoid costly pitfalls.
Getting Started with Your CDSCO License Application
Begin by registering on the CDSCO MD Online Portal and downloading the required forms (MD13 for test license, MD7 for MD9 license). Simultaneously, initiate product testing at an approved laboratory.
Create comprehensive Device and Plant Master Files using our detailed guides, ensuring alignment with CDSCO requirements. Prepare your manufacturing site for inspection by implementing a robust Quality Management System.
Early preparation and proactive communication with regulatory authorities can reduce approval time significantly. For tailored assistance, reach out to our regulatory consulting team experienced in Class C device licensing.
By following these structured steps, manufacturers and importers of Diagnostic Radiology Catheters can successfully obtain CDSCO licenses and access the expanding Indian healthcare market with confidence.
