CDSCO License for Depezzer Catheter

Comprehensive Guide to CDSCO Licensing for Depezzer Catheter (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for catheter manufacturers and importers. The Depezzer Catheter, a flexible tubular instrument designed for fluid withdrawal from body cavities, falls under Risk Class B as per CDSCO regulations. With over 25 years of regulatory consulting experience and having assisted 500+ companies, we provide you with an expert-level roadmap to expedite your CDSCO licensing process—minimizing delays and ensuring compliance.

Understanding the Regulatory Importance of CDSCO Licensing for Catheters

Catheters like the Depezzer are critical medical devices used extensively in clinical settings. Ensuring their safety, efficacy, and quality is paramount. The Central Drugs Standard Control Organization (CDSCO) governs the licensing and regulatory approval of such devices in India, in alignment with the Medical Device Rules, 2017.

Obtaining the correct license not only legalizes your product’s manufacture and sale but also builds trust among healthcare providers and patients. The notification 29/Misc/3/2017-DC (292) dated 06.06.2018 specifically governs devices like catheters under Class B.

CDSCO Regulatory Framework for Depezzer Catheter

The Depezzer Catheter is categorized under Class B, indicating a moderate risk level. Under the Medical Device Rules, Class B devices require a manufacturing license granted by the State Licensing Authority via an MD5 license (Form MD3 application).

The entire approval process incorporates multiple steps including obtaining a test license (MD13), product testing, audit by a notified body, and final license grant. This ensures comprehensive scrutiny of your manufacturing setup and product quality.

Risk Classification and License Requirements for Class B Catheters

• Risk Class: B (Moderate risk)
• License Required: Manufacturing License MD5 (State Authority)
• Application Form: MD3
• Test License Form: MD13 (mandatory before MD5)

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

Manufacturing License Process for Depezzer Catheter (MD5 License)

1. Apply for Test License (Form MD13): Initiate with a test license application for your catheter at the state authority. This allows you to manufacture the device for testing purposes.
2. Product Testing: Submit samples to government-approved testing laboratories. The CDSCO list of testing laboratories includes recognized facilities for compliance analysis.
3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
4. Apply for Manufacturing License (Form MD3): After successful testing, apply for the MD5 license.
5. Audit by Notified Body: The manufacturing facility undergoes an audit by an approved notified body. Check the list of notified bodies for eligible auditors.
6. Resolve Queries: Address any observations or queries raised during the audit or by the CDSCO.
7. License Grant: Upon satisfactory compliance, the MD5 license is granted, formally authorizing manufacturing.

For an in-depth walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required for Depezzer Catheter

• Company Constitution (Incorporation documents)
• Proof of Premises Ownership or Lease Agreement
• Details and qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF) covering design, materials, manufacturing method (Device Master File Guide)
• Plant Master File (PMF) detailing production facilities (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File articulating hazard analysis and mitigation (Risk Management Guide)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485:2016 compliance preferred)

Import License Process for Depezzer Catheter (MD15 License)

If you plan to import the Depezzer Catheter instead of manufacturing locally, you must apply for an import license (MD15) through the Central Licensing Authority.

Process steps include:

• Preparation of required documents
• Submission of application via Form MD14
• Responding to any departmental queries
• License issuance

Unlike manufacturing licenses, no test license (MD13) is required before applying for MD15.

For further assistance, our Import License Guide offers detailed procedural insights.

Import License Documents Required

• Valid Manufacturing License of the exporting company
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File
• Plant Master File
• Wholesale License for distribution in India
• Company Constitution and incorporation documents

Timeline and Processing Duration for Depezzer Catheter Licensing

Overall, expect around 3-4 months for manufacturing licenses and 5-6 months for import licenses. Early preparation and complete documentation are key to avoiding delays.

Government Fees and Costs for Depezzer Catheter License

• MD5 Manufacturing License:
  • Application Fee: Rs 5,000 per application
  • Product Fee: Rs 500 per product
• MD13 Test License: Included within manufacturing license process, fees vary by state

These fees are payable online via the CDSCO MD Online Portal.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. We recommend using checklists and expert review before submission.
• Delayed Product Testing: Choosing government-approved laboratories with quicker turnaround times reduces bottlenecks.
• Audit Preparedness: Early engagement with notified bodies and mock audits can help identify gaps before official inspection.
• Query Resolution: Designate a dedicated regulatory liaison to respond swiftly to queries from CDSCO or auditors.

Expert Consultation and Support

With our extensive experience guiding over 500 medical device companies, we provide tailored consulting to streamline your CDSCO licensing journey. Our services include document preparation, mock audits, product testing coordination, and liaison with regulatory authorities.

Getting Started with Your CDSCO License Application for Depezzer Catheter

1. Register on the CDSCO MD Online Portal. This is the mandatory platform for all applications.
2. Initiate Test License Application (Form MD13) with complete documentation. Prepare parallel submission to testing labs.
3. Coordinate with notified bodies early to schedule audits immediately after test license approval.
4. Consolidate your Device Master File and Plant Master File leveraging expert templates to ensure compliance.
5. Maintain continuous communication with CDSCO officials to promptly address any queries.

Embarking on this process with structured planning and expert guidance dramatically improves your chances of timely licensing approval for the Depezzer Catheter.

For personalized support tailored to your manufacturing or import needs, reach out to our regulatory consultants today and benefit from our proven track record in medical device licensing across India.