CDSCO License for Bare-metal urethral stent, short-term
Medical Device Information
Intended Use
A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Comprehensive Guide to CDSCO Licensing for Bare-metal Urethral Stents (Short-term)
As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 medical device companies, we understand the unique challenges manufacturers and importers face when entering the Indian market. This detailed guide focuses on obtaining the CDSCO license for your bare-metal urethral stent, short-term — a Class C urology device designed for temporary urethral patency.
Overview of Bare-metal Urethral Stent (Short-term) and Regulatory Significance
Bare-metal urethral stents are sterile, non-bioabsorbable tubular implants intended for short-term use (≤ 30 days) to maintain urethral patency and facilitate urine flow, especially in patients suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Given its invasive nature and direct contact with the urinary tract, regulatory oversight is critical to ensure patient safety and device efficacy.
The CDSCO regulates this device under the Class C risk category, indicating a moderate to high risk that necessitates thorough evaluation and compliance with stringent regulatory standards before market authorization.
CDSCO Regulatory Framework for Bare-metal Urethral Stents
The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India under the Medical Device Rules (MDR) 2017. For Class C devices like the bare-metal urethral stent, the licensing process is centralized and handled by the CDSCO headquarters.
Key regulatory requirements include:
- Obtaining a Manufacturing License (MD9) for domestic manufacturing
- Acquiring an Import License (MD15) for imported devices
- Ensuring compliance with quality management systems such as ISO 13485:2016
- Adhering to essential principles, risk management, and device master file documentation
Risk Classification and License Requirements for Class C Devices
According to the Medical Device Classification, Class C devices pose moderate to high risk and require:
- A Manufacturing License (MD9) granted by the Central Licensing Authority
- Compliance with test license requirements (Form MD13) before full manufacturing license application
- Product testing in CDSCO-approved laboratories
- An audit by CDSCO inspectors
For importers, an Import License (MD15) is mandatory, which involves a separate application process but no test license prerequisite.
Manufacturing License Process (MD9) for Bare-metal Urethral Stent
The MD9 license process for Class C devices is comprehensive, ensuring your manufacturing site, processes, and products meet Indian regulatory standards:
- Apply for Test License (Form MD13): The first step enabling product testing. This typically takes 1.5 to 2 months.
- Product Testing: Submit the stent samples to one of the CDSCO-approved testing laboratories. Testing duration varies but usually aligns with the test license validity.
- Documentation Preparation: Prepare detailed technical files, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
- Apply for Manufacturing License (Form MD7): Submit the MD9 application via the CDSCO MD Online Portal. Ensure all documents and test reports are up-to-date.
- CDSCO Inspection and Audit: CDSCO officials conduct a thorough audit of your manufacturing facility.
- Query Resolution: Address any observations or queries raised during audit or application review.
- License Grant: On successful compliance, the MD9 license is issued.
The entire process from test license application to MD9 grant typically takes 4 to 5 months.
Manufacturing License Documents Required for MD9
Preparing a robust dossier is vital for successful licensing. Key documents for the bare-metal urethral stent include:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed design and manufacturing information (Device Master File Guide)
- Plant Master File (PMF): Facility layout, equipment, and process descriptions (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification preferred)
Import License Process (MD15) for Bare-metal Urethral Stent
For importers of bare-metal urethral stents, the MD15 license application process is centralized and slightly different:
- Document Preparation: Compile all necessary documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, and CE Certificates.
- Apply for MD15 License (Form MD14): Submit via the CDSCO MD Online Portal.
- Review and Query Resolution: Address any CDSCO queries promptly.
- License Grant: Final approval and issuance of the import license.
No test license is required for import licensing. The process generally takes about 5 to 6 months.
Import License Documents Required for MD15
Key documents required for import licensing include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent regulatory approval
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| MD13 Test License | 1.5 – 2 months |
| Product Testing | Concurrent with test license validity |
| MD9 Manufacturing License | 4 – 5 months (including audit) |
| MD15 Import License | 5 – 6 months |
Government Fees and Costs
For the bare-metal urethral stent, a Class C device, the fee structure is as follows:
- MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
- MD13 Test License: Usually included in the manufacturing license fees
- MD15 Import License: USD 3,000 per site + USD 1,500 per product
Additional costs may include testing fees charged by approved laboratories and consultancy fees if outsourcing regulatory support.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited testing slots at approved labs.
Solution: Schedule sample submission well in advance and maintain constant communication with testing labs listed on the CDSCO Testing Laboratories page.
Challenge: Incomplete or inconsistent documentation leading to multiple rounds of queries.
Solution: Utilize checklists and expert review to ensure all documents — especially DMF, PMF, and Risk Management Files — are complete and compliant.
Challenge: Audit non-compliance due to facility or process gaps.
Solution: Conduct internal pre-audits and engage with notified bodies or consultants to prepare for CDSCO inspections. Refer to the list of notified bodies for audit requirements.
Expert Consultation and Support
Navigating the CDSCO licensing landscape for Class C devices like the bare-metal urethral stent requires detailed technical knowledge and strategic planning. Our team has successfully guided over 500 companies through this process, providing:
- Comprehensive gap assessments
- Document preparation and review
- Liaison with CDSCO and notified bodies
- Audit readiness and training
Our expertise ensures minimized delays and maximized compliance, enabling you to bring your urology device to the Indian market efficiently.
Getting Started with Your CDSCO License Application
To embark on your CDSCO licensing journey for the bare-metal urethral stent:
- Evaluate Your Device Classification: Confirm Class C status and regulatory requirements.
- Prepare Your Technical Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (MD13): Initiate the testing phase promptly to avoid delays.
- Engage with Approved Testing Labs: Submit samples early and track progress.
- Develop a Compliance Timeline: Plan for document submission, audits, and potential query resolution.
- Submit Manufacturing License Application (MD9) via the CDSCO MD Online Portal: Ensure complete and accurate application.
- Prepare for Audit: Conduct internal reviews to address any potential gaps.
By following these steps and leveraging expert support, manufacturers and importers can successfully navigate the CDSCO licensing process for bare-metal urethral stents and ensure timely access to the Indian healthcare market.
