CDSCO License for Intermittent urethral catheterization kit, non- sterile

Comprehensive Guide to CDSCO Licensing for Intermittent Urethral Catheterization Kit (Non-Sterile, Class B)

As seasoned regulatory consultants with over 25 years of experience and having guided 500+ medical device companies through the Indian regulatory landscape, we understand the unique challenges manufacturers face in obtaining CDSCO licenses. This guide focuses on the Intermittent Urethral Catheterization Kit, a Class B urology device, and provides step-by-step insights to help you successfully navigate the licensing process.

Understanding the Device and Regulatory Importance

The Intermittent Urethral Catheterization Kit (non-sterile) is a collection of non-sterile items including a urological catheter, cap, and accessories designed for self-urinary catheterization. Classified as Class B by CDSCO, this device falls into a moderate risk category requiring a structured regulatory approach. Compliance ensures patient safety, market access, and legal operations in India.

CDSCO Regulatory Framework for Intermittent Urethral Catheterization Kits

Medical devices in India are regulated under the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). Class B devices like this catheterization kit require a manufacturing license (MD5) from the State Licensing Authority.

Manufacturers must comply with quality standards, submit detailed documentation, and undergo product testing and audits to demonstrate compliance with the Essential Principles of Safety and Performance.

Risk Classification and License Requirements

Your device is classified as Class B, which means it demands a MD5 manufacturing license. This process is managed by the State Licensing Authority and typically takes 3-4 months, including pre-license testing and audits.

Manufacturing License Process (MD5)

The MD5 license process for Class B devices involves several key steps:

1. Obtaining a Test License (Form MD13): Before manufacturing, you must apply for and obtain a Test License which permits product testing at approved labs. This generally takes 1.5 to 2 months.

2. Product Testing: Samples must be tested at government-approved laboratories to verify compliance with standards.

3. Document Preparation: Prepare all necessary technical and quality documentation.

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

5. Audit by Notified Body: An audit is conducted by a notified body to verify compliance with MDR and QMS.

6. Query Resolution: Address any queries from the licensing authority or the notified body.

7. Grant of License (Form MD5): Once all requirements are met, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required

For your non-sterile intermittent urethral catheterization kit, prepare the following key documents:

• Company constitution and registration proof
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire safety and pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File guide)
• Plant Master File describing facility layout and equipment (Plant Master File guide)
• Essential Principles Checklist confirming compliance with MDR
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test reports from approved labs
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485 compliant preferred)

Import License Process (MD15)

If you plan to import this device into India, an MD15 license is required from the Central Licensing Authority. The MD15 process takes approximately 5-6 months and requires submission of documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate, Device and Plant Master Files, and wholesale license.

More details on import licensing can be found in our Import License guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• Application fee for MD5 license: ₹5,000
• Fee per product: ₹500
• Testing and audit costs vary depending on the notified body and laboratory fees (typically ₹50,000 - ₹1,00,000)

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit complete and error-free applications; engage with notified bodies early.

Challenge 2: Incomplete or Non-compliant Documentation

• Solution: Use checklists to ensure all documents meet CDSCO requirements; our Device Master File guide can help.

Challenge 3: Audit Non-conformities

• Solution: Prepare your quality system in advance, conduct internal audits, and train staff thoroughly.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with detailed evidence; maintain open communication with authorities.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our expert regulatory team has successfully assisted over 500 companies in securing licenses for devices like the Intermittent Urethral Catheterization Kit. We provide end-to-end support from document preparation, liaising with notified bodies, to audit readiness.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s Class B status as per the Medical Device Classification.

2. Gather Core Documents: Begin compiling your Company Constitution, technical staff details, and premises ownership proofs.

3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.

4. Plan Product Testing: Coordinate with approved laboratories early to schedule testing.

5. Prepare Technical Files: Develop your Device Master File and Plant Master File following best practices.

6. Engage a Notified Body: Identify and appoint a notified body from the official Notified Bodies List for the mandatory audit.

7. Submit MD5 Application: Once testing and documentation are complete, file Form MD3 on the CDSCO portal.

8. Prepare for Audit: Train your team and conduct mock audits to ensure compliance.

Embarking on this structured path with expert guidance maximizes your chances for a smooth and timely license grant, paving the way for your Intermittent Urethral Catheterization Kit’s successful launch in the Indian market.