CDSCO License for Flexible video cystourethroscope

Introduction to Flexible Video Cystourethroscope and Regulatory Importance

The flexible video cystourethroscope is a specialized urology medical device designed for the visual examination and treatment of the bladder, urethra, and prostate region. Its flexible inserted portion allows clinicians to navigate complex anatomical structures with precision, making it indispensable in endoscopic urological procedures. Given its direct clinical application and patient impact, regulatory compliance is critical to ensure safety, efficacy, and market access in India.

With over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the nuances involved in obtaining regulatory approval for such Class B devices. This comprehensive guide will help manufacturers and importers navigate the regulatory landscape efficiently.

CDSCO Regulatory Framework for Flexible Video Cystourethroscope

Under the Drugs and Cosmetics Act and Medical Device Rules, the flexible video cystourethroscope falls under the urology category and is classified as a Class B medical device. The Central Drugs Standard Control Organization (CDSCO) regulates its manufacture and import to uphold stringent safety and performance standards.

The device is specifically notified under File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, aligning it with the latest regulatory requirements for medical devices in India.

Risk Classification and License Requirements

Being a Class B device, the flexible video cystourethroscope requires a Manufacturing License MD5, issued by the State Licensing Authority. This license applies to manufacturers and involves a thorough review process including testing, audit, and documentation verification.

For importers, a separate Import License MD15 issued by the Central Licensing Authority is mandatory.

Detailed device classification can be cross-checked via the Medical Device Classification guide.

Manufacturing License Process (MD5) for Flexible Video Cystourethroscope

The MD5 license process for this Class B device typically spans 3 to 4 months and involves the following phases:

1. Test License (Form MD13): Apply for a test license to manufacture and test the device samples. This phase usually takes 1.5 to 2 months.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories. Refer to the list of testing laboratories.
3. Documentation Preparation: Compile required documents including Device Master File, Plant Master File, Risk Management File, and others.
4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for an audit. Check the list of notified bodies authorized for MD5 audits.
6. Query Resolution: Address any queries raised by the department or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory audit and documentation review, the license is granted.

For an in-depth walkthrough, our MD5 License Guide offers practical insights.

Manufacturing License Documents Required

The following documents are essential for the MD5 license application for a flexible video cystourethroscope:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Qualification and experience details of technical staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design and specifications (Guide here)
• Plant Master File (PMF) showing manufacturing capabilities (Guide here)
• Essential Principles Checklist demonstrating compliance
• Risk Management File highlighting hazard analysis and mitigation (Risk Management resource)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process (MD15) for Flexible Video Cystourethroscope

If you are an importer of flexible video cystourethroscopes, you must obtain an Import License MD15 from the Central Licensing Authority. This process generally takes 5 to 6 months and involves:

1. Document Preparation: Collect all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and others.
2. Application Submission (Form MD14): Apply through the CDSCO MD Online Portal.
3. Query Resolution: Respond to any departmental queries.
4. Grant of License (Form MD15): On approval, licensing is granted allowing import.

For detailed assistance, refer to our Import License Guide.

Import License Documents Required

Key documents for MD15 import license include:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale license for distribution in India
• Company Constitution and registration documents

Timeline and Processing Duration

The timeline can vary based on the completeness of documentation, audit scheduling, and query resolution speed.

Government Fees and Costs

For a Class B device like the flexible video cystourethroscope, the fee structure is as follows:

• MD5 Manufacturing License:

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• MD15 Import License:

  • Site fee: $2,000 (approx Rs 1,60,000)
  • Per product fee: $1,000 (approx Rs 80,000)

These fees are payable online via the CDSCO portal during application submission.

Common Challenges and Solutions

• Delayed Test Reports: Ensure early coordination with CDSCO-approved labs to avoid bottlenecks. Always verify lab accreditation before sample submission.
• Incomplete Documentation: Use comprehensive checklists and templates, such as those found in our Device Master File and Plant Master File guides, to ensure no gaps.
• Audit Findings: Prepare meticulously for audits by conducting internal pre-audits and training staff on QMS and compliance requirements.
• Regulatory Updates: Stay updated on notifications like File No. 29/Misc./03/2020-DC (145) dated 23.8.2021 to align with current standards.

Expert Consultation and Support

Navigating the CDSCO licensing process for sophisticated devices like the flexible video cystourethroscope demands expert guidance. We offer tailored consultation addressing:

• Regulatory strategy and classification
• Documentation support including DMF, PMF, and Risk Management
• Liaison with notified bodies and CDSCO officials
• Post-approval compliance and vigilance

Our extensive experience ensures a streamlined licensing journey, reducing time and cost overheads.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device falls under Class B using official resources.
2. Initiate Test License: Apply for Form MD13 via the CDSCO MD Online Portal to begin manufacturing test samples.
3. Engage Approved Labs: Schedule product testing early to accommodate timelines.
4. Prepare Documentation: Utilize our Device and Plant Master File guides to assemble robust files.
5. Schedule Audit: Select a notified body from the official list for your MD5 audit.
6. Submit Application: File your manufacturing license application (Form MD3) online.
7. Respond to Queries Promptly: Maintain open communication to expedite processing.

By following these practical steps, manufacturers and importers can confidently pursue CDSCO licensing for flexible video cystourethroscopes, ensuring timely market entry and compliance.

For personalized assistance or to discuss your project, please contact our regulatory experts. Together, we can make your regulatory journey seamless and successful.