CDSCO License for Rigid urethroscope
Medical Device Information
Intended Use
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine).
Comprehensive Guide to CDSCO Licensing for Rigid Urethroscope (Class B Medical Device)
With over 25 years of expertise and having assisted more than 500 companies in navigating the complex Indian regulatory landscape, we present an authoritative, step-by-step guide to obtaining your CDSCO license for manufacturing or importing the Rigid Urethroscope — a Class B medical device under the urology category.
Introduction to Rigid Urethroscope and Regulatory Importance
A rigid urethroscope is a critical endoscopic instrument used for the visual examination and treatment of the urethra. Given its direct contact with the urinary tract, ensuring safety, efficacy, and compliance with Indian regulations is paramount. The Central Drugs Standard Control Organization (CDSCO) governs device approvals, ensuring only safe and quality products reach patients. Compliance with CDSCO not only affirms market access but also builds trust with healthcare providers.
CDSCO Regulatory Framework for Rigid Urethroscope
Rigid urethroscopes fall under Class B risk classification, which means they have a moderate risk profile requiring a stringent yet streamlined regulatory approval process. As per the Government of India’s notification (File No. 29/Misc./03/2020-DC (145), dated 23.8.2021), these devices are categorized under urology.
The regulatory framework mandates the following:
- Manufacturing license via Form MD3 (MD5 License) granted by the State Licensing Authority.
- If importing, an Import License (MD15) issued by the Central Licensing Authority.
For manufacturing, a test license (MD13) is prerequisite, along with product testing from CDSCO-approved labs.
Risk Classification and License Requirements
| Risk Class | Device Type | License Type | Licensing Authority | Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Class B | Rigid Urethroscope | MD5 | State Authority | 3-4 months | ₹5,000 (application) + ₹500/product |
For detailed classification, you can refer to our Medical Device Classification guide.
Manufacturing License Process (MD5 License for Class B Devices)
Obtain Test License (Form MD13): Apply for a test license allowing you to manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.
Product Testing: Submit your rigid urethroscope samples to CDSCO-recognized testing laboratories. Testing ensures compliance with essential safety and performance standards. Refer to the CDSCO Testing Laboratories list.
Documentation Preparation: Prepare comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and QMS documents.
Application Submission: File your manufacturing license application using Form MD3 on the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit of your manufacturing facility is conducted by a CDSCO notified body. You can check the list of notified bodies.
Query Resolution: Respond promptly to any queries or deficiencies noted by the authority or notified body.
Grant of License: Upon satisfactory review and audit, you will receive the manufacturing license (Form MD5).
Manufacturing License Documents Required
- Company Constitution (e.g., Memorandum and Articles of Association)
- Proof of ownership/lease of manufacturing premises
- Technical staff qualification documents
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing process documentation. Our Device Master File guide offers practical tips.
- Plant Master File (PMF): Details of manufacturing facilities and quality control systems. Learn more in our Plant Master File guide.
- Essential Principles Compliance Checklist
- Risk Management File compliant with ISO 14971. See our Risk Management resource.
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process (MD15 License)
If you plan to import the rigid urethroscope into India, the process is managed by the Central Licensing Authority:
Document Preparation: Assemble all requisite documents including manufacturing license from the country of origin, free sale certificate, ISO 13485 certification, CE certificate, DMF, PMF, wholesale license, and company constitution.
Application Filing: Submit application on Form MD14 via the CDSCO MD Online Portal.
Query Resolution: Address any queries promptly.
License Grant: Receive your import license (Form MD15).
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Document Preparation | 2 - 3 weeks |
| Application Review & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total Time for MD5 License | ~3 to 4 months |
For import licenses (MD15), the entire process usually spans 5 to 6 months.
Government Fees and Costs
- MD5 License: ₹5,000 per application plus ₹500 per product
- MD13 Test License: Included in MD5 process fees
- MD15 Import License: Fee structure varies by class; for Class B, approximately ₹2,000 per site plus ₹1,000 per product
Note: These fees are payable online via the CDSCO portal during application submission.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or incomplete DMF or PMF. We recommend early preparation following our detailed guides.
Testing Delays: Samples often get rejected due to improper packaging or incomplete information. Always use CDSCO-approved labs and follow their submission protocols.
Audit Non-compliance: Facilities sometimes fail audits due to inadequate QMS or poor housekeeping. Pre-audit internal checks and mock audits can mitigate risks.
Query Management: Timely and clear responses to CDSCO’s queries significantly reduce processing time. Maintain a dedicated regulatory liaison.
Expert Consultation and Support
Our team has successfully guided 500+ medical device manufacturers and importers through the CDSCO licensing process for devices like the rigid urethroscope. We offer:
- Customized gap analysis and documentation assistance
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- End-to-end application filing and query management
Engaging expert consultants can reduce your approval timeline and increase the likelihood of first-time approval.
Getting Started with Your CDSCO License Application for Rigid Urethroscope
Assess your Device Classification: Confirm the device is Class B as per the official CDSCO classification.
Initiate Test License Application: Apply for your MD13 test license on the CDSCO MD Online Portal.
Prepare Comprehensive Documentation: Start compiling your DMF, PMF, risk management files, and all supporting documents.
Identify Testing Laboratories: Coordinate with CDSCO-approved labs early. Refer to the Testing Laboratories list.
Schedule Notified Body Audit: Select an appropriate notified body for your audit via the Notified Bodies List and prepare for inspection.
Submit Manufacturing License Application: Once testing and audit are complete, file your MD5 license application.
Plan for Query Resolution: Allocate resources for prompt responses to CDSCO or notified body queries.
Embarking on your CDSCO licensing journey with a clear roadmap and expert support maximizes your chances of timely market entry. Contact us to leverage our extensive experience and facilitate a smooth approval process for your rigid urethroscope in India.
