CDSCO License for Enteral feeding/decompression tube clearing stem

Comprehensive Guide to CDSCO Licensing for Enteral Feeding/Decompression Tube Clearing Stem (Class A Medical Device)

Enteral feeding/decompression tube clearing stems are specialized medical devices designed to mechanically clear clogs in nasogastric, nasoenteral, gastrostomy, and jejunostomy tubes. Classified as Class A devices under CDSCO regulations, these non-sterile, sheath-covered stems play a critical role in maintaining luminal patency for feeding and decompression within gastroenterology.

With over 25 years of experience assisting 500+ companies in navigating the CDSCO licensing landscape, we provide you with a detailed, practical roadmap for obtaining your manufacturing or import license for this device. Our goal is to simplify the regulatory journey, ensuring compliance with India's stringent medical device laws while accelerating your market entry.

CDSCO Regulatory Framework for Enteral Feeding/Decompression Tube Clearing Stems

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Enteral feeding/decompression tube clearing stems fall under the gastroenterology category and are notified as Class A devices per the notification number 29/Misc./03/2020-DC (182) dated 27.09.2021.

As a Class A device, regulatory oversight is primarily managed by the State Licensing Authority with specific procedural steps governed by CDSCO’s MD Online Portal. Compliance with essential principles, quality management systems, and risk management is mandatory to ensure patient safety and device efficacy.

Risk Classification and License Requirements

Class A devices represent low-risk medical devices. For this category, a Manufacturing License (MD5) is required if you intend to manufacture within India, and an Import License (MD15) is necessary if you plan to import the device.

• MD5 License (Manufacturing): Issued by State Licensing Authority
• MD15 License (Import): Issued by Central Licensing Authority

Given the device is Class A, the MD5 license process is more streamlined compared to higher risk classes but still entails thorough documentation, testing, and audits.

Manufacturing License Process (MD5) for Enteral Feeding/Decompression Tube Clearing Stem

The MD5 license process for Class A devices involves several key steps:

1. Apply for a Test License (MD13): Before full manufacturing license, a Test License is mandatory. This allows you to produce limited batches for testing.

2. Product Testing: Submit samples to CDSCO-recognized government-approved testing laboratories. You can check the list of approved testing laboratories for suitable options.

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

4. Apply for MD5 License (Form MD3): Submit your manufacturing license application along with all documents through the CDSCO MD Online Portal.

5. Audit by Notified Body: A mandatory audit by a notified body ensures compliance with manufacturing practices. Refer to the Notified Bodies List to select an auditor.

6. Address Queries: Respond promptly to any departmental or auditor queries.

7. Grant of License: Upon satisfactory review and audit, the license will be granted on Form MD5.

Manufacturing License Documents Required

For your Enteral feeding/decompression tube clearing stem, the following documentation is essential:

• Company Constitution (Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire Department No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File detailing design, manufacturing process, and specifications (Our Device Master File guide)
• Plant Master File describing manufacturing site and quality systems (Plant Master File Guide)
• Essential Principles Checklist (demonstrating compliance with safety and performance requirements)
• Risk Management File highlighting risk assessments and mitigation strategies (Risk Management Insights)
• Test Reports from CDSCO approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Enteral Feeding/Decompression Tube Clearing Stem

If you plan to import this device, the MD15 import license process is handled by the Central Licensing Authority and typically takes 5-6 months. The steps include:

1. Document Preparation: Gather all required documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Submit Application (Form MD14): File your import license application via the CDSCO MD Online Portal.

3. Query Resolution: Address any clarifications raised by CDSCO.

4. Grant of Import License (Form MD15): Upon approval, the import license will be issued.

Import License Documents Required

• Manufacturing License issued by the competent authority in the country of origin
• Free Sale Certificate indicating the device is marketed freely
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

Planning your submissions with these timelines in mind helps avoid costly delays.

Government Fees and Costs

• MD5 License:

  • Rs 5,000 per application
  • Rs 500 per product

• MD15 Import License (Class A devices):

  • $1000 per site
  • $50 per product

Additional costs include testing fees at government-approved labs and notified body audit charges, which vary by auditor.

Common Challenges and Solutions

Challenge: Delayed test report issuance from approved labs.

• Solution: Engage with laboratories early, understand their turnaround times, and submit samples promptly.

Challenge: Incomplete documentation leading to query cycles.

• Solution: Use detailed checklists and consult experts to ensure dossier completeness before submission.

Challenge: Audit non-conformities.

• Solution: Conduct internal audits and corrective actions prior to notified body audits.

Challenge: Confusion regarding applicable forms and fees.

• Solution: Refer to official guidelines and consider professional regulatory consultation.

Expert Consultation and Support

Navigating CDSCO licensing demands precision and updated knowledge of regulatory changes. Our 25+ years of expertise has helped over 500 companies achieve timely approvals.

We offer:

• End-to-end application preparation
• Gap analysis of quality systems and documentation
• Coordination with notified bodies and testing labs
• Personalized timelines and cost estimations

Our insights minimize risk of rejection and accelerate your entry into the Indian market.

Getting Started with Your CDSCO License Application

To initiate your licensing journey for the Enteral feeding/decompression tube clearing stem:

1. Register your company and create a login on the CDSCO MD Online Portal.
2. Identify the appropriate State Licensing Authority for MD5 license submission.
3. Secure a Test License (MD13) to commence initial production batches.
4. Schedule product testing with a CDSCO-approved laboratory.
5. Compile comprehensive documentation, leveraging our Device Master File and Plant Master File guides.
6. Reach out to a notified body early to book your audit.
7. Submit your MD5 application with all documents and fees.

By following this strategic approach, you align with regulatory expectations and position your product for successful approval. Contact us to leverage our proven expertise and ensure a smooth licensing process for your enteral feeding/decompression tube clearing stem in India.