CDSCO License for General-purpose ureteral catheter

Introduction to General-Purpose Ureteral Catheter and Regulatory Importance

The general-purpose ureteral catheter is a vital urology medical device designed as a flexible tube for introduction into the ureters via a cystoscope or nephroscope. Given its direct contact with internal urinary pathways, regulatory compliance is critical to ensure patient safety and market access in India. As specialists with over 25 years of experience and having supported 500+ manufacturers and importers, we understand the nuances involved in securing your CDSCO license for this Class B device.

CDSCO Regulatory Framework for Urology Devices Like Ureteral Catheters

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. Since the notification dated 23.8.2021 (File No. 29/Misc./03/2020-DC (145)), general-purpose ureteral catheters fall under Class B risk classification. This means regulatory controls are moderate, requiring a manufacturing license (MD5) granted by the State Licensing Authority.

Risk Classification and License Requirements for the Ureteral Catheter

Class B devices, including general-purpose ureteral catheters, require an MD5 manufacturing license. The process involves obtaining a test license (MD13) first, followed by product testing, documentation, and audit compliance. Importers will require an MD15 license issued by the CDSCO Central Licensing Authority.

For more details on classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for General-Purpose Ureteral Catheters

The MD5 license process typically spans 3 to 4 months and involves the following steps:

1. Test License (MD13) Application: Submit your test license application on the CDSCO MD Online Portal to commence product testing.
2. Product Testing: Conduct tests at CDSCO-approved laboratories to verify compliance with Indian standards. A list of Testing Laboratories is available.
3. Document Preparation: Compile required documentation including Device Master File and Plant Master File.
4. License Application Submission (Form MD3): Apply for the manufacturing license with all supporting documents.
5. Audit by Notified Body: A CDSCO-recognized notified body conducts an on-site audit to verify compliance. Check the list of notified bodies to select your auditor.
6. Query Resolution: Address any observations or queries raised during audit or by the licensing authority.
7. Grant of License (Form MD5): Upon satisfactory review, the license is granted.

For a detailed walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required for General-Purpose Ureteral Catheters

Your application must be supported with comprehensive documentation including:

• Company constitution and registration proof
• Proof of ownership or lease of manufacturing premises
• Qualification details and experience certificates of technical staff
• Fire and pollution clearance certificates
• Device Master File detailing design, specifications, and manufacturing process. Our Device Master File guide can assist.
• Plant Master File describing facility layout and quality controls. Learn how to prepare one in our Plant Master File guide.
• Essential Principles Checklist confirming adherence to regulatory requirements
• Risk Management File documenting hazard analysis and mitigation strategies
• Test reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) compliant with Indian regulations
• Quality Management System (QMS) documents, ideally ISO 13485 certified

Import License Process (MD15) for Ureteral Catheters

If you intend to import the general-purpose ureteral catheter, you must secure an MD15 import license from the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license
• Submission of application via the CDSCO MD Online Portal
• Resolution of any queries raised by the licensing authority
• Final grant of the MD15 license

For a stepwise guide, refer to our Import License Guide.

Timeline and Processing Duration

Planning your application timeline with these benchmarks helps avoid costly delays.

Government Fees and Costs for MD5 License

For Class B devices like the ureteral catheter, fees are as follows:

• Application fee: Rs 5,000 per application
• Product fee: Rs 500 per product

These fees are payable via the CDSCO portal during application submission. Additional costs include testing fees at approved labs and audit fees charged by notified bodies.

Common Challenges and Solutions

Challenge: Delay in Product Testing

Solution: Engage early with CDSCO-approved laboratories to book testing slots and ensure samples meet testing criteria.

Challenge: Incomplete Documentation

Solution: Use comprehensive checklists for Device and Plant Master Files and consult our guides to avoid missing critical documents.

Challenge: Audit Non-Compliance

Solution: Conduct internal pre-audit assessments to ensure QMS, premises, and technical staff qualifications meet CDSCO standards.

Challenge: Query Resolution Delays

Solution: Respond promptly and comprehensively to queries with supporting evidence to expedite license grant.

Expert Consultation and Support

Navigating CDSCO licensing for Class B urology devices requires expertise. We have successfully guided over 500 manufacturers and importers through the licensing maze. Our services include:

• Gap analysis of your current documentation
• Preparation of Device and Plant Master Files
• Liaising with notified bodies and testing labs
• Application drafting and submission via CDSCO MD Online Portal
• Training your technical and regulatory teams for compliance

Reach out to us early to leverage our proven track record and avoid common pitfalls.

Getting Started with Your CDSCO License Application for General-Purpose Ureteral Catheters

1. Assess Device Classification: Confirm that your ureteral catheter is Class B under CDSCO regulations.
2. Initiate Test License (MD13) Application: Prepare basic documents and submit via the CDSCO portal.
3. Schedule Product Testing: Coordinate with CDSCO-approved labs to test your catheter samples.
4. Compile Documentation: Begin preparing your Device Master File, Plant Master File, risk management files, and QMS documents.
5. Select a Notified Body: Choose an appropriate notified body for your audit from the official list.
6. Plan for Audit: Prepare your facility and staff for the audit to ensure compliance.
7. Submit MD5 License Application: Once testing and documentation are ready, submit your application (Form MD3) online.
8. Engage with Regulatory Queries: Respond promptly to any audits or CDSCO queries.

Our team is ready to assist you through every step. Contact us today to streamline your CDSCO licensing journey and bring your general-purpose ureteral catheter to the Indian market efficiently and compliantly.