CDSCO License for Gastro- Enterostomy Tube

Comprehensive Guide to CDSCO Licensing for Gastro-Enterostomy Tubes (Class B Catheters)

Navigating the regulatory landscape for medical devices in India can be challenging, especially for specialized products like the Gastro-Enterostomy Tube. This device, classified under Class B risk and categorized as a catheter, requires compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework to legally manufacture or import in India. With over 25 years of experience and having successfully guided more than 500 companies, we provide you with a detailed, practical roadmap to obtain your CDSCO license efficiently.

Understanding the Gastro-Enterostomy Tube and Its Regulatory Importance

The Gastro-Enterostomy Tube is a vital medical device used for enteral feeding, placed through the abdominal wall into the stomach and then advanced through the duodenum into the jejunum. Given its invasive nature and critical intended use, the device is classified as Class B under CDSCO regulations, indicating a moderate risk level.

Ensuring regulatory compliance is not only a legal mandate but also a critical step to guarantee patient safety and market access. The notification number 29/Misc/3/2017-DC (292), dated 06.06.2018, specifically covers this device category, and thus manufacturers and importers must follow the prescribed licensing routes.

CDSCO Regulatory Framework for Gastro-Enterostomy Tubes

The CDSCO governs medical device regulation under the Drugs and Cosmetics Act, 1940. For Class B devices like Gastro-Enterostomy Tubes, the manufacturing license falls under the MD5 license category, granted by the State Licensing Authority. The regulatory pathway includes:

• Obtaining a Test License (Form MD13)
• Product testing in government-approved labs
• Submission of a comprehensive application (Form MD3) for the MD5 license
• Audit by a notified body
• Resolution of any departmental queries
• Granting of the final manufacturing license (Form MD5)

For importers, the process differs and requires an MD15 Import License obtained from the Central Licensing Authority.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. According to CDSCO classification, the Gastro-Enterostomy Tube falls under this category because of its invasive nature but limited duration of use inside the body.

• Manufacturing License: MD5 License (State Authority)
• Test License: Required before MD5 application (Form MD13)
• Import License: Separate MD15 license from Central Authority

The entire manufacturing licensing process typically spans 3 to 4 months, including testing and audit.

Manufacturing License Process for Gastro-Enterostomy Tubes (MD5)

1. Test License Application (Form MD13):

   • Submit your test license application via the CDSCO MD Online Portal.
   • Approval usually takes 1.5 to 2 months.

2. Product Testing:

   • Conduct tests at CDSCO-recognized laboratories to validate safety and performance.
   • Refer to the Testing Laboratories list for suitable labs.

3. Prepare Application for Manufacturing License (Form MD3):

   • Compile technical and legal documents including Device Master File, Plant Master File, Quality Management System (QMS), and risk management files.
   • Include test reports, labels, and Instructions for Use (IFU).

4. Audit by Notified Body:

   • Arrange audit through a list of notified bodies.
   • The audit evaluates compliance with GMP and QMS.

5. Respond to Queries:

   • Address any observations raised by CDSCO or the notified body promptly.

6. Grant of License (Form MD5):

   • Upon satisfactory review and audit, the State Authority issues the MD5 license.

Manufacturing License Documents Required for Gastro-Enterostomy Tubes

To streamline your application, ensure you have the following documents ready:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details with Qualifications and Experience
• Fire NOC and Pollution Control Board Clearance
• Device Master File (DMF) – detailed design and manufacturing information (Guide to DMF)
• Plant Master File (PMF) – manufacturing site and process details (PMF Guide)
• Essential Principles Checklist confirming compliance with Indian and international standards
• Risk Management File in compliance with ISO 14971 (Risk Management Insights)
• Test Reports from government-recognized labs
• Labels and IFU Samples
• Quality Management System (QMS) Documents (preferably ISO 13485 certified)

Import License Process for Gastro-Enterostomy Tubes (MD15)

For importers aiming to introduce Gastro-Enterostomy Tubes into the Indian market, an MD15 license is mandatory.

1. Document Preparation:

   • Assemble manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and other technical dossiers.

2. Application Submission:

   • File the application on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution:

   • Address any queries raised by CDSCO promptly.

4. Grant of MD15 License:

   • Typical processing time is 5 to 6 months.

Import License Documents Required

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License of the importing company
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 License (Manufacturing Class B):

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 License (Import for Class B):

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Please note these fees are subject to change; always verify on the official CDSCO MD Online Portal.

Common Challenges and Practical Solutions

• Incomplete Documentation: In our experience, nearly 40% of delays stem from missing or poorly prepared documents. Using detailed checklists and consulting expert guides like our MD5 License Guide can prevent this.

• Delay in Product Testing: Government labs often have backlogs. To mitigate, plan testing early and consider multiple accredited labs from the Testing Laboratories list.

• Audit Non-Compliance: Pre-audit mock inspections can help identify gaps in GMP and QMS, reducing the risk of adverse findings.

• Query Resolution Delays: Assign a dedicated regulatory liaison to respond swiftly to departmental queries.

Expert Consultation and Support

With over two decades of hands-on regulatory consulting, we offer tailored support for every licensing stage—from document preparation, audit readiness, to submission follow-up. Our expertise spans over 500 successful CDSCO license approvals, including complex Class B devices like Gastro-Enterostomy Tubes.

We recommend engaging expert consultants early to navigate regulatory nuances, avoid costly mistakes, and speed up market entry.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm your device falls under Class B using tools like the Medical Device Classification guide.

2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO online portal.

3. Schedule Product Testing: Contact government-approved labs and book slots early.

4. Organize Required Documentation: Assemble your DMF, PMF, and QMS files, using our expert guides.

5. Plan for Audit: Engage a notified body from the official list and conduct internal audits.

6. Submit Manufacturing License Application (MD5): Once tests and audits are complete, apply through the CDSCO portal.

7. Stay Responsive: Monitor application status regularly and address any CDSCO queries promptly.

By following these actionable steps and leveraging expert guidance, manufacturers and importers of Gastro-Enterostomy Tubes can confidently achieve compliance and access the Indian medical device market.

For personalized assistance, reach out to our regulatory consultants who specialize in CDSCO licensing for Class B medical devices.