CDSCO License for Stomach Evaculator(Gastric Lavage) Tube

Comprehensive Guide to CDSCO Licensing for Stomach Evaculator (Gastric Lavage) Tube – Risk Class B Medical Device

Introduction: Understanding the Stomach Evaculator Tube and Regulatory Importance

The Stomach Evaculator, commonly known as a Gastric Lavage Tube, is a critical medical device used for the passage of a tube via the mouth or nose into the stomach. This facilitates the sequential administration and removal of small volumes of liquid—an essential procedure in emergency medicine, toxicology, and critical care. Categorized under catheters and designated as a Class B medical device by the Central Drugs Standard Control Organization (CDSCO), its manufacturing and import are strictly regulated to ensure patient safety and device efficacy.

Given the vital role this device plays in clinical settings, adherence to CDSCO’s regulatory framework is non-negotiable. A robust licensing process ensures that manufacturers and importers comply with quality standards, risk management practices, and documentation requirements before entering the Indian market.

CDSCO Regulatory Framework for Stomach Evaculator (Gastric Lavage) Tube

The regulatory oversight for this device falls under CDSCO’s medical device rules as notified in 2018 (Notification 29/Misc/3/2017-DC (292)). As a Class B device, it requires a manufacturing license (MD5) from the State Licensing Authority. Importers must seek an import license (MD15) granted by the Central Licensing Authority.

Our extensive experience with over 500 companies has shown that early engagement with the regulatory framework and thorough preparation are key to a smooth approval process.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low-moderate risk and fall under Schedule I of the Medical Device Rules, 2017. This classification mandates:

• Manufacturing License (MD5 License): Issued by the State Licensing Authority using Application Form MD3.
• Test License (MD13): Required prior to full manufacturing license to allow initial testing and compliance checks.

For your Stomach Evaculator Tube, the MD5 license process is applicable, which involves product testing, documentation, audit by a notified body, and final license grant.

Manufacturing License Process (MD5 License) for Stomach Evaculator Tube

The MD5 manufacturing license process typically spans 3-4 months and progresses through these stages:

1. Test License Application (Form MD13): Allows manufacturing for testing purposes. Processing time is approximately 1.5-2 months.
2. Product Testing: Conduct tests at CDSCO-approved laboratories to verify device safety and performance. Refer to the list of testing laboratories for accredited facilities.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body listed here to verify compliance.
6. Resolution of Queries: Promptly address any observations or queries from the licensing authority or notified body.
7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

Manufacturing License Documents Required for Stomach Evaculator Tube

Key documents needed include:

• Company Constitution/Registration Certificate
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing infrastructure and processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File demonstrating risk assessment and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Stomach Evaculator Tube

If you intend to import the Stomach Evaculator Tube rather than manufacture it locally, the MD15 import license is required. The process, managed by the Central Licensing Authority, includes:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Application submission via Form MD14 on the CDSCO MD Online Portal.
• Departmental review and resolution of queries.
• License issuance within 5-6 months.

Note that no test license is required for import licenses, but stringent documentation and quality certifications are mandatory.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

For the Stomach Evaculator Tube (Class B), expect the following approximate timelines:

Proactive document preparation and early engagement with notified bodies can significantly reduce delays.

Government Fees and Costs

The fee structure for Class B device licensing is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product.
• MD13 Test License: Fees included as part of the manufacturing license process.
• MD15 Import License: For Class B, fees are approximately $2,000 per site +$1,000 per product.

Additional costs may include testing fees at government-approved laboratories and audit charges by the notified body.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation

• Solution: Utilize detailed checklists and expert guidance to ensure all files, such as DMF, PMF, risk management, and test reports, are complete and compliant.

Challenge 2: Delays in Product Testing

• Solution: Schedule tests early with accredited labs and maintain frequent communication to expedite results.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits prior to notified body inspections and address gaps proactively.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience advising 500+ medical device companies, we offer tailored regulatory consulting to navigate the complexities of CDSCO licensing seamlessly. From document preparation, audit readiness, to liaison with CDSCO officials, our end-to-end support minimizes risk and accelerates market entry.

Getting Started with Your CDSCO License Application for Stomach Evaculator Tube

1. Assess Your Device Classification: Confirm Class B status using CDSCO’s medical device classification resource.
2. Prepare Essential Documents: Compile your DMF, PMF, risk management files, and QMS documentation.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to begin the testing phase.
4. Select a Government-Approved Testing Laboratory: Early identification of a lab from the official list expedites compliance.
5. Engage a Notified Body for Audit: Choose from the notified bodies list and schedule your audit.
6. Submit Manufacturing License Application (Form MD3): Post successful testing and audit.
7. Respond Promptly to Queries: Maintain clear communication with CDSCO and notified bodies.

By following these practical steps and leveraging expert support, manufacturers and importers can confidently secure CDSCO licensing for the Stomach Evaculator Tube and successfully access the Indian healthcare market.

For detailed guidance on the MD5 licensing process specific to Class B devices, visit our MD5 License Guide.

Contact us today to begin your CDSCO licensing journey with trusted expertise and ensure compliant, timely market access for your Stomach Evaculator Tube.