CDSCO License for Gastrostomy button

Comprehensive Guide to CDSCO Licensing for Gastroscopy Button (Class C Medical Device)

As a specialized medical device used in gastroenterology, the gastrostomy button is a critical device designed to facilitate long-term enteral feeding via a percutaneous route. Classified as a Class C device under the CDSCO framework, it demands rigorous regulatory compliance to ensure safety and efficacy in the Indian market. With over 25 years of experience and having supported 500+ manufacturers and importers, we bring you an expert roadmap for obtaining relevant CDSCO licenses for this device.

Understanding the CDSCO Regulatory Framework for Gastrostomy Button

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, enforcing compliance for manufacturing, import, and marketing. The gastrostomy button, notified under 29/Misc./03/2020-DC (182) on 27.09.2021, falls under Class C due to its medium-to-high risk profile.

This classification means that manufacturers require a MD9 Manufacturing License, granted by the Central Licensing Authority, while importers must obtain an MD15 Import License. Both processes are designed to uphold stringent quality, safety, and performance standards.

Risk Classification and License Requirements for Gastrostomy Button

• Risk Class: Class C (medium-to-high risk)
• Regulatory Category: Gastroenterology
• Applicable Licenses:
  • Manufacturing: MD9 License (Application Form MD7)
  • Import: MD15 License (Application Form MD14)

For a detailed understanding of device classification, please refer to our Medical Device Classification guide.

Manufacturing License Process (MD9) for Gastrostomy Button

The MD9 license process is thorough and involves multiple stages:

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

2. Product Testing: Samples must be tested at CDSCO-approved government laboratories. You can locate these via the Testing Laboratories list.

3. Documentation Preparation: Assemble comprehensive documentation including Device Master File, Plant Master File, risk management, and essential principles checklist.

4. Application Submission (Form MD7): Apply via the CDSCO MD Online Portal for the MD9 license.

5. Inspection & Audit: CDSCO inspectors will audit manufacturing facilities and documents.

6. Queries Resolution: Address any observations or queries raised by the department.

7. License Grant: Upon satisfactory review and audit, the MD9 license is granted on Form MD9.

For a detailed walkthrough, see our MD9 License Guide.

Manufacturing License Documents Required for Class C Device

• Company Constitution (MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) documenting design and manufacturing process (Device Master File guide)
• Plant Master File detailing manufacturing facilities (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File tailored for the gastrostomy button (Risk Management guide)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Gastrostomy Button

Importers of gastrostomy buttons must secure the MD15 license from the Central Licensing Authority. The process is as follows:

1. Documentation Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Queries Resolution: Respond promptly to any clarifications sought by CDSCO officials.

4. License Issuance: After satisfactory review, the MD15 import license is issued.

For detailed guidance, explore our Import License Guide.

Import License Documents Required for Gastrostomy Button

• Valid manufacturing license (MD9) from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Quality Management Certification
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company Constitution and address proof

Timeline and Processing Duration

• MD9 Manufacturing License: 4 to 5 months total

  • Test license (MD13): 1.5 to 2 months
  • Testing and documentation: ~1 month
  • CDSCO audit and review: 1.5 to 2 months

• MD15 Import License: Approximately 5 to 6 months

Timelines may vary based on the completeness of submissions and promptness in addressing queries.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Product Fee: ₹1,000 per product

• MD15 Import License:

  • Class C devices: ₹3,000 per site
  • Product Fee: ₹1,500 per product

These fees are payable via the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in product testing

• Solution: Engage with CDSCO-approved labs early and pre-schedule testing to avoid backlogs.

Challenge 2: Incomplete or inconsistent documentation

• Solution: Use checklists and templates for compiling Device and Plant Master Files, ensuring alignment with CDSCO requirements.

Challenge 3: Audit non-compliance

• Solution: Conduct internal mock audits and training sessions for staff before CDSCO inspections.

Challenge 4: Query resolution delays

• Solution: Maintain a dedicated regulatory team to respond promptly with supporting evidence.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for Class C devices like the gastrostomy button requires precision and expertise. Our experienced consultants provide:

• Gap analysis of existing documentation
• Preparation and review of DMF, PMF, and risk management files
• Coordination with notified bodies and testing labs
• Representation during audits and inspections
• End-to-end application management

Getting Started with Your CDSCO License Application

To initiate your licensing journey for the gastrostomy button, follow these practical steps:

1. Assess Device Classification: Confirm Class C status per CDSCO notifications.

2. Develop QMS: Implement ISO 13485:2016 compliant quality systems.

3. Prepare Device & Plant Master Files: Utilize expert templates to document design and manufacturing processes.

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

5. Coordinate Product Testing: Engage CDSCO-approved labs early.

6. Compile Full Documentation: Ensure all required documents are complete and accurate.

7. Submit MD9 Application: Once testing is successful, apply for the manufacturing license.

8. Prepare for Audit: Conduct internal audits and address any gaps.

9. Address Queries Promptly: Facilitate smooth CDSCO review.

10. Plan for Import License (MD15): Once manufacturing license is granted, start preparing import license documentation if applicable.

By taking these focused actions, manufacturers and importers can efficiently navigate CDSCO licensing for gastrostomy buttons, ensuring timely market entry and regulatory compliance.

For further assistance, feel free to reach out to our expert team with 25+ years of proven success in CDSCO licensing.