CDSCO License for Shunt thrombus suction set

Comprehensive Guide to CDSCO Licensing for Shunt Thrombus Suction Set (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like the Shunt Thrombus Suction Set. As a device used in nephrology and renal care to suction thrombus from arteriovenous shunts during hemodialysis, this Class B medical device requires adherence to specific CDSCO regulations to ensure patient safety and market compliance. With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide you with a detailed, practical roadmap tailored for this device.

CDSCO Regulatory Framework for Shunt Thrombus Suction Set

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. The Shunt Thrombus Suction Set falls under the notified device category per Notification 29/Misc./03/2020-DC (143) dated 13.9.2021, specifically under nephrology and renal care devices.

This device is classified as Class B under CDSCO’s risk classification system, indicating a low to moderate risk associated with its use. Consequently, the regulatory pathway involves obtaining a manufacturing license (MD5) from the State Licensing Authority if manufacturing domestically, or an import license (MD15) from the Central Licensing Authority if importing.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Shunt Thrombus Suction Set are subject to the MD5 licensing process. This falls under the jurisdiction of the State Licensing Authority and requires compliance with both quality and safety standards. The MD5 license application includes:

• Test license (Form MD13)
• Product testing by government-approved labs
• Device Master File and Plant Master File submissions
• Audit by a notified body
• Final grant of license (Form MD5)

For detailed classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Shunt Thrombus Suction Set

1. Apply for Test License (Form MD13): Initiate the process by applying for a test license on the CDSCO MD Online Portal. This license is valid for testing the device and normally takes 1.5 to 2 months to process.

2. Product Testing: After obtaining the test license, the device must be tested at a government-approved laboratory. The list of such labs can be accessed here. Testing validates conformance with Indian standards and essential principles.

3. Document Preparation: Compile all necessary technical and quality documents including Device Master File, Plant Master File, Risk Management File, and others as outlined below.

4. Application for Manufacturing License (Form MD3): Submit your application for the MD5 manufacturing license through the CDSCO portal.

5. Audit by Notified Body: A notified body from the official list (Notified Bodies List) will conduct an audit of your manufacturing premises and QMS.

6. Resolution of Queries: Address any queries from the licensing authority or notified body promptly.

7. Grant of Manufacturing License (Form MD5): Upon successful audit and document review, the MD5 license is granted.

For a step-by-step guide, explore our detailed MD5 License Guide.

Manufacturing License Documents Required

To ensure a smooth application process for your Shunt Thrombus Suction Set, prepare the following documents meticulously:

• Company Constitution: Incorporation certificates, partnership deed, or LLP agreements.
• Proof of Ownership or Lease of Manufacturing Premises: Land ownership or valid lease agreements.
• Technical Staff Documents: Qualifications and experience certificates of technical personnel.
• Fire and Pollution NOCs: Valid fire safety and pollution control clearances.
• Device Master File (DMF): Comprehensive technical description, design, manufacturing process details. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Details of the manufacturing facility, equipment, and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance with safety and performance standards.
• Risk Management File: Documentation of risk analysis and mitigation strategies. For in-depth insights, see our Risk Management guide.
• Test Reports: Product testing certificates from authorized labs.
• Labels and Instructions for Use (IFU): Samples and compliance with labeling requirements.
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs.

Import License Process (MD15) for Shunt Thrombus Suction Set

If you plan to import the Shunt Thrombus Suction Set into India, you must obtain an MD15 Import License from the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
• Application submission on the CDSCO MD Online Portal.
• Resolution of any authority queries.
• License grant (Form MD15).

The MD15 process typically takes 5-6 months.

For a detailed walkthrough, consult our Import License Guide.

Import License Documents Required

• Valid manufacturing license from country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale license for distribution
• Company Constitution documents

Timeline and Processing Duration

Planning ahead is critical. Delays often arise due to incomplete documentation or audit non-compliance.

Government Fees and Costs for Shunt Thrombus Suction Set

• MD5 Manufacturing License:

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

• Test License (MD13): Typically included in the above timeframe; specific fees vary.

• Import License (MD15):

  • Class B Device Fee: ₹2,000 per site
  • Product Fee: ₹1,000 per product

Budgeting for these fees upfront helps avoid unexpected financial bottlenecks.

Common Challenges and Solutions

Challenge: Delay in obtaining test reports from approved laboratories.

Solution: Engage with laboratories early and ensure your samples meet submission criteria. Reference the Testing Laboratories list to select accredited labs.

Challenge: Audit non-compliance due to documentation gaps.

Solution: Prepare a comprehensive Plant Master File and Device Master File as per guidelines. Use our PMF and DMF guides for thorough preparation.

Challenge: Query resolution delays.

Solution: Maintain a dedicated regulatory team or consultant to respond promptly to queries.

Expert Consultation and Support

With over 25 years of experience and a track record of assisting 500+ companies, we specialize in simplifying CDSCO licensing processes. Our expertise includes:

• End-to-end documentation preparation
• Liaison with notified bodies and CDSCO officials
• Audit readiness and gap analysis
• Post-license compliance support

Partnering with seasoned consultants can significantly reduce licensing timelines and ensure compliance.

Getting Started with Your CDSCO License Application for Shunt Thrombus Suction Set

1. Assess Your Device Classification: Confirm Class B status and licensing requirements.

2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the application process.

3. Prepare Initial Documentation: Begin compiling company constitution, premises proof, and technical staff details.

4. Apply for Test License (MD13): Initiate testing early to avoid delays.

5. Engage Accredited Testing Labs: Submit your samples promptly for testing.

6. Develop Comprehensive DMF and PMF: Use our guides to ensure quality and compliance.

7. Schedule Notified Body Audit: Coordinate early to align with your manufacturing timelines.

8. Submit Manufacturing License Application (MD3) for MD5: Complete your application with all supporting documents.

9. Prepare for Query Resolution: Assign a point person to handle CDSCO communications.

10. Obtain License and Commence Manufacturing: Once granted, maintain QMS and compliance for renewals.

We invite you to leverage our expertise to navigate the complexities of CDSCO licensing for your Shunt Thrombus Suction Set effectively. Contact us today to initiate your licensing journey and secure timely access to the Indian market.