CDSCO License for Subcutaneous Intraspinal Port & Catheter

Comprehensive Guide to CDSCO Licensing for Subcutaneous Intraspinal Port & Catheter (Risk Class C)

Subcutaneous Intraspinal Ports & Catheters are critical medical devices used for epidural and intrathecal infusions, encompassing both short-term externalized catheters and long-term tunnelled catheters placed in subcutaneous tissue. Classified as Class C devices under CDSCO regulations, these catheters require stringent regulatory compliance due to their invasive nature and potential impact on patient safety.

With over 25 years of experience advising 500+ medical device companies, we understand the complexities involved in obtaining the necessary CDSCO licenses for such devices. This comprehensive guide provides practical insights, timelines, costs, and documentation requirements to help manufacturers and importers successfully navigate the regulatory landscape in India.

CDSCO Regulatory Framework for Subcutaneous Intraspinal Port & Catheter

The Central Drugs Standard Control Organization (CDSCO) regulates import, manufacture, and sale of medical devices in India. As per the Ministry of Health and Family Welfare Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, Subcutaneous Intraspinal Ports & Catheters fall under the catheter category and are classified as Class C medical devices due to their medium-to-high risk profile.

The regulatory pathway for these devices involves compliance with the Medical Device Rules, 2017 (amended), and obtaining the MD9 manufacturing license (for local production) or MD15 import license (for importers), both managed centrally by CDSCO.

Risk Classification and License Requirements for Class C Devices

Class C devices, including Subcutaneous Intraspinal Ports & Catheters, require a manufacturing license under Form MD7 (MD9 License) granted by the CDSCO Central Licensing Authority. This classification mandates rigorous documentation, testing, and audits to ensure device safety and efficacy.

Key points for Class C licensing:

• License Type: MD9 Manufacturing License
• Application Form: MD7
• Authority: Central Licensing Authority - CDSCO
• Processing Time: Approximately 4-5 months
• Fees: Rs 50,000 per application plus Rs 1,000 per product

For importers, the MD15 license is required with a longer timeline of about 5-6 months.

To verify device classification and regulatory updates, manufacturers can refer to our detailed Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD9) for Subcutaneous Intraspinal Port & Catheter

1. Test License Application (Form MD13):

   • Initially, you must apply for a Test License to conduct product testing.
   • Processing timeline: 1.5 to 2 months.
   • Testing must be performed at CDSCO-approved laboratories.

2. Product Testing:

   • Testing is mandatory to demonstrate conformity with Indian standards and essential principles.
   • Refer to the list of CDSCO-approved Testing Laboratories.

3. Document Preparation:

   • After receiving test reports, prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. License Application Submission (Form MD7):

   • Submit the complete application through the CDSCO MD Online Portal with all required documents.

5. Audit by CDSCO Inspectors:

   • CDSCO will schedule an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and QMS.

6. Query Resolution:

   • Respond promptly to any queries or deficiencies raised by CDSCO inspectors or the technical committee.

7. Grant of MD9 License:

   • Upon satisfactory review and audit, the MD9 license will be issued, enabling legal manufacture of the Subcutaneous Intraspinal Port & Catheter in India.

For an in-depth overview, our MD9 License Guide provides practical tips and checklists.

Essential Documents Required for MD9 License Application

To streamline application submission, ensure all documents are complete and up to date:

• Company Constitution/ Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing process documents. See our Device Master File Guide.
• Plant Master File (PMF): Facility layout, equipment, and personnel details. Learn more in our Plant Master File Guide.
• Essential Principles Checklist: Compliance matrix with Indian and international standards.
• Risk Management File: Documentation of risk analysis and mitigation strategies. Refer to our Risk Management implementation guide.
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: SOPs, CAPA, Training records, etc.

Ensuring accuracy and completeness of these documents reduces the risk of delays or rejections.

Import License Process (MD15) for Subcutaneous Intraspinal Port & Catheter

Importers of Class C devices must obtain an MD15 license via CDSCO’s Central Licensing Authority. The process includes:

• Document Preparation: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Application Submission: File Form MD14 through the CDSCO MD Online Portal.
• Query Resolution: Address any technical or administrative queries.
• License Grant: Typically processed within 5-6 months.

Fees vary by risk class; for Class C devices, expect approximately $3,000 per site and$1,500 per product.

Our Import License Guide offers detailed procedural advice.

Timeline and Processing Duration

Planning ahead and preparing robust documentation can shorten review times.

Government Fees and Costs

• MD9 License Application Fee: Rs 50,000 per application
• Per Product Fee: Rs 1,000 per product
• Test License Fee (MD13): Rs 5,000
• Testing Costs: Vary based on lab and number of tests
• Audit and Compliance Costs: May include fees for Notified Body audits or consultancy

Budgeting for these fees upfront facilitates smooth financial planning during licensing.

Common Challenges and Practical Solutions

• Delayed Testing and Lab Reports: Ensure early engagement with CDSCO-approved labs. Check the Testing Laboratories list for availability and turnaround times.

• Incomplete Documentation: Use detailed checklists and expert consultation to avoid omissions, particularly in DMF, PMF, and Risk Management files.

• Audit Non-Conformities: Prepare your manufacturing site with mock audits and rigorous internal quality assurance.

• Query Management: Respond comprehensively and within stipulated timelines to avoid application hold-ups.

• Regulatory Updates: Stay current with CDSCO notifications and amendments to avoid surprises.

Our experience shows that proactive planning and expert support significantly mitigate these risks.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like Subcutaneous Intraspinal Port & Catheter requires regulatory expertise and process knowledge. Our team offers:

• Customized regulatory strategy development
• Document preparation and review
• Liaison with CDSCO and notified bodies
• Training and audit support
• Post-license compliance monitoring

Partnering with seasoned consultants reduces risks and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Classify Your Device Accurately: Confirm classification as Class C based on its intended use and CDSCO notifications.

2. Engage with a CDSCO-Approved Testing Laboratory: Schedule testing early to align with licensing timelines.

3. Prepare Core Documentation: Develop or update your Device Master File, Plant Master File, and risk management documentation.

4. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.

5. Plan for Audit: Ensure your manufacturing site complies with GMP and QMS requirements.

6. Submit Manufacturing License Application (MD9): Use Form MD7 on the CDSCO portal once test results are in.

7. Respond to Queries Promptly: Maintain communication with CDSCO for smooth processing.

Following these steps with professional guidance increases your chances of timely approval and successful market entry.

For further assistance and turnkey solutions, contact our expert regulatory consultancy team, leveraging our 25+ years of experience and proven track record with over 500 successful CDSCO license approvals.