CDSCO License for Urinary stone retrieval basket

Comprehensive Guide to CDSCO Licensing for Urinary Stone Retrieval Basket (Class B Medical Device)

Urinary stone retrieval baskets are specialized medical devices designed to facilitate the removal of renal calculi during endoscopic procedures. Classified under Class B (low-moderate risk) in the Indian medical device regulatory framework, these devices play a critical role in nephrology and renal care. Given their direct interaction with the urinary tract and potential patient safety implications, obtaining the appropriate license from the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing this device in India.

With over 25 years of experience assisting more than 500 medical device companies, we provide an all-encompassing overview of the CDSCO licensing process tailored specifically for urinary stone retrieval baskets. Our aim is to simplify the regulatory journey by sharing timelines, fees, document requirements, and insider tips.

CDSCO Regulatory Framework for Urinary Stone Retrieval Basket

The regulatory oversight for urinary stone retrieval baskets falls under the Medical Device Rules, 2017, notified by the Ministry of Health and Family Welfare. These rules categorize medical devices into four risk classes (A, B, C, and D). According to Notification 29/Misc./03/2020-DC (143) dated 13.09.2021, urinary stone retrieval baskets are classified as Class B devices, which require licensing through the State Licensing Authority.

The entire licensing process is managed via the CDSCO MD Online Portal, ensuring transparent application submission, status tracking, and communication.

Risk Classification and License Requirements for Class B Devices

As a Class B device, the urinary stone retrieval basket demands adherence to moderate regulatory controls to ensure safety and efficacy. The relevant license for manufacturing is the MD5 license, issued by the State Licensing Authority. Importers also need to be aware that import licenses fall under MD15, managed by the Central Licensing Authority.

For Class B devices, the MD5 license process involves multiple critical steps, including obtaining a test license (MD13), conducting product testing in government-approved laboratories, completing documentation, and undergoing audits by notified bodies.

Manufacturing License Process (MD5) for Urinary Stone Retrieval Basket

The MD5 license application for Class B devices follows a structured timeline and process:

1. Test License Application (Form MD13): Before full-scale manufacturing, companies must apply for a test license, which takes approximately 1.5 to 2 months to be granted. This license allows initial production for testing purposes.

2. Product Testing: The device must be tested at government-approved labs listed on the Testing Laboratories portal. Testing typically covers biocompatibility, mechanical performance, and safety parameters specific to urinary stone retrieval devices.

3. Document Preparation: Parallel to testing, comprehensive documents such as Device Master File (DMF), Plant Master File (PMF), and Quality Management System (QMS) records are prepared.

4. License Application Submission (Form MD3): Once testing and documentation are complete, the formal application for the MD5 license is submitted through the CDSCO portal.

5. Audit by Notified Body: An essential step involves an audit by a notified body to verify compliance with regulatory and quality requirements. You can refer to the list of notified bodies authorized for Class B devices.

6. Query Resolution: Any queries raised by the licensing authority or notified body must be promptly addressed with supporting evidence.

7. Grant of MD5 License: Upon successful audit and document approval, the State Licensing Authority issues the MD5 manufacturing license.

The entire process typically spans 3 to 4 months, assuming timely test reports and audit scheduling.

Manufacturing License Documents Required for Urinary Stone Retrieval Basket

To ensure a smooth application, the following documents must be meticulously prepared and uploaded:

• Company Constitution Documents: Certificate of Incorporation, Memorandum and Articles of Association
• Proof of Ownership or Lease of Premises: Rent agreement or ownership documents
• Technical Staff Details: Qualification and experience certificates
• Fire NOC and Pollution Control NOC: From relevant authorities
• Device Master File (DMF): Detailed technical specifications, design, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment details, and quality procedures (Plant Master File Guide)
• Essential Principles Checklist: Compliance with safety and performance principles
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
• Test Reports: From government-approved testing labs
• Labels and Instructions for Use (IFU): Device labeling, packaging, and usage instructions
• Quality Management System Documents: ISO 13485 certification and related SOPs

Ensuring these documents are complete and accurate significantly reduces processing delays.

Import License Process (MD15) for Urinary Stone Retrieval Basket

For companies seeking to import urinary stone retrieval baskets into India, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority and typically takes 5 to 6 months.

Key steps include:

• Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and Wholesale License.
• Application Submission: Use Form MD14 on the CDSCO MD Online Portal.
• Query Resolution: Address any department queries promptly.
• Grant of MD15 License: Upon approval, the import license is issued.

Import licensing fees vary by device class and number of products. For Class B devices, fees are moderate compared to higher-risk classes.

Import License Documents Required

Documentation is critical for import license approval. Required documents include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate
• Device Master File and Plant Master File
• Wholesale license issued by State Authorities
• Company Constitution Documents

Detailed guidance on import licensing can be found in our Import License Guide.

Timeline and Processing Duration

Proactive planning and early submission of complete documents can expedite these timelines.

Government Fees and Costs

For the manufacturing license (MD5) of Class B devices like urinary stone retrieval baskets:

• Application Fee: INR 5,000 per application
• Per Product Fee: INR 500

For import licenses (MD15), fees are as follows (approximate):

• Class B device: INR 150,000 per site
• INR 50,000 per product

Additional costs include laboratory testing fees, notified body audit fees, and consulting charges if applicable.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or improper test reports.

Solution: Engage experienced consultants early to prepare and review documents. Use recommended government-approved labs for testing to avoid discrepancies.

Challenge: Scheduling audits with notified bodies can be time-consuming.

Solution: Contact multiple notified bodies in advance and select the one with availability aligned to your timeline. Refer to the list of notified bodies for options.

Challenge: Resolving departmental queries.

Solution: Maintain organized records and be prompt in providing clarifications with supporting evidence.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially with evolving regulations. Our team, with over 25 years of regulatory expertise, has successfully guided 500+ manufacturers and importers in obtaining MD5 and MD15 licenses for devices like urinary stone retrieval baskets. We offer:

• Regulatory gap analysis
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• Application submission and follow-up
• Post-approval compliance support

Partnering with experts ensures compliance, reduces risks, and accelerates market entry.

Getting Started with Your CDSCO License Application for Urinary Stone Retrieval Basket

To initiate your licensing journey, follow these practical steps:

1. Classify Your Device Accurately: Confirm the device classification as Class B based on the official notification.
2. Prepare Initial Documents: Gather company constitution, premises ownership, technical staff details, and quality system certifications.
3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal to begin manufacturing samples for testing.
4. Schedule Product Testing: Coordinate with government-approved labs to conduct mandatory tests.
5. Develop Device and Plant Master Files: Compile detailed technical and manufacturing information.
6. Engage a Notified Body: Select a notified body early to schedule audits.
7. Submit MD5 License Application (Form MD3): Once testing and documentation are ready, apply for the manufacturing license.
8. Respond to Queries Promptly: Address any department or audit observations without delay.

By meticulously following these steps and leveraging expert guidance, you can successfully obtain your CDSCO manufacturing license and ensure the urinary stone retrieval basket reaches the Indian market efficiently and compliantly.

For further assistance, feel free to consult our detailed MD5 License Guide and contact our regulatory team.