CDSCO License for Non-vascular catheter introduction set

Comprehensive Guide to CDSCO Licensing for Non-vascular Catheter Introduction Set (Class B)

Navigating the regulatory landscape for medical devices in India requires in-depth knowledge and practical experience. With over 25 years in medical device regulatory consulting and having assisted 500+ companies, we provide you with an expert roadmap to obtain the CDSCO license for your Non-vascular Catheter Introduction Set, a Class B device used in gastroenterology.

Introduction to Non-vascular Catheter Introduction Set and Its Regulatory Importance

The Non-vascular Catheter Introduction Set is a crucial sterile, invasive medical device designed for percutaneous Seldinger-type insertion of drainage catheters into body cavities such as the biliary tract or ureter. Given its invasive nature and involvement in critical body areas, regulatory oversight ensures safety, quality, and efficacy before market entry.

The Central Drugs Standard Control Organization (CDSCO) governs such devices under the Medical Device Rules, 2017 (amended 2020), where this device falls under Class B (low-moderate risk). Obtaining the appropriate manufacturing license is mandatory to legally market and distribute this device in India.

CDSCO Regulatory Framework for Non-vascular Catheter Introduction Set

Per the CDSCO notification 29/Misc./03/2020-DC (182) dated 27.09.2021, the Non-vascular Catheter Introduction Set is classified as a Class B device. Devices in this category require a manufacturing license under Form MD5, issued by the State Licensing Authority following specific compliance and audit procedures.

The Medical Device Rules emphasize conformity with essential principles, quality management systems, and comprehensive documentation to ensure device safety.

Risk Classification and License Requirements for Class B Devices

Class B devices represent low to moderate risk. The regulatory requirements include:

• Test License (Form MD13): Mandatory initial step to allow product testing.
• Product Testing: Performed at CDSCO-approved government laboratories.
• Manufacturing License (Form MD3 for MD5 License): Application submitted post testing and audit.
• Audit: Conducted by CDSCO-notified bodies to verify compliance.

For detailed classification reference, see our Medical Device Classification guide.

Manufacturing License Process (MD5) for Non-vascular Catheter Introduction Set

The MD5 license is granted by the State Licensing Authority and involves the following sequential steps:

1. Apply for Test License (Form MD13): Submit your application through the CDSCO MD Online Portal. This takes approximately 1.5 to 2 months.
2. Product Testing: Once the test license is granted, submit samples to government-approved testing laboratories. Refer to the List of Testing Laboratories for accredited labs.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and more.
4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license after successful testing.
5. Audit by Notified Body: The notified body conducts facility and quality system audits. Check the list of notified bodies for registered auditors.
6. Resolution of Queries: Address any observations or queries raised during the audit or by the licensing authority promptly.
7. Grant of License (Form MD5): Upon satisfactory compliance, the license is issued.

This entire process typically spans 3 to 4 months.

Manufacturing License Documents Required for MD5

To ensure a smooth application, prepare the following comprehensive documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Proof
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, manufacturing processes, and design controls. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Details of manufacturing facilities and quality systems. Learn how to create an effective PMF here: Plant Master File Guide.
• Essential Principles Checklist: Demonstrate conformity with Indian regulatory essential principles.
• Risk Management File: Document risk analysis and mitigation strategies per ISO 14971. For practical guidance, visit our Risk Management resource.
• Test Reports: From CDSCO-approved laboratories.
• Labels and Instructions for Use (IFU): Compliant with Indian labeling regulations.
• Quality Management System (QMS) Documents: Usually ISO 13485:2016 certification.

Import License Process (MD15) for Non-vascular Catheter Introduction Set

If you plan to import the Non-vascular Catheter Introduction Set into India, an import license under Form MD15 is mandatory. This is granted by the Central Licensing Authority and involves:

• Document preparation including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, and Wholesale License.
• Submission of application via the CDSCO MD Online Portal.
• Resolution of departmental queries.

The import license process generally takes 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Incorporation Documents

For more detailed steps, please review our Import License Guide.

Timeline and Processing Duration

Import licensing extends to approximately 5-6 months due to central authority oversight.

Government Fees and Costs

For Class B devices like the Non-vascular Catheter Introduction Set, the fees are as follows:

• MD5 Manufacturing License:

  • Rs 5,000 per application
  • Rs 500 per product

• Import License (MD15):

  • Rs 1,000 per product
  • Rs 2,000 per site (approximate, varies by product category)

Additional costs include testing fees at government labs and audit charges by notified bodies.

Common Challenges and Solutions

• Delayed Testing Results: Plan sample submissions early and maintain communication with testing labs.
• Incomplete Documentation: Utilize detailed checklists and consult experienced regulatory professionals to avoid rejections.
• Audit Non-compliance: Pre-audit internal assessments are critical. Ensure your QMS and facility meet CDSCO requirements.
• Query Resolution Delays: Respond promptly with clear, evidence-backed replies.

Our real-world experience shows proactive planning and expert consultation drastically reduce approval times.

Expert Consultation and Support

With two and a half decades of regulatory expertise, we guide manufacturers through every CDSCO licensing step. From drafting Device Master Files to managing audits and resolving queries, our tailored services help you achieve timely approvals.

Getting Started with Your CDSCO License Application

To embark on your licensing journey for the Non-vascular Catheter Introduction Set:

1. Register your company on the CDSCO MD Online Portal.
2. Initiate the Test License (MD13) application immediately.
3. Prepare your product samples for testing in advance.
4. Begin compiling mandatory documentation using our linked resources.
5. Schedule an audit with a notified body post testing – consult the Notified Bodies List to select an auditor.

By following these actionable steps, you place your business on a path to regulatory compliance and successful market entry in India’s growing medical device sector.