CDSCO License for Closed-ended wearable urine collection bag, sterile

Introduction to Closed-Ended Wearable Urine Collection Bag and Regulatory Importance

The closed-ended wearable urine collection bag is a sterile, flexible plastic pouch intended to be connected to a urinary catheter and strapped to a patient's leg for discreet urine collection. Designed without an opening for drainage, it ensures hygiene and patient comfort, making it essential in urology care. Given its medical nature and direct contact with bodily fluids, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory to ensure safety, efficacy, and quality.

With over 25 years of experience supporting more than 500 medical device manufacturers and importers, we understand the nuances involved in securing the appropriate CDSCO license for this Class A device. Proper licensing not only facilitates smooth market entry but also builds trust among healthcare providers and end-users.

CDSCO Regulatory Framework for Closed-Ended Wearable Urine Collection Bags

According to the CDSCO classification notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, this device falls under the urology category and is classified as a Class A medical device, which represents low risk. CDSCO regulates manufacturing and import of medical devices through defined licensing pathways, ensuring adherence to quality standards and safety requirements.

Risk Classification and License Requirements

Our device is classified as Class A, the lowest risk category, which requires obtaining the MD5 Manufacturing License if you intend to produce the device in India. If importing, an MD15 Import License is mandatory.

• Class A Device: MD5 License (Manufacturing) through State Licensing Authority
• Import License: MD15 License granted by Central Licensing Authority

This classification impacts the complexity, timeline, and cost of the regulatory process.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license process is managed by the State Licensing Authority and typically spans 3 to 4 months. The process involves several key steps:

1. Test License (Form MD13): Initiate with obtaining a test license, which generally takes 1.5 to 2 months.
2. Product Testing: Samples must be tested at CDSCO-approved government laboratories to ensure compliance with applicable standards. View the list of Testing Laboratories.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and more.
4. Application Submission: Apply via the CDSCO MD Online Portal using Form MD3.
5. Notified Body Audit: A notified body will conduct an audit of your manufacturing facility. You can check the list of notified bodies authorized for this process.
6. Query Resolution: Address any queries from the department or notified body promptly.
7. License Grant: Upon satisfactory review and audit, the MD5 license will be issued.

Manufacturing License Documents Required

For a closed-ended wearable urine collection bag (Class A), you must prepare and submit comprehensive documentation, including but not limited to:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed product information, materials, and manufacturing processes. For guidance, refer to our Device Master File guide.
• Plant Master File (PMF): Manufacturing facility details; see our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian medical device standards
• Risk Management File documenting hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Closed-Ended Urine Bags

Manufacturers or distributors intending to import this Class A device must obtain an MD15 import license from the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

1. Document Preparation: Collect all necessary certificates such as Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and Wholesale License.
2. Application Submission: Submit the application on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to any clarifications or additional requirements raised by CDSCO.
4. License Issuance: Upon successful review, the MD15 import license is granted.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution
• Details of products to be imported

Timeline and Processing Duration

Manufacturers should plan for possible delays due to audit scheduling and query resolution.

Government Fees and Costs

For the MD5 license related to this Class A device:

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

For import under MD15 license:

• Site Fee: Approx. $1,000 per site
• Product Fee: Approx. $50 per product

These fees are subject to change, so always verify the latest fees on the CDSCO portal.

Common Challenges and Solutions

1. Delayed Test License Approval: Start early and ensure all test license documents are complete and compliant.
2. Incomplete Documentation: Use detailed checklists for Device Master File and Plant Master File preparation.
3. Audit Non-compliance: Pre-audit your manufacturing facility with a notified body to identify gaps.
4. Query Resolution Delays: Assign dedicated personnel to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time manufacturers or importers of Class A devices like closed-ended urine collection bags. Our 25+ years of regulatory consulting experience have helped over 500 companies successfully obtain their licenses with minimal delays. We assist with:

• Comprehensive documentation preparation
• Pre-audit readiness assessments
• Submission management on the CDSCO MD Online Portal
• Liaison with notified bodies and CDSCO officials
• Post-license compliance support

Getting Started with Your CDSCO License Application

To begin your CDSCO licensing journey for the closed-ended wearable urine collection bag, follow these practical steps:

1. Classify Your Device: Confirm the risk class and applicable license type using the Medical Device Classification resources.
2. Prepare Test License Application: Gather required documents and apply for Form MD13 via the CDSCO MD Online Portal.
3. Engage with Testing Laboratories Early: Coordinate product testing at CDSCO-approved labs.
4. Compile Device and Plant Master Files: Leverage our guides to assemble thorough and compliant master files.
5. Schedule Notified Body Audit: Identify and book audits with notified bodies listed here.
6. Submit Manufacturing License Application (Form MD3): Once test license and testing are complete.
7. Maintain Clear Communication: Respond swiftly to CDSCO queries to avoid delays.

By adhering to these steps and leveraging our expert support, your path to securing the MD5 manufacturing license for your closed-ended wearable urine collection bag will be efficient and compliant, enabling you to enter the Indian market confidently.