CDSCO License for Transenteric drainage tube

Comprehensive Guide to CDSCO Licensing for Transenteric Drainage Tubes (Class C Medical Devices)

Transenteric drainage tubes represent a critical advancement in gastroenterology, providing a minimally invasive method for draining pancreatic pseudocysts or biliary obstructions via endoscopic implantation. Classified as Class C medical devices under CDSCO regulations, these sterile, non-bioabsorbable tubes demand rigorous compliance with India’s regulatory framework to ensure patient safety and device efficacy.

With over 25 years of experience and having guided 500+ companies through successful CDSCO licensing, we provide a detailed roadmap tailored for manufacturers and importers of transenteric drainage tubes aiming to enter the Indian market.

CDSCO Regulatory Framework for Transenteric Drainage Tubes

The Central Drugs Standard Control Organization (CDSCO) governs approval and licensing of medical devices in India, ensuring devices meet safety, quality, and performance standards. For transenteric drainage tubes, the applicable notification is 29/Misc./03/2020-DC (182) dated 27.09.2021, categorizing it under gastroenterology and Class C risk.

Being Class C, these devices carry moderate to high risk, necessitating central licensing authority oversight and strict adherence to quality management systems like ISO 13485:2016.

For comprehensive details on device classifications, you can refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Class C Devices

Class C devices require obtaining the MD9 Manufacturing License, issued by the Central Licensing Authority (CLA), and the MD15 Import License if the device is to be imported.

• MD9 License (Form MD7): Mandatory for manufacturing Class C devices.
• MD15 License (Form MD14): Mandatory for importing Class C devices.

The process involves product testing, quality system audits, and thorough documentation review to comply with regulatory expectations.

Manufacturing License Process for Transenteric Drainage Tubes (MD9 License)

The MD9 license process spans approximately 4 to 5 months and includes several key stages:

1. Test License Application (Form MD13): Before the MD9 license, manufacturers must obtain a test license to conduct product testing. This typically takes 1.5 to 2 months.

2. Product Testing: Testing must be performed at CDSCO-approved laboratories to verify compliance with applicable standards. You can access the list of approved testing laboratories here.

3. Document Preparation: Comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS records must be prepared.

4. Application Submission: Submit application Form MD7 through the CDSCO MD Online Portal for the MD9 license.

5. Audit and Inspection: CDSCO inspectors conduct audits of the manufacturing site and QMS compliance.

6. Resolution of Queries: Address any queries raised by CDSCO or auditors promptly.

7. License Grant: Upon satisfactory review, the MD9 license is granted providing legal authorization to manufacture the device in India.

For a step-by-step walkthrough, see our detailed MD9 License Guide.

Manufacturing License Documents Required for MD9

Ensuring all required documents are accurate and complete is crucial to avoid processing delays:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (See our DMF guide)
• Plant Master File (PMF) describing manufacturing facility and processes (Read our PMF guide)
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File demonstrating hazard analysis and mitigation (Explore risk management)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Import License Process for Transenteric Drainage Tubes (MD15 License)

For importers, obtaining an MD15 license is mandatory before marketing transenteric drainage tubes in India. The process generally takes 5 to 6 months:

1. Document Preparation: Compile required documents including manufacturing license from the origin country, Free Sale Certificate, CE Certificate, and QMS certifications.

2. Application Submission: Submit Form MD14 for MD15 license through the CDSCO MD Online Portal.

3. Queries and Clarifications: Address any questions or deficiencies raised by CDSCO.

4. License Grant: Upon successful review, the MD15 import license is issued.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Delays typically arise from incomplete documentation or unresolved audit findings. Prompt response to CDSCO queries can significantly improve timelines.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: Rs. 50,000
  • Per Product Fee: Rs. 1,000

• MD15 Import License:

  • Class C & D: $3,000 per site +$1,500 per product

Budgeting for testing, consulting, and possible re-submissions is essential for smooth approval.

Common Challenges and Solutions

• Incomplete Documentation: Meticulously cross-check document checklists to avoid rejections.
• Testing Delays: Choose CDSCO-approved labs with proven turnaround times.
• Audit Preparedness: Conduct internal audits and mock inspections before CDSCO audits.
• Regulatory Updates: Stay updated on notifications and policy changes from CDSCO.

Our consulting experience shows that proactive planning and expert guidance can mitigate these common pain points effectively.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like transenteric drainage tubes is complex. Our team has successfully assisted over 500 companies with tailored strategies:

• Preparing robust DMFs and PMFs
• Coordinating with testing laboratories
• Ensuring QMS compliance
• Managing audit readiness and query responses

Leverage our expertise to streamline your licensing journey and reduce time-to-market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C to align with MD9/MD15 licensing.
2. Initiate Test License: Submit Form MD13 via the CDSCO MD Online Portal to begin testing.
3. Engage Approved Testing Labs: Schedule product testing early to accommodate lab timelines.
4. Prepare Comprehensive Documentation: Utilize our guides on Device Master Files and Plant Master Files.
5. Submit MD9 License Application: After successful testing and document readiness, apply using Form MD7.
6. Plan for Audit: Train your team and ready your facility for CDSCO inspection.

Begin your CDSCO licensing journey today with a clear roadmap and expert support to ensure successful market entry for your transenteric drainage tube. Reach out to our regulatory consultants for personalized assistance tailored to your device and business goals.