CDSCO License for Long-term use enterostomy  feeding tube

Comprehensive Guide to CDSCO Licensing for Long-Term Use Enterostomy Feeding Tubes (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies, we understand the complexities involved in securing CDSCO licenses for specialized medical devices like the long-term use enterostomy feeding tube. This device, classified as a Class C medical device under the CDSCO framework, is vital in providing enteral nutrition via a surgically placed hollow tube in the stomach, duodenum, or jejunum for extended periods.

Navigating the regulatory landscape efficiently is crucial for manufacturers and importers aiming to market this device in India. In this guide, we provide actionable insights, timelines, cost structures, and document requirements specific to this device type and risk class.

CDSCO Regulatory Framework for Long-Term Use Enterostomy Feeding Tubes

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacturing of medical devices in India. The long-term enterostomy feeding tube, falling under Risk Class C due to its invasive nature and prolonged usage, requires strict compliance with CDSCO regulations to ensure patient safety and device efficacy.

India’s regulatory framework mandates that manufacturers obtain a Manufacturing License (MD9) from the Central Licensing Authority, while importers need an Import License (MD15). The notified file number for this device category is 29/Misc/03/2020-DC (199), with notification dated 13.9.2021.

Risk Classification and License Requirements for Class C Devices

Class C devices are considered moderate to high risk, warranting centralized regulatory control. The long-term enterostomy feeding tube, due to its critical role in nutrition and invasive placement, falls squarely in this category.

• Manufacturing License: MD9 License (Form MD7) granted by the Central Licensing Authority.
• Import License: MD15 License (Form MD14) also granted by the Central Licensing Authority.

Understanding the license type is fundamental to preparing your application accurately and avoiding costly delays.

Manufacturing License Process (MD9) for Class C Medical Devices

The MD9 licensing process involves multiple steps:

1. Test License (Form MD13): Manufacturers must first obtain a test license to initiate product testing. This typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to confirm compliance with Indian standards.
3. Documentation Preparation: Compile all required technical and quality documents.
4. Application Submission: File the MD9 application (Form MD7) via the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors will conduct a thorough audit of manufacturing facilities.
6. Query Resolution: Respond promptly to any departmental or audit queries.
7. License Grant: Upon satisfactory review, the MD9 license is granted.

Manufacturing License Documents Required

For the MD9 license of the enterostomy feeding tube, the following documents are essential:

• Company Constitution: Proof of legal entity (e.g., MOA, AOA).
• Ownership Proof of Premises: Lease or ownership documents.
• Technical Staff Credentials: Qualification and experience certificates of key personnel.
• Fire and Pollution NOCs: Clearances from local authorities.
• Device Master File (DMF): Comprehensive technical dossier detailing design, materials, and safety data. Our Device Master File guide provides detailed preparation steps.
• Plant Master File (PMF): Documentation of manufacturing processes and quality systems. Refer to our Plant Master File guide for assistance.
• Essential Principles Checklist: Compliance checklist covering all applicable standards.
• Risk Management File: Documentation of identified risks and mitigation strategies as per ISO 14971. Learn more about risk management.
• Test Reports: Results from CDSCO-approved testing labs. A list of Testing Laboratories is available for reference.
• Labels and Instructions for Use (IFU): Drafts complying with Indian labeling norms.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.

Import License Process (MD15) for Long-Term Enterostomy Feeding Tubes

Importers of Class C devices must secure an MD15 license by following these steps:

1. Document Preparation: Gather all mandatory documents including manufacturing license and certifications.
2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
3. Department Review: The CDSCO reviews the application and may raise queries.
4. Grant of License: After satisfactory review, the MD15 import license is issued.

Import License Documents Required

Key documents for MD15 import license include:

• Valid Manufacturing License (MD9 or equivalent) from country of origin.
• Free Sale Certificate: Issued by the regulatory authority of the exporting country.
• ISO 13485:2016 Certificate: Demonstrating quality management compliance.
• CE Certificate: Indicative of compliance with European standards.
• Device Master File and Plant Master File: For Indian regulatory review.
• Wholesale Drug License: For distribution purposes.
• Company Constitution Documents

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4 to 5 months total.

  • Test license issuance: 1.5 – 2 months
  • Product testing: 1 month (may vary)
  • Document preparation & application submission: 2 weeks
  • CDSCO Audit and clearance: 1 to 1.5 months
  • Query resolution: 2 – 3 weeks

• MD15 Import License: Approximately 5 to 6 months.

Being proactive in document preparation and prompt in query resolution can significantly reduce these timelines.

Government Fees and Costs

• MD9 License:
  • Application fee: ₹50,000
  • Per product fee: ₹1,000
• MD15 License: Fees vary by risk class:
  • Class C devices: ₹3,000 per site and ₹1,500 per product

Additional costs include testing laboratory fees (variable, depending on tests), notified body audit charges, and consultant fees if applicable.

Common Challenges and Solutions

• Delayed Testing Results: Plan testing schedules in advance and choose CDSCO-approved labs with quick turnaround. Refer to the Testing Laboratories list.
• Document Gaps: Utilize checklists and templates from expert guides to avoid incomplete submissions.
• Audit Non-Conformities: Conduct internal pre-audits and engage with notified bodies listed on the Notified Bodies List for readiness.
• Query Delays: Assign a dedicated regulatory liaison to ensure timely responses.

Expert Consultation and Support

Our extensive experience means we can guide you through each regulatory step, from preparing the Device Master File to scheduling audits and responding to CDSCO queries. With over 500 successful CDSCO license approvals, we offer tailored solutions that minimize delays and optimize compliance.

Getting Started with Your CDSCO License Application

1. Assess your Device Classification: Confirm Class C status using the Medical Device Classification guide.
2. Initiate Test License Application (MD13): Prepare and submit this form on the CDSCO MD Online Portal.
3. Plan Testing and Document Preparation: Simultaneously engage with notified testing labs and begin assembling your technical dossiers.
4. Engage a Notified Body Early: Schedule your audit to align with testing completion.
5. Submit your MD9 Application (Form MD7): Once all prerequisites are met, apply via the CDSCO portal.

Starting early and leveraging expert guidance will streamline your path to market entry for your long-term enterostomy feeding tube. For detailed assistance tailored to your product and organizational needs, contact our regulatory consultancy today.

By following this roadmap, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring compliance, accelerating approvals, and ultimately delivering safe, effective enterostomy feeding devices to Indian patients.