CDSCO License for Filiform urethral bougie
Medical Device Information
Intended Use
An extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately- threaded urethral catheter.

Introduction to Filiform Urethral Bougie and Regulatory Importance
Filiform urethral bougies are essential urological devices designed as thin, wire-like surgical instruments used to navigate and dilate urethral strictures. Given their direct application in delicate procedures involving the urinary tract, ensuring their quality and compliance with regulatory standards is critical for patient safety and clinical efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) oversees the regulation of such medical devices, mandating licenses before manufacturing or importing.
Understanding the regulatory landscape for this Class B medical device is vital for manufacturers and importers aiming to enter or expand within the Indian market. With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide a comprehensive, step-by-step guide tailored specifically for the Filiform urethral bougie.
CDSCO Regulatory Framework for Filiform Urethral Bougie
The CDSCO regulates medical devices under the Medical Device Rules, 2017, classifying them based on risk. The Filiform urethral bougie falls under Class B (low moderate risk), given its invasive nature but relatively lower risk compared to Class C or D devices. This risk classification influences the licensing authority, application process, documentation, and audit requirements.
The regulatory notification governing this device is File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, which formalizes its classification and regulatory requirements.
Risk Classification and License Requirements for Filiform Urethral Bougie
Being a Class B device, the manufacturing license for the Filiform urethral bougie must be obtained via the MD5 license process under the State Licensing Authority. This classification mandates:
- Submission of application using Form MD3 for manufacturing
- Obtaining a preliminary Test License (Form MD13)
- Product testing in CDSCO-approved laboratories
- Audit by a notified body
This pathway is designed to ensure robust quality control while facilitating timely market access.
Manufacturing License Process (MD5) for Filiform Urethral Bougie
The MD5 license process involves a series of well-defined steps:
Test License Application (Form MD13): Secure a test license to manufacture the device for testing purposes. This step typically requires 1.5 to 2 months for approval.
Product Testing: Conduct testing of the Filiform urethral bougie at CDSCO-recognized testing laboratories to verify compliance with essential principles and performance standards. Refer to the Testing Laboratories list for approved facilities.
Documentation Preparation: Compile technical documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
License Application Submission (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit by a notified body authorized for Class A and B devices. You may consult the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any observations or queries from the notified body or CDSCO within stipulated timelines.
Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.
Manufacturing License Documents Required for Filiform Urethral Bougie
Manufacturers must prepare a comprehensive set of documents, including:
- Company Constitution Documents: Incorporation certificate, partnership deed, Memorandum and Articles of Association
- Proof of Ownership/Lease of Manufacturing Premises: Valid rental agreement or ownership documents
- Technical Staff Details: Qualifications and experience certificates of manufacturing and quality control personnel
- No Objection Certificates: Fire NOC, Pollution Control Board NOC
- Device Master File (DMF): Detailed description, design, manufacturing process, and specifications of the Filiform urethral bougie. For guidance, see our Device Master File guide.
- Plant Master File (PMF): Information on manufacturing facilities, machinery, and environment. Learn more from our Plant Master File guide.
- Essential Principles Checklist: Demonstrating compliance with regulatory safety and performance standards
- Risk Management File: Documenting risk analysis and mitigation strategies. Implement best practices from our Risk Management resource.
- Test Reports: Certificates and reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU): Compliant with labeling requirements
- Quality Management System Documents: ISO 13485 certification and related SOPs
Import License Process (MD15) for Filiform Urethral Bougie
If you are an importer, the process involves obtaining the MD15 license from the Central Licensing Authority. Key steps include:
- Preparation of all required documents, including a valid Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Submission of application using Form MD14 via the CDSCO MD Online Portal
- Resolution of queries raised by CDSCO
- Grant of MD15 Import License
Unlike manufacturing, no test license is required for import. The entire process typically takes 5-6 months.
Import License Documents Required for Filiform Urethral Bougie
Importers must submit:
- Valid manufacturing license of the device in the country of origin
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification evidencing QMS
- CE Certificate or equivalent conformity assessment
- Device Master File and Plant Master File
- Wholesale license
- Company incorporation documents
Timeline and Processing Duration
For manufacturing the Filiform urethral bougie (Class B device) in India, the estimated timeline is:
- Test License Approval: 1.5 to 2 months
- Product Testing: 1 to 1.5 months
- Audit and License Processing: 1 to 1.5 months
Total: Approximately 3 to 4 months from start to finish
For importers applying for MD15, expect 5 to 6 months due to detailed document verification.
Government Fees and Costs
For MD5 manufacturing license (Class B):
- Application Fee: INR 5,000 per application
- Per Product Fee: INR 500 per product
Additional costs include testing fees at approved labs and audit charges by the notified body.
For MD15 import license fees vary by device class; Class B devices attract around USD 2,000 per site and USD 1,000 per product.
Common Challenges and Solutions
Challenge 1: Delays in test license approval. Solution: Submit complete and error-free test license applications with all supporting documents to avoid back-and-forth.
Challenge 2: Incomplete technical documentation. Solution: Utilize expert guidance to prepare thorough Device Master and Plant Master Files to preempt audit observations.
Challenge 3: Audit non-compliance. Solution: Conduct internal pre-audits and gap assessments before official audits to ensure readiness.
Challenge 4: Query resolution delays. Solution: Respond promptly and accurately to CDSCO queries with proper evidence to expedite approvals.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex. With over 25 years of regulatory consultancy experience assisting 500+ companies, we provide end-to-end support including:
- Regulatory strategy formulation
- Documentation preparation and review
- Coordination with notified bodies and CDSCO authorities
- Pre-audit training and internal audits
- Post-approval compliance support
Our expertise ensures your Filiform urethral bougie obtains timely market authorization with minimal hassle.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device as Class B using the Medical Device Classification resource.
Prepare Documentation: Begin compiling your Device Master File and Plant Master File. Refer to our guides for detailed steps.
Apply for Test License (Form MD13): Submit your test license application through the CDSCO MD Online Portal.
Plan Product Testing: Schedule tests at CDSCO-approved laboratories.
Engage a Notified Body: Identify and liaise with a notified body from the official list early to align audit timelines.
Submit Manufacturing License Application (Form MD3): Once testing and documents are ready, apply for the MD5 license.
Prepare for Audit: Conduct internal checks and training to ensure audit readiness.
Respond to Queries Promptly: Maintain open communication channels with CDSCO and auditors.
By following these practical steps and leveraging our extensive regulatory expertise, manufacturers and importers can confidently navigate the CDSCO licensing process for the Filiform urethral bougie and achieve market access efficiently.