CDSCO License for Implanted Subcutaneous Intravascular Port & Catheter

Understanding Implanted Subcutaneous Intravascular Port & Catheter and Its Regulatory Importance

Implanted Subcutaneous Intravascular Ports & Catheters are critical medical devices designed for repeated vascular access, facilitating infusion of fluids, medications, and blood sampling. Given their direct interaction with the vascular system, these devices are categorized under Class C risk by the Central Drugs Standard Control Organization (CDSCO) in India. This classification reflects a moderate-to-high risk profile necessitating stringent regulatory oversight to ensure safety, efficacy, and quality.

For manufacturers and importers aiming to enter the Indian market, obtaining the appropriate CDSCO licenses is a mandatory step. Navigating this regulatory pathway can be complex, especially for Class C devices like implanted catheters, but with over 25 years of experience and having supported 500+ companies, we provide clear, actionable guidance to streamline your approval process.

CDSCO Regulatory Framework for Implanted Subcutaneous Intravascular Port & Catheter

The CDSCO classifies medical devices based on risk levels, placing implanted subcutaneous intravascular ports and catheters under Class C devices as per the notification 29/Misc/3/2017-DC (292) dated 06.06.2018. This classification mandates compliance with specific manufacturing and import licensing regulations, primarily governed by:

• MD9 License: For manufacturing Class C devices, issued by the Central Licensing Authority.
• MD15 License: For importing Class C devices, also issued by the Central Licensing Authority.

Both licenses require rigorous documentation, testing, and audits to verify compliance with Indian and international standards.

Risk Classification and License Requirements for Class C Implanted Catheters

Class C devices like implanted subcutaneous intravascular ports and catheters carry moderate to high risk due to their invasive nature and interaction with the vascular system. Therefore, CDSCO requires:

• MD9 Manufacturing License (Form MD7) for domestic production.
• MD15 Import License (Form MD14) for bringing these devices into India.

The MD9 license involves a detailed process including test license acquisition, product testing, and audit by CDSCO inspectors, whereas the MD15 license focuses on thorough document evaluation and compliance verification without the requirement of a test license.

Manufacturing License Process (MD9) for Implanted Subcutaneous Intravascular Port & Catheter

The MD9 manufacturing license process is comprehensive and can take approximately 4 to 5 months from application to grant. The steps include:

1. Obtaining a Test License (Form MD13): This initial phase takes about 1.5 to 2 months and permits manufacturing for testing purposes.
2. Product Testing: Testing must be conducted at CDSCO-approved government laboratories to ensure compliance with quality and safety standards. You can check the list of testing laboratories authorized by CDSCO.
3. Document Preparation: Prepare detailed technical dossiers including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Submission of Application (Form MD7): Apply through the CDSCO MD Online Portal with all required documents.
5. Audit by CDSCO Inspectors: A thorough inspection is conducted at the manufacturing site to verify compliance with Good Manufacturing Practices (GMP) and quality management systems.
6. Resolution of Queries: Address any deficiencies or questions raised by department officials or auditors promptly.
7. Grant of MD9 License: Upon successful completion, the license is issued on Form MD9.

Manufacturing License Documents Required for Implanted Catheter

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing infrastructure and quality controls (Plant Master File Guide)
• Essential Principles Checklist complying with Indian Medical Device Rules
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process (MD15) for Implanted Subcutaneous Intravascular Port & Catheter

For companies importing Class C implanted catheters into India, the MD15 import license procedure typically takes 5 to 6 months. Key steps include:

1. Document Preparation: Assemble documents including the manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and Wholesale License.
2. Application Submission (Form MD14): File your application on the CDSCO MD Online Portal.
3. Departmental Review and Queries: Promptly respond to any queries raised by CDSCO.
4. Grant of MD15 License: Upon satisfactory evaluation, the import license is issued on Form MD15.

Unlike manufacturing licenses, no test license is required for import applications.

Import License Documents Required

Essential documents for MD15 import license applications include:

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certificate
• CE Certificate or Other International Approvals
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Registration Proof
• Product Labels, IFU, and Risk Management File

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License: Rs 50,000 per application plus Rs 1,000 per product.
• MD15 Import License: Fees vary by risk class; for Class C devices, the fees are approximately $3,000 per site and$1,500 per product.

Note: Additional costs for product testing, audits by notified bodies, and consultancy services may apply.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with CDSCO-approved testing laboratories and ensure your samples and dossiers meet their requirements to avoid retesting.

Challenge 2: Incomplete Documentation

• Solution: Utilize comprehensive checklists and templates for Device Master Files and Plant Master Files. Our Device Master File guide and Plant Master File guide are excellent resources.

Challenge 3: Audit Non-Compliance

• Solution: Prepare thoroughly for CDSCO audits by conducting internal mock audits and ensuring your QMS aligns with ISO 13485:2016 standards.

Challenge 4: Query Resolution Delays

• Solution: Establish a dedicated regulatory team to monitor and respond promptly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience and having assisted more than 500 companies, we provide end-to-end regulatory consulting tailored for Class C medical devices such as implanted subcutaneous intravascular ports and catheters. Our services include:

• Licensing strategy and application preparation
• Documentation support including DMF and PMF compilation
• Coordination with CDSCO and notified bodies
• Audit preparation and compliance training
• Post-approval regulatory maintenance

Engage with us early to avoid common pitfalls and accelerate your market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class C using reliable resources like the Medical Device Classification guide.
2. Register on CDSCO MD Online Portal: Set up your account at the CDSCO MD Online Portal to initiate application submission.
3. Prepare Key Documents: Compile your Device Master File, Plant Master File, Risk Management File, and other regulatory documents.
4. Select Testing Laboratory: Coordinate with CDSCO-approved testing labs early to schedule product testing.
5. Apply for Test License (if Manufacturing): Submit Form MD13 to obtain your test license.
6. Plan for Audit: Identify and engage CDSCO inspectors or notified bodies for audits.
7. Submit Final Application: Complete your license application on the portal with all necessary documentation.

Starting with these practical steps and leveraging expert guidance will position your implanted subcutaneous intravascular port & catheter product for successful CDSCO licensing and market launch in India.