CDSCO License for Flexible video ureterorenoscope, reusable

Introduction to Flexible Video Ureterorenoscope and Regulatory Importance

The Flexible Video Ureterorenoscope, reusable, is a sophisticated urology device designed for minimally invasive visual examination and treatment of the ureter and renal pelvis. Given its invasive application and reusable nature, regulatory compliance is critical to ensure patient safety and market access. In India, this device falls under Risk Class B as per the CDSCO classification, necessitating a stringent licensing process to meet quality and safety standards.

As regulatory consultants with over 25 years of experience, having assisted more than 500 companies, we understand the nuances of navigating the CDSCO framework effectively. This guide provides a comprehensive roadmap for manufacturers and importers seeking the MD5 manufacturing license and import permissions required to market this device in India.

CDSCO Regulatory Framework for Flexible Video Ureterorenoscope

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Flexible Video Ureterorenoscope is classified as a Class B device—a low to moderate risk category—which requires a state-level manufacturing license (MD5) and central import license (MD15) for importers.

This device is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, aligning with the government’s regulatory updates to ensure all urological endoscopes meet prescribed safety and performance criteria.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk, requiring:

• MD5 Manufacturing License: Granted by the State Licensing Authority.
• Test License (MD13): Mandatory initial test license before MD5 application.
• Product Testing: Testing at government-approved labs.
• Audit by Notified Body: To verify compliance with quality systems and manufacturing premises.

Manufacturers must prepare detailed documentation including Device Master Files, Plant Master Files, and Risk Management Files. Importers require MD15 import license from CDSCO Central Licensing Authority.

For more on classification, see our Medical Device Classification guide.

Manufacturing License Process (MD5) for Flexible Video Ureterorenoscope

1. Obtain Test License (Form MD13): Initial step taking approximately 1.5 to 2 months, allowing sample testing.
2. Product Testing: Conducted at CDSCO-recognized labs; refer to the Testing Laboratories list.
3. Prepare Documentation: Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and others.
4. Application Submission (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit to verify compliance; find notified bodies on the Notified Bodies List.
6. Resolve Queries: Respond promptly to any queries from CDSCO or notified body.
7. Grant of License (Form MD5): Upon successful audit and review.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for Flexible Video Ureterorenoscope

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association.
• Proof of Premises Ownership or Lease: Valid legal documentation.
• Technical Staff Details: CVs and qualifications of key personnel.
• Fire and Pollution NOCs: Compliance certificates.
• Device Master File (DMF): Comprehensive technical specifications and design; refer to our Device Master File guide.
• Plant Master File (PMF): Details of manufacturing facility and processes; see our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with Indian regulations.
• Risk Management File: Documenting hazard identification and mitigation strategies; more at our Risk Management resource.
• Government Test Reports: From CDSCO approved labs.
• Labels and IFU (Instructions for Use): Compliant with CDSCO guidelines.
• Quality Management System Documents: ISO 13485 certification and internal SOPs.

Import License Process (MD15) for Flexible Video Ureterorenoscope

Importers must obtain an MD15 license from the CDSCO Central Licensing Authority. Unlike manufacturing, test licenses are not required for import.

1. Document Preparation: Including manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files.
2. Submit Application (Form MD14): Via the CDSCO MD Online Portal.
3. Respond to Queries: Prompt and complete responses expedite approval.
4. License Grant (Form MD15): Typically issued within 5-6 months.

Import License Documents Required

• Valid Manufacturing License (MD5 or MD9) from the country of origin.
• Free Sale Certificate from the regulatory body of the exporting country.
• ISO 13485:2016 Certification.
• CE Certificate (if applicable).
• Device Master File.
• Plant Master File.
• Wholesale License.
• Company Constitution Documents.

Timeline and Processing Duration

Manufacturers should anticipate a total of approximately 4-5 months from test license application to MD5 license grant.

Government Fees and Costs for Flexible Video Ureterorenoscope (Class B)

• MD5 License: ₹5,000 per application + ₹500 per product.
• Test License (MD13): Fees as per CDSCO norms.
• Import License (MD15): ₹2,000 per site + ₹1,000 per product.

Budgeting for these fees early in your project planning is critical to avoid delays.

Common Challenges and Solutions

Challenge: Delay in test report generation due to limited slots at government labs.

Solution: Schedule testing early and consider accredited third-party labs recognized by CDSCO.

Challenge: Documentation gaps leading to audit non-conformities.

Solution: Utilize expert consultants to prepare comprehensive Device and Plant Master Files and conduct internal pre-audits.

Challenge: Misclassification of device risk leading to incorrect license application.

Solution: Confirm classification with CDSCO guidelines or through a regulatory expert.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for intricate devices like the Flexible Video Ureterorenoscope. Our team’s extensive experience enables efficient management of documentation, audit preparation, and query resolution, minimizing approval timelines and ensuring compliance.

We offer tailored services including risk classification assistance, technical document preparation, liaison with notified bodies, and strategic regulatory planning.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm Class B status.
2. Initiate Test License (MD13) application: Submit through the CDSCO MD Online Portal.
3. Engage with CDSCO-approved testing labs early: Secure testing slots promptly.
4. Prepare comprehensive documentation: Follow templates and guides for Device and Plant Master Files.
5. Plan notified body audit: Schedule audit after test reports are received.
6. Submit MD5 license application (Form MD3): After audit readiness.
7. Address queries promptly: Facilitate smooth clearance.

Starting early and engaging expert support can significantly streamline your licensing journey. Contact us to leverage our 25+ years of regulatory expertise and ensure your Flexible Video Ureterorenoscope enters the Indian market with full compliance and confidence.