CDSCO License for Closed-ended intestinal ostomy bag, one-piece

Introduction to Closed-ended Intestinal Ostomy Bag and Regulatory Importance

Closed-ended intestinal ostomy bags are specialized medical devices used to collect fecal matter from a colostomy site. Designed as a non-sterile plastic pouch with adhesive backing, this one-piece device is critical for patients requiring fecal diversion following gastrointestinal surgery. Given its direct contact with the patient’s skin and bodily waste, regulatory compliance in India is essential to ensure safety, quality, and efficacy.

At our consultancy, with over 25 years of experience and having guided 500+ manufacturers, we emphasize that securing the correct CDSCO license is a pivotal step for market entry and sustained compliance. For this device, classified as Class A under the CDSCO risk classification system, the MD5 manufacturing license is mandatory.

CDSCO Regulatory Framework for Closed-ended Intestinal Ostomy Bags

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules, 2017. As per the notification number 29/Misc./03/2020-DC (182) dated 27.09.2021, the closed-ended intestinal ostomy bag falls under the Gastroenterology category and is classified as a low-risk Class A device.

This classification mandates a state-level licensing process for manufacturing under the MD5 license, governed by the State Licensing Authority through the CDCSO MD Online Portal.

Risk Classification and License Requirements for Class A Devices

Class A devices are considered low risk and include non-invasive devices that pose minimal potential harm. For closed-ended intestinal ostomy bags, the classification as Class A means:

• License Type: Manufacturing License MD5 (Form MD3 application)
• Regulatory Authority: State Licensing Authority
• Test License: Mandatory initial test license (Form MD13)
• Audit: Conducted by a notified body
• Timeline: Approximately 3-4 months for the entire process

This pathway ensures that manufacturers have appropriate facilities, quality management systems, and product compliance without the more extensive scrutiny required for higher-risk classes.

Manufacturing License Process (MD5) for Closed-ended Intestinal Ostomy Bags

The MD5 license acquisition process is multi-step and includes:

1. Obtaining Test License (Form MD13): This allows manufacturing for testing purposes only and takes 1.5-2 months.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify safety and performance. You can refer to the list of CDSCO-approved testing laboratories for selection.
3. Documentation Preparation: Comprehensive documentation including Device Master File, Plant Master File, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The audit assesses compliance with quality and manufacturing standards. Refer to the list of notified bodies for authorized auditors.
6. Resolution of Queries: Address any observations from the audit or CDSCO.
7. Grant of License (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

Manufacturing License Documents Required for MD5

For a Class A device like the closed-ended intestinal ostomy bag, prepare the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications 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) describing the manufacturing facility (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 recommended)

Import License Process (MD15) for Closed-ended Intestinal Ostomy Bags

If you are an importer rather than a manufacturer, the MD15 import license is mandatory. The process involves:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Application submission via the CDSCO MD Online Portal.
• Review and queries resolution by CDSCO.
• License grant within approximately 5-6 months.

Note that import licensing fees vary by device risk class, with Class A devices attracting lower fees.

Import License Documents Required for MD15

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or other international certifications if applicable
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

For imports, expect 5-6 months from application to license grant.

Government Fees and Costs

For manufacturing the closed-ended intestinal ostomy bag (Class A):

• Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product

Additional costs to consider:

• Testing fees at approved labs
• Audit fees by notified bodies
• Professional consultancy fees (if applicable)

Investing in thorough documentation and quality systems upfront can save costs associated with delays and rejections.

Common Challenges and Solutions

Challenge: Delays in obtaining test reports due to backlog at testing labs.

Solution: Initiate sample testing early and select labs with shorter lead times from the CDSCO testing labs list.

Challenge: Incomplete or poorly prepared Device Master Files leading to audit non-conformities.

Solution: Utilize expert guidance and templates as detailed in our Device Master File Guide.

Challenge: Non-compliance during notified body audits.

Solution: Conduct internal pre-audit gap assessments and ensure QMS aligns with ISO 13485 standards.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time manufacturers or importers. Our 25+ years of consulting experience has empowered over 500 companies to successfully secure licenses for Class A devices like the closed-ended intestinal ostomy bag. We assist with:

• Complete documentation preparation
• Liaison with notified bodies and CDSCO officials
• Pre-audit readiness and corrective action planning
• Training for technical and regulatory teams

Our expert support ensures faster approvals and mitigates risks of non-compliance.

Getting Started with Your CDSCO License Application

To initiate your MD5 manufacturing license for the closed-ended intestinal ostomy bag, follow these practical steps:

1. Register on the CDSCO MD Online Portal: Create your company profile and familiarize yourself with the submission process.
2. Apply for the Test License (Form MD13): Prepare necessary documents and submit early to allow sample production and testing.
3. Select CDSCO-approved testing laboratories: Coordinate sample submission to avoid delays.
4. Compile and organize your Device Master File and Plant Master File: Incorporate risk management and essential principle checklists.
5. Schedule a notified body audit: Contact from the list of notified bodies and plan your audit timeline.
6. Submit the manufacturing license application (Form MD3): Ensure all documents are complete to avoid queries.
7. Prepare for audit and promptly respond to any queries: Engage your regulatory consultant for assistance.

Taking these steps methodically will position your company for a smooth licensing journey, enabling timely market entry and compliance assurance.

For detailed guidance and personalized support, connect with our regulatory experts who specialize in CDSCO medical device licensing.

For more information on the CDSCO MD Online Portal and to access application forms, visit the official website. Explore our specialized guides on the MD5 License Process and Device Master File preparation to streamline your application.