CDSCO License for Rigid ureteroscope

Introduction to Rigid Ureteroscope and Regulatory Importance

Rigid ureteroscopes are essential urological devices designed for the visual examination and treatment of the ureter, connecting the kidney to the bladder. Given its invasive use in the upper urinary tract, ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) regulations is critical for patient safety and market authorization in India. With over 25 years of experience assisting 500+ companies in navigating the CDSCO licensing landscape, we understand the nuances involved in obtaining the necessary approvals for Class B medical devices like rigid ureteroscopes.

CDSCO Regulatory Framework for Rigid Ureteroscopes

The CDSCO regulates medical devices under the Medical Device Rules, 2017, which classify devices into four risk classes (A to D). The rigid ureteroscope falls under Class B due to its moderate risk profile. Regulatory oversight for Class B devices is primarily managed by the State Licensing Authority through the issuance of an MD5 manufacturing license. This ensures that manufacturers meet stringent quality, safety, and performance standards before marketing.

Risk Classification and License Requirements for Rigid Ureteroscope

• Device Name: Rigid Ureteroscope
• Risk Class: B (Moderate risk)
• Intended Use: Visual examination and treatment of the ureter
• Category: Urology
• Notification Reference: File No. 29/Misc./03/2020-DC (145), dated 23.8.2021

Class B devices require an MD5 manufacturing license issued by the State Licensing Authority. Manufacturers must first obtain a Test License (MD13), conduct product testing at CDSCO-approved labs, undergo an audit by a notified body, and finally apply for the manufacturing license.

Manufacturing License Process (MD5) for Rigid Ureteroscope

The MD5 license process involves multiple critical steps:

1. Apply for Test License (Form MD13): Initiate by applying for a test license to manufacture the rigid ureteroscope for testing purposes. This takes approximately 1.5 to 2 months.
2. Product Testing: Get the product tested at government-approved laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories recognized by CDSCO.
3. Documentation Preparation: Prepare detailed technical documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Apply for MD5 License (Form MD3): Following successful testing, submit the application for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit will be conducted by a notified body authorized for Class B devices. See the notified bodies list to select an appropriate auditor.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory completion of all requirements, the license is granted on Form MD5.

For a detailed guide, our MD5 License Guide provides step-by-step instructions.

Manufacturing License Documents Required

The following documents must be meticulously prepared and submitted:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining identified hazards and mitigation strategies (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Ensuring completeness and accuracy of these documents significantly reduces delays during the audit and review stages.

Import License Process (MD15) for Rigid Ureteroscope

For importers of rigid ureteroscopes, CDSCO mandates obtaining an MD15 import license issued by the Central Licensing Authority. The import process involves:

1. Document Preparation: Assemble key documents including the valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Apply for Import License (Form MD14): Submit the application via the CDSCO MD Online Portal.
3. Queries Resolution: Respond to any clarifications or additional requirements raised by the licensing authority.
4. Grant of License: The import license (Form MD15) is issued, typically within 5-6 months.

Refer to our comprehensive Import License Guide for nuanced insights.

Import License Documents Required

• Valid Manufacturing License of the product from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License for distribution
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

The entire manufacturing license process can take approximately 3 to 4 months post-testing. Import licenses generally require 5 to 6 months.

Government Fees and Costs

• MD5 License (Class B): Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Fees vary; often included with MD5 application

Note: Fees are payable through the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

• Delayed Test Reports: Testing at CDSCO-approved labs can be a bottleneck. Pre-book slots and follow up proactively.
• Incomplete Documentation: Missing or inconsistent documents cause audit failures. Utilize checklists and expert reviews.
• Audit Non-Compliance: Prepare thoroughly for notified body audits by conducting internal pre-audits.
• Queries from CDSCO: Respond promptly with clear, evidence-backed explanations.

Our experience shows manufacturers who invest time in detailed documentation and engage qualified consultants face fewer hurdles.

Expert Consultation and Support

With over two decades of expertise and a successful track record assisting 500+ companies, we provide end-to-end support, including:

• Regulatory strategy and classification
• Documentation preparation (DMF, PMF, Risk Management)
• Coordination with notified bodies and laboratories
• Application filing and query management
• Post-approval compliance guidance

Engaging expert consultants can reduce approval time and avoid costly rejections.

Getting Started with Your CDSCO License Application for Rigid Ureteroscope

1. Confirm Device Classification: Verify your device is Class B as per Medical Device Classification.
2. Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
3. Select Testing Laboratory: Coordinate with CDSCO-approved labs early to schedule product testing.
4. Prepare Comprehensive Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.
5. Plan for Notified Body Audit: Choose a notified body from the Notified Bodies List and prepare for audit.
6. Submit Manufacturing License Application (Form MD3): Upon successful testing and preparation, apply for the MD5 license.
7. Respond to Queries Promptly: Maintain clear communication with CDSCO and the notified body.

By following these actionable steps, manufacturers and importers can efficiently navigate the regulatory pathway for rigid ureteroscopes and enter the Indian market with confidence.