CDSCO License for Closed-ended adhesive infant/paediatric urine collection bag

Introduction to Closed-ended Adhesive Infant/Pediatric Urine Collection Bag and Regulatory Importance

The closed-ended adhesive infant/paediatric urine collection bag is a crucial single-use medical device designed specifically for pediatrics and neonatology. This sterile, flexible plastic pouch with an adhesive flange is intended for non-invasive urine collection from infants and pediatric patients for biochemical, cytological, or bacteriological analysis. Its closed-ended design prevents urine drainage, ensuring sample integrity. Given the sensitive patient population and clinical application, regulatory oversight is stringent to guarantee safety, sterility, and efficacy.

For manufacturers and importers aiming to enter the Indian market with this device, obtaining the appropriate CDSCO license is mandatory. Compliance with the Central Drugs Standard Control Organization (CDSCO) regulations ensures market authorization and builds trust with healthcare providers and end-users.

CDSCO Regulatory Framework for Closed-ended Adhesive Infant Urine Collection Bags

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. Your device falls under the pediatric and neonatology category and is classified as Class B (low to moderate risk). This classification dictates the licensing process, responsible authority, and documentation requirements.

The CDSCO framework mandates manufacturers of Class A and B devices to obtain a manufacturing license via the MD5 route, while importers require an MD15 import license. This ensures that only compliant devices enter the Indian healthcare system.

Risk Classification and License Requirements for Class B Devices

Class B devices, including your closed-ended adhesive urine collection bag, are considered low to moderate risk. According to CDSCO classification guidelines, such devices require:

• Manufacturing License: MD5 license granted by the State Licensing Authority.
• Import License: MD15 license granted by the Central Licensing Authority.

The MD5 license process involves several steps, including obtaining a test license (MD13), product testing, audit by a notified body, and final license issuance.

For detailed classification criteria, visit our Medical Device Classification resource.

Manufacturing License Process (MD5) for Closed-ended Adhesive Infant Urine Collection Bags

The MD5 manufacturing license is mandatory for domestic manufacturers. The process unfolds as follows:

1. Apply for a Test License (Form MD13): This initial step takes approximately 1.5 to 2 months and allows you to manufacture the device for testing purposes.
2. Product Testing: You must get the device tested at government-approved laboratories to verify compliance with essential principles, sterility, and biocompatibility. Refer to the Testing Laboratories list for authorized labs.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, QMS documents, Risk Management File, labels, and Instructions for Use (IFU).
4. Submit Application for Manufacturing License (Form MD3): Upload your application on the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit conducted by a notified body listed here will verify compliance with quality and manufacturing standards.
6. Resolve Queries: Address any clarifications raised by the department or notified body promptly.
7. Grant of MD5 License: On successful completion, the license is issued on Form MD5.

The entire MD5 process typically takes 3 to 4 months from start to finish.

Manufacturing License Documents Required for Class B Device

To streamline your application, prepare the following key documents:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Covers design, specifications, manufacturing processes, and testing. See our Device Master File Guide
• Plant Master File (PMF): Details of manufacturing facilities and quality controls. Learn more at our Plant Master File Guide
• Essential Principles Checklist
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management)
• Test Reports from Government Approved Laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485 certifications

Organizing these documents accurately accelerates the review and approval process.

Import License Process (MD15) for Closed-ended Adhesive Infant Urine Collection Bags

For importers, the MD15 license is compulsory before marketing the device in India. The steps include:

1. Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.
3. Departmental Review: The CDSCO evaluates documents and may raise queries.
4. Grant of MD15 License: Upon satisfactory review, the import license is issued.

Note that the import license process usually takes 5 to 6 months. Unlike manufacturing, no test license is required.

Import License Documents Required for Class B Device

Prepare the following for your import license application:

• Valid Manufacturing License from Exporting Country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Ensure all certificates are current and translated into English if necessary.

Timeline and Processing Duration

Planning your market entry with these timelines in mind helps prevent costly delays.

Government Fees and Costs

For Class B closed-ended adhesive urine collection bags, the fees are as follows:

• MD5 Manufacturing License:

  • Rs 5000 per application
  • Rs 500 per product

• MD15 Import License:

  • $2000 per site
  • $1000 per product

Budgeting these fees upfront avoids surprises during application.

Common Challenges and Solutions

Challenge: Delays in test reports from government labs.

Solution: Engage with approved labs early; consider their capacity and turnaround times.

Challenge: Incomplete documentation causing multiple queries.

Solution: Use checklists and expert consultation to ensure all documents meet CDSCO standards.

Challenge: Audit non-compliance due to QMS gaps.

Solution: Implement ISO 13485 aligned QMS and conduct internal audits before the notified body visit.

Challenge: Understanding risk management requirements.

Solution: Follow structured risk management processes as outlined in our Risk Management guide.

Expert Consultation and Support

With over 25 years of experience and assisting more than 500 companies, we specialize in CDSCO licensing for pediatric medical devices like the closed-ended adhesive infant urine collection bag. Our tailored support includes:

• Comprehensive gap analysis and documentation preparation
• Coordination with notified bodies and testing labs
• Step-by-step application management on the CDSCO MD Online Portal
• Post-licensing compliance and audit readiness

Our hands-on experience ensures smoother approvals and faster market access.

Getting Started with Your CDSCO License Application

1. Classify Your Device Accurately: Confirm your device is Class B per CDSCO guidelines.
2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin manufacturing for testing.
3. Select Government Approved Testing Lab: Choose from the official Testing Laboratories list.
4. Prepare Complete Technical Documentation: Assemble Device Master File, Plant Master File, QMS, Risk Management File, and other essential documents.
5. Schedule Notified Body Audit: Coordinate with a notified body from the Notified Bodies List for your audit.
6. Submit Manufacturing License Application (Form MD3): Upload your application once test reports and audit are complete.
7. Monitor Application Progress: Respond promptly to any queries from CDSCO or the notified body.

Taking these actionable steps early optimizes your chances of timely license grant, enabling you to bring your innovative pediatric urine collection bag to the Indian healthcare market efficiently and compliantly.