CDSCO License for Gastro-oesophageal pH/impedance catheter, non-sterile

Introduction to Gastro-oesophageal pH/Impedance Catheters and Regulatory Importance

The Gastro-oesophageal pH/impedance catheter is a specialized medical device designed to assess gastro-oesophageal reflux and related gastrointestinal disorders such as GERD and gastric ulcers. This non-sterile, flexible tube equipped with electronic sensors is inserted nasally to provide critical diagnostic data. Given its clinical significance and patient safety considerations, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers wishing to market this device in India.

Navigating the CDSCO licensing process can be complex. With over 25 years of experience and having supported 500+ companies, we provide you with a detailed, actionable roadmap tailored for this Class B device to ensure a smooth and timely approval.

CDSCO Regulatory Framework for Gastro-oesophageal pH/Impedance Catheters

As per the CDSCO Medical Device Classification, the Gastro-oesophageal pH/impedance catheter falls under Class B due to its moderate risk profile. This classification means the device is subject to regulatory oversight primarily at the state level under the MD5 license regime.

The regulatory framework requires compliance with:

• Device safety and performance standards
• Quality Management System (QMS) adherence (ISO 13485:2016 recommended)
• Submission of detailed technical documentation, including risk management and clinical evaluation

This device is notified under Notification No. 29/Misc./03/2020-DC (182) dated 27.09.2021, which mandates licensing before manufacture or import in India.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• Applicable License: MD5 Manufacturing License, issued by the State Licensing Authority
• Application Form: MD3 for manufacturing

Since this is a Class B device, the manufacturer must obtain the MD5 license following successful completion of a test license and product testing phases. Importers must secure the MD15 license from CDSCO Central Licensing Authority.

Manufacturing License Process (MD5)

The MD5 licensing process for a Class B device like the Gastro-oesophageal pH/impedance catheter involves the following key steps:

1. Test License (Form MD13): Apply for a test license to manufacture the device prototype. This is mandatory before manufacturing full-scale batches.
2. Product Testing: Get the device tested at government-approved laboratories for compliance with essential principles and performance standards. Testing laboratories list is available on the CDSCO MD portal.
3. Document Preparation: Compile technical documentation, including Device Master File, Plant Master File, risk management files, and clinical data.
4. License Application (Form MD3): Submit the manufacturing license application online through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct a facility audit to verify compliance. Refer to the list of notified bodies for audit requirements.
6. Queries and Clarifications: Respond to any queries from CDSCO or the notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory review and audit, the MD5 license is issued.

Practical Tip:

Start documentation early, especially risk management and device master files, to avoid delays during the audit phase.

Manufacturing License Documents Required

For the Gastro-oesophageal pH/impedance catheter (Class B), the CDSCO mandates the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details of Technical Staff and their Qualifications
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (DMF Guide)
• Plant Master File (PMF) with details of manufacturing facility (PMF Guide)
• Essential Principles Checklist covering safety and performance
• Risk Management File aligned with ISO 14971 (Risk Management Guide)
• Test Reports from government-approved labs confirming compliance
• Labels and Instructions for Use (IFU) with complete device information
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15)

If you are an importer of this device, the MD15 license is mandatory and is issued by the CDSCO Central Licensing Authority. The process involves:

1. Document Preparation: Gather necessary certificates such as manufacturing license, Free Sale Certificate, CE mark, ISO 13485:2016 certification.
2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
3. Review and Queries: CDSCO evaluates the documents and may raise queries.
4. Grant of License (Form MD15): After satisfactory review, the import license is granted.

Unlike manufacturing, a test license is not required for imports.

Import License Documents Required

Essential documents for MD15 license application include:

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate from the country of manufacture
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

For import license (MD15), expect 5 to 6 months due to central processing.

Government Fees and Costs

• MD5 Manufacturing License:

  • Rs. 5000 per application
  • Rs. 500 per product (each variant of catheter)

• Test License (MD13): Usually included in the process; check with CDSCO for fees.

• Import License (MD15): Fees vary by device class; for Class B devices, typically:

  • USD 2000 per site
  • USD 1000 per product

Note: Additional costs include notified body audit fees, testing lab charges, and consultancy fees if engaged.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-book slots at government-approved labs and ensure samples meet testing criteria.

Challenge 2: Incomplete Documentation

• Solution: Use our comprehensive Device Master File guide and Plant Master File guide to prepare accurate documents.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits and pre-audit training for staff. Engage notified bodies early.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated personnel to monitor CDSCO communications and respond promptly.

Expert Consultation and Support

With over two decades of expertise and a track record of 500+ successful CDSCO licenses, we provide end-to-end support—from documentation to audit preparation and submission—tailored specifically for Gastroenterology devices like the pH/impedance catheter.

Our services include:

• Gap analysis and regulatory strategy
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Timely application submission and follow-up

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

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm Class B status and understand applicable regulations.
2. Initiate Test License Application (MD13): Prepare necessary documents and submit via the CDSCO MD Online Portal.
3. Prepare Technical Documentation: Start compiling your Device Master File, Plant Master File, risk management files, and QMS documentation.
4. Schedule Product Testing: Contact government-approved labs and arrange for sample testing.
5. Plan for Audit: Identify notified bodies early and prepare your manufacturing facility accordingly.
6. Submit Manufacturing License Application (Form MD3): After successful testing and documentation readiness.
7. Monitor Application Progress: Regularly check status and respond to queries without delay.

By following these steps with expert guidance, manufacturers can secure their MD5 manufacturing license for Gastro-oesophageal pH/impedance catheters efficiently, ensuring compliance and timely access to the Indian market.

For more detailed assistance, explore our tailored MD5 License Guide and connect with our regulatory consultants.