CDSCO License for Flexible fibreoptic ureterorenoscope

Introduction to Flexible Fibreoptic Ureterorenoscope and its Regulatory Importance

Flexible fibreoptic ureterorenoscopes play a vital role in urology, enabling minimally invasive visual examination and treatment of the ureter and renal pelvis. Given their critical function, regulatory compliance is essential to ensure patient safety and market access within India. As experts with over 25 years and 500+ successful CDSCO license applications, we understand the nuances of obtaining approvals for Class B devices like flexible ureterorenoscopes.

CDSCO Regulatory Framework for Flexible Fibreoptic Ureterorenoscopes

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Flexible fibreoptic ureterorenoscopes fall under the urology category, classified as Class B devices per the official notification (File No. 29/Misc./03/2020-DC (145), dated 23.8.2021).

Class B devices require a State Licensing Authority-issued MD5 manufacturing license for domestic manufacturers or an MD15 import license for importers. This regulatory pathway ensures conformity with safety, efficacy, and quality standards.

Risk Classification and License Requirements for Flexible Fibreoptic Ureterorenoscopes

Being a Class B device, flexible fibreoptic ureterorenoscopes require:

• Manufacturing License (MD5) for domestic production.
• Import License (MD15) for imported devices.

The MD5 license is granted by the State Licensing Authority and involves a multi-step process including test license acquisition, product testing, audit by notified bodies, and submission via the CDSCO MD Online Portal.

Manufacturing License Process (MD5) for Class B Devices

Manufacturers must first obtain a test license on Form MD13, valid for 12 months, to allow initial product testing. The test license application typically takes 1.5 to 2 months to process. After product testing at government-approved laboratories, manufacturers apply for the MD5 license using Form MD3.

The process includes an audit by a notified body listed on the CDSCO Notified Bodies List. Following audit and resolution of any queries, the State Licensing Authority grants the MD5 license on Form MD5.

Manufacturing License Documents Required for Flexible Fibreoptic Ureterorenoscope

For a smooth application, the following documents are essential:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Detailed Profiles of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design and manufacturing processes (Device Master File Guide)
• Plant Master File describing infrastructure and quality systems (Plant Master File Guide)
• Essential Principles Checklist affirming compliance with medical device rules
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories)
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Flexible Fibreoptic Ureterorenoscopes

Importers seeking to bring flexible fibreoptic ureterorenoscopes into India must apply for the MD15 license through the Central Licensing Authority. Unlike manufacturing, import licensing does not require a test license but demands comprehensive documentation.

The application process involves submission on the CDSCO MD Online Portal, followed by scrutiny and query resolution. Once compliant, the MD15 license is issued, enabling lawful importation.

Import License Documents Required

Key documents for MD15 license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international regulatory approval
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

• Manufacturing License (MD5): Approximately 3 to 4 months, including 1.5 to 2 months for the Test License (Form MD13) and product testing.
• Import License (MD15): Approximately 5 to 6 months.

These timelines reflect typical processing periods but may vary based on query resolution speed and audit scheduling.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product.
• Test License (MD13): Included within the MD5 process.
• MD15 Import License:
  • Class B devices attract Rs 2,000 per site + Rs 1,000 per product.

Budgeting for notified body audits and testing lab fees is also crucial. For notified body audits, refer to the CDSCO Notified Bodies List for fee estimates.

Common Challenges and Solutions

• Delays in Test Reports: Testing at government-approved labs can be time-consuming. Early engagement and submission of all relevant samples help avoid delays.
• Incomplete Documentation: Missing or inconsistent documents cause rejections. Using comprehensive checklists like our Device Master File guide ensures completeness.
• Audit Non-Compliance: Preparing thoroughly for notified body audits by maintaining robust QMS and facility readiness is key.
• Technical Staff Qualifications: Ensure technical team credentials meet CDSCO requirements to avoid audit issues.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ medical device companies, we provide end-to-end support—from initial classification and documentation to regulatory submissions and audit preparedness. Our tailored guidance mitigates risks of application rejections and accelerates market entry.

Getting Started with Your CDSCO License Application for Flexible Fibreoptic Ureterorenoscopes

1. Verify Device Classification: Confirm Class B status using CDSCO resources or our Medical Device Classification guide.
2. Prepare Documentation: Begin compiling the Device Master File, Plant Master File, and supporting documents as per the checklists.
3. Submit Test License Application: Apply for Form MD13 test license via the CDSCO MD Online Portal.
4. Arrange Product Testing: Coordinate with CDSCO-approved testing labs early to schedule testing.
5. Plan for Audit: Select a notified body from the Notified Bodies List and prepare your facility and QMS.
6. File MD5 License Application: Upon successful testing and audit readiness, submit Form MD3 for manufacturing license.

For importers, begin with document compilation and submit your MD15 application directly, ensuring adherence to the import license requirements.

Embarking on the CDSCO licensing journey for flexible fibreoptic ureterorenoscopes is complex but manageable with expert guidance. Contact us to streamline your regulatory process and confidently enter the Indian medical device market.