CDSCO License for Intermittent urethral drainage catheter, sterile

Comprehensive Guide to CDSCO Licensing for Intermittent Urethral Drainage Catheters (Sterile, Class B)

At our consultancy, with over 25 years of experience and having assisted 500+ companies in securing CDSCO approvals, we understand the complexities of navigating India’s medical device regulatory landscape. This guide focuses on the intermittent urethral drainage catheter, a sterile Class B urology device, intended to provide episodic urine drainage for patients unable to void naturally. Whether you are a manufacturer or importer, obtaining the correct CDSCO license is critical to legally market this device in India.

Understanding the CDSCO Regulatory Framework for Intermittent Urethral Drainage Catheters

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Devices like the intermittent urethral drainage catheter fall under Class B – a moderate risk category. As a Class B device, you must obtain a manufacturing license (MD5) from the State Licensing Authority if manufacturing in India, or an import license (MD15) from CDSCO’s Central Licensing Authority if importing.

The device is covered under the urology category, notified as per File No. 29/Misc./03/2020-DC (145) dated 23.8.2021. This notification is crucial for classification and regulatory requirements.

Risk Classification and License Requirements for Class B Devices

Being a Class B device, the intermittent urethral drainage catheter requires compliance with moderate regulatory controls. The primary license types are:

• MD5 Manufacturing License: For domestic manufacturers. Application is submitted on Form MD3 through the CDSCO MD Online Portal.
• MD15 Import License: For importers. Application is submitted on Form MD14.

Class B devices require comprehensive documentation, product testing from government-approved labs, and an audit by a notified body before licensing.

Step-by-Step Manufacturing License Process (MD5) for Class B Catheters

1. Test License Application (Form MD13): Before applying for MD5, you must obtain a test license. This takes approximately 1.5 to 2 months. The test license allows you to send samples for mandatory product testing.

2. Product Testing: Samples must be tested at CDSCO-approved laboratories. You can find the list of Testing Laboratories here. Testing ensures compliance with Indian standards and safety.

3. Document Preparation: Prepare all required documents meticulously, including Device Master File, Plant Master File, risk management files, and proof of technical staff qualifications.

4. License Application (Form MD3): Submit your manufacturing license application on the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body. Refer to the list of notified bodies authorized for MD5 audits.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License: On successful completion, the MD5 license is issued on Form MD5.

Essential Documents Required for MD5 License Application

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications. Our Device Master File guide can help streamline this process.
• Plant Master File (PMF) describing manufacturing processes. See our Plant Master File guide.
• Essential Principles Checklist confirming compliance with MDR requirements
• Risk Management File demonstrating hazard identification and mitigation strategies. Learn more about medical device risk management.
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Intermittent Urethral Drainage Catheters

If you plan to import this device, the MD15 license from CDSCO is mandatory. The process is as follows:

1. Document Compilation: Gather all mandatory documents including a valid manufacturing license, free sale certificate from the country of origin, ISO 13485:2016, CE certificate (if applicable), Device and Plant Master Files, and wholesale license.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Address any departmental queries promptly.

4. License Issuance: Upon satisfaction, the import license MD15 is granted.

Documents Required for MD15 Import License

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total.

  • Test License (MD13): 1.5-2 months
  • Product Testing: 2-4 weeks
  • Audit & Query Resolution: 4-6 weeks

• MD15 Import License: Approximately 5-6 months.

Timelines may vary based on document completeness and responsiveness to queries.

Government Fees and Costs

• MD5 License Fees: Rs 5,000 per application plus Rs 500 per product.
• MD15 Import License Fees: For Class B devices, approximately $2,000 per site and$1,000 per product.

Additional costs include laboratory testing fees, notified body audit charges, and consultancy fees if applicable.

Common Challenges and Practical Solutions

• Delay in Test License Issuance: Early preparation of test samples and documents can shorten this phase.
• Incomplete Documentation: Utilize checklists and templates available through our guides to avoid rejections.
• Audit Non-Compliance: Conduct mock audits internally or with expert consultants to ensure readiness.
• Query Management: Assign dedicated personnel to monitor and respond promptly to regulator queries.

Expert Consultation and Support

Our comprehensive support includes device classification assistance, document preparation, liaison with notified bodies, and audit preparedness to ensure a smooth licensing journey. For instance, one of our clients manufacturing sterile intermittent catheters reduced their licensing time by 30% through our end-to-end service.

Getting Started with Your CDSCO License Application

1. Determine Your License Type: Confirm if you are manufacturing domestically (MD5) or importing (MD15).
2. Gather Preliminary Documents: Obtain company constitution, technical staff details, and premises ownership proof.
3. Engage Testing Laboratories Early: Identify and contact government-approved labs from the Testing Laboratories list to schedule product testing.
4. Prepare Master Files: Develop Device and Plant Master Files using our expert guides.
5. Register and Apply Online: Use the CDSCO MD Online Portal to submit your application forms.
6. Plan for Audit: Coordinate with a notified body early for audit scheduling.

By following these actionable steps, manufacturers and importers of sterile intermittent urethral drainage catheters can efficiently navigate the regulatory requirements and successfully bring their products to the Indian market.

For detailed guidance, feel free to reach out to our expert team who has helped over 500 companies achieve regulatory compliance with speed and confidence.