CDSCO License for Gastrojejunostomy tube
Medical Device Information
Intended Use
A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine.
Comprehensive CDSCO License Guide for Gastrojejunostomy Tube (Class C Medical Device)
Gastrojejunostomy tubes are critical gastroenterology devices designed to provide enteral feeding and gastric decompression for patients unable to feed orally due to physical disabilities or gastrointestinal obstructions. Given their invasive nature and significant patient impact, these tubes are classified as Class C medical devices under the CDSCO regulatory framework, requiring stringent compliance for market authorization in India.
With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we provide a detailed, step-by-step guide tailored for manufacturers and importers of Gastrojejunostomy tubes aiming to enter the Indian market efficiently and compliantly.
CDSCO Regulatory Framework for Gastrojejunostomy Tubes
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Gastrojejunostomy tubes fall under the notified medical device category as per Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, within the gastroenterology segment. These devices require a license issued by the Central Licensing Authority due to their Class C risk classification.
Understanding this regulatory framework is crucial to ensure compliance, avoid delays, and successfully launch your product in India.
Risk Classification and License Requirements
According to the CDSCO classification system, medical devices are categorized into four risk classes: A (low risk), B (low-moderate risk), C (moderate-high risk), and D (high risk). Gastrojejunostomy tubes are Class C devices, indicating moderate to high risk and necessitating a more rigorous licensing process.
For Class C devices, the manufacturing license is granted via Form MD9 by the Central Licensing Authority. Importers similarly require an MD15 import license from CDSCO.
Manufacturing License Process for Class C Devices (MD9 License)
The MD9 license is mandatory for manufacturing Class C medical devices such as Gastrojejunostomy tubes. The process involves several key stages:
Test License Acquisition (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license allowing sample products to undergo mandatory testing in CDSCO-approved laboratories.
Product Testing: Samples must be tested for compliance with applicable Indian and international standards. Testing laboratories approved by CDSCO can be found on the official CDSCO website.
Documentation Preparation: Comprehensive documentation including technical files, quality management systems, and risk management files must be compiled.
Application Submission (Form MD7): The manufacturing license application is submitted online via the CDSCO MD Online Portal.
Audit and Inspection: CDSCO officials conduct an on-site audit to verify compliance with manufacturing practices and documentation.
Query Resolution: Any queries raised by CDSCO during the review or audit phase must be addressed promptly.
Grant of License (Form MD9): Upon satisfactory compliance, the manufacturing license is granted.
Manufacturing License Documents Required for Gastrojejunostomy Tubes
To streamline your application, ensure you have the following documents ready:
- Company constitution and registration certificates
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience documents of technical staff
- Fire and environmental (pollution) clearances
- Device Master File (DMF) detailing device design, specifications, and manufacturing processes. Our Device Master File guide provides expert insights.
- Plant Master File (PMF) outlining manufacturing facility details – refer to our Plant Master File guide
- Essential Principles Checklist demonstrating compliance with Indian regulatory requirements
- Risk Management File specific to Gastrojejunostomy tubes, highlighting hazard analysis and mitigation strategies. More on risk management
- Test reports from CDSCO-approved labs
- Product labels, packaging inserts, and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process for Gastrojejunostomy Tubes (MD15 License)
If you are an importer of Gastrojejunostomy tubes, obtaining an MD15 import license from CDSCO's Central Licensing Authority is mandatory. The process is as follows:
Documentation Compilation: Unlike manufacturing, no test license is needed, but you must submit comprehensive documentation.
Application Submission: File the application on Form MD14 through the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO reviews submitted documents and may raise queries.
License Grant: Once all conditions are met, the import license (Form MD15) is granted.
Import License Documents Required
Prepare the following documents for your import license application:
- Valid manufacturing license from the country of origin
- Free Sale Certificate or Certificate to Foreign Government
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license for distribution
- Company constitution documents
Timeline and Processing Duration
- MD9 Manufacturing License: Approximately 4-5 months, including 1.5-2 months for the test license and product testing.
- MD15 Import License: Typically 5-6 months.
Plan your product launch accordingly to accommodate these regulatory timelines and avoid market entry delays.
Government Fees and Costs
- MD9 License Fees: Rs. 50,000 per application + Rs. 1,000 per product.
- MD15 Import License Fees: For Class C devices, Rs. 3,000 per site + Rs. 1,500 per product.
Budgeting for these fees upfront is crucial to avoid procedural interruptions.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing.
- Solution: Engage early with CDSCO-approved testing laboratories and submit a robust test license application.
Challenge: Incomplete or inconsistent documentation causing audit queries.
- Solution: Utilize expert consultation to prepare comprehensive Device and Plant Master Files and ensure all technical documents adhere to CDSCO guidelines.
Challenge: Difficulty in coordinating audits and addressing CDSCO queries.
- Solution: Maintain clear communication with CDSCO officials and keep documentation readily accessible.
Expert Consultation and Support
Navigating the Class C medical device licensing process can be complex. Our team, with over 25 years of regulatory expertise and a track record of facilitating 500+ successful CDSCO licenses, offers personalized consulting services. We assist with:
- Document preparation including DMF, PMF, and Risk Management Files
- Coordination with testing laboratories and notified bodies
- Application submission and audit facilitation
- Query response and compliance assurance
Consult with us early to mitigate risks and accelerate your market entry.
Getting Started with Your CDSCO License Application for Gastrojejunostomy Tubes
Assess Device Classification: Confirm your device as Class C using the Medical Device Classification resource.
Gather Initial Documentation: Begin compiling your company and device-specific documents.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Engage Testing Labs: Coordinate product testing with accredited labs listed on the CDSCO portal.
Prepare Technical Files: Develop your Device Master File, Plant Master File, and Risk Management File.
Submit Manufacturing License Application: Complete and file Form MD7 for the MD9 license.
Plan for Audit: Schedule and prepare for on-site audits by CDSCO inspectors.
With careful planning and expert guidance, obtaining your CDSCO license for Gastrojejunostomy tubes can be a streamlined process, helping you deliver essential medical solutions to patients across India.
For more detailed assistance, feel free to contact our regulatory experts who specialize in medical device licensing.
By following this comprehensive guide, manufacturers and importers of Gastrojejunostomy tubes can confidently navigate the CDSCO regulatory landscape, minimize risks, and achieve timely approval for their Class C medical devices.
