CDSCO License for Paediatric- temperature nasogastric/orogastric tube

Comprehensive CDSCO Licensing Guide for Paediatric Temperature Nasogastric/Orogastric Tubes (Class B)

Introduction: Understanding Paediatric Temperature Nasogastric/Orogastric Tubes and Regulatory Importance

Paediatric temperature nasogastric/orogastric tubes are critical medical devices designed specifically for neonatal and pediatric care. These sterile, thin, flexible hollow cylinders enable enteral feeding or oral medication delivery through nasal or oral routes, while also incorporating an integrated thermistor sensor near the distal tip to continuously monitor oesophageal temperature. Typically single-use and available in various diameters, these devices play an essential role in intensive care units and neonatal wards.

Given their direct contact with vulnerable patient populations and their integral monitoring function, regulatory compliance is paramount. Obtaining the appropriate CDSCO license ensures that your product meets India’s stringent safety, quality, and performance standards, enabling smooth market entry.

CDSCO Regulatory Framework for Paediatric Temperature Nasogastric/Orogastric Tubes

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules (MDR) 2017. This device falls under the pediatric and neonatology category and is classified as a Class B medical device, indicating a moderate risk profile.

Under MDR, all manufacturers and importers must obtain valid licenses to legally manufacture or import these devices. The regulatory framework mandates compliance with documentation, testing, quality management systems, and audits to safeguard patient health.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered moderate risk. For paediatric temperature nasogastric/orogastric tubes, this classification requires a manufacturing license under Form MD5, granted by the State Licensing Authority. If importing, an import license under Form MD15, granted by the Central Licensing Authority, is mandatory.

The Medical Device Classification guide offers deeper insight into the classification rationale.

Manufacturing License Process (MD5) for Paediatric Temperature Nasogastric/Orogastric Tubes

For manufacturers aiming to produce this Class B device domestically, the MD5 license is essential. The entire process generally spans 3 to 4 months and includes the following steps:

1. Obtain Test License (Form MD13): Apply for a test license, valid for 6 months, allowing product testing in government-approved labs. This stage takes roughly 1.5 to 2 months.

2. Product Testing: Submit samples to CDSCO-recognized labs for performance, sterility, biocompatibility, and safety tests. Refer to the Testing Laboratories list for approved facilities.

3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. License Application (Form MD3): Submit your manufacturing license application online via the CDSCO MD Online Portal.

5. Audit by Notified Body: Arrange for an audit by a Notified Body accredited to verify compliance with MDR and QMS standards.

6. Query Resolution: Promptly address any queries raised by CDSCO or the notified body.

7. License Grant (Form MD5): Upon satisfactory completion, the State Licensing Authority issues the manufacturing license.

Practical Tip:

Manufacturers should start with the test license early and maintain continuous communication with testing labs to avoid delays. Establishing a robust Quality Management System (QMS) aligned with ISO 13485:2016 significantly smooths the audit process.

Manufacturing License Documents Required

The document dossier for MD5 license includes:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff with Qualifications
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications and design
• Plant Master File (PMF) describing manufacturing facilities and equipment
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating thorough hazard analysis and mitigation strategies
• Test Reports from government-approved labs
• Labeling and Instructions for Use (IFU) samples
• Quality Management System documentation, including SOPs and CAPA procedures

For detailed guidance on compiling the DMF and PMF, review our Device Master File guide and Plant Master File guide.

Import License Process (MD15) for Paediatric Temperature Nasogastric/Orogastric Tubes

Importers seeking to bring this Class B device into India must obtain the MD15 license from the CDSCO Central Licensing Authority. The process typically takes 5 to 6 months and proceeds as follows:

1. Document Compilation: Prepare necessary documents including the overseas manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.

2. License Application (Form MD14): Submit the application online via the CDSCO MD Online Portal.

3. Query Resolution: Address any clarifications sought by CDSCO in a timely manner.

4. License Issuance (Form MD15): Upon approval, the import license is granted.

Unlike manufacturing licenses, test licenses are generally not required for import applications.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License for Importer
• Company Constitution and Address Proof

Timeline and Processing Duration

Government Fees and Costs

Manufacturing License (MD5) for Class B devices:

• Application Fee: Rs. 5,000
• Per Product Fee: Rs. 500

Import License (MD15) for Class B devices:

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

Additional costs include testing fees charged by laboratories, audit fees by notified bodies, and internal costs for document preparation and QMS implementation.

Common Challenges and Solutions

Challenge 1: Delays in Testing and Audit Scheduling

• Solution: Pre-book testing slots and notified body audits, maintain proactive follow-ups.

Challenge 2: Documentation Gaps Leading to Query Backlogs

• Solution: Utilize comprehensive checklists and expert consulting to ensure complete documentation.

Challenge 3: Understanding Regulatory Updates

• Solution: Regularly monitor CDSCO notifications and guidance documents; subscribe to trusted regulatory newsletters.

Challenge 4: QMS Implementation for MDR Compliance

• Solution: Adopt ISO 13485:2016 certified processes and conduct internal audits before CDSCO inspections.

Expert Consultation and Support

With over 25 years of experience and support to 500+ companies, we specialize in guiding manufacturers and importers through the complex CDSCO licensing landscape. From detailed documentation assistance, audit readiness, to regulatory strategy, our expert team ensures your paediatric temperature nasogastric/orogastric tube complies fully and expedites market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm with the CDSCO guidelines that your product is Class B.
2. Prepare test samples: Coordinate with government-approved labs listed on the CDSCO Testing Laboratories portal.
3. Establish QMS: Implement ISO 13485:2016 standards and document your processes.
4. Compile essential files: Develop your Device Master File and Plant Master File using our comprehensive guides.
5. Apply for test license (for manufacturing): Submit Form MD13 through the CDSCO MD Online Portal.
6. Engage with notified bodies: Schedule audits early by referring to the official Notified Bodies list.
7. Submit manufacturing or import license application: Use Form MD3 for MD5 manufacturing license or Form MD14 for MD15 import license.

For personalized assistance tailored to your paediatric device, reach out to our consultancy team. Our proven approach minimizes regulatory delays and maximizes compliance, accelerating your path to Indian market authorization.