CDSCO License for Intermittent urethral catheterization kit, sterile

Comprehensive Guide to CDSCO Licensing for Intermittent Urethral Catheterization Kit (Sterile)

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the complexities involved in obtaining CDSCO licenses for medical devices in India. In this guide, we focus specifically on the Intermittent Urethral Catheterization Kit, sterile—a Class B urology device—as regulated under the CDSCO notification File No. 29/Misc./03/2020-DC (145) dated 23.8.2021.

Introduction: Understanding the Device and Regulatory Importance

An intermittent urethral catheterization kit is a sterile assembly consisting of a urological catheter (which may include a urine drainage bag), caps, and related accessories intended for self-urinary catheterization. Given its direct contact with the urinary tract, sterility and safety are paramount. Regulatory oversight ensures that such devices meet stringent quality, safety, and efficacy standards before entering the Indian market.

The Central Drugs Standard Control Organization (CDSCO) governs the licensing and regulation of these devices in India. Compliance with CDSCO not only facilitates market access but also ensures patient safety and legal conformity.

CDSCO Regulatory Framework for Intermittent Urethral Catheterization Kits

Intermittent urethral catheterization kits fall under the urology category and are classified as Class B devices based on the degree of risk they pose. Consequently, the licensing pathway involves obtaining an MD5 Manufacturing License, issued by the State Licensing Authority. For importers, an MD15 Import License from the Central Licensing Authority is mandatory.

Risk Classification and License Requirements

• Risk Class: B (Low-moderate risk)
• Applicable License: MD5 (Manufacturing License for Class A/B medical devices)
• Regulatory Authority: State Licensing Authority
• Supporting Licenses: Test License (MD13) is required prior to full license application

For detailed classification criteria, consult our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process is methodical and involves multiple steps:

1. Test License Application (Form MD13): This initial step grants permission to manufacture the device on a trial basis and typically takes 1.5 to 2 months.

2. Product Testing: The device must be tested in CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories.

3. Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and more must be compiled.

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

5. Audit by Notified Body: An audit is conducted by a CDSCO-recognized notified body; find the list of notified bodies here.

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

7. License Grant (Form MD5): Upon satisfactory review, the MD5 license is granted.

Manufacturing License Documents Required for Intermittent Urethral Catheterization Kit

The documentation package for MD5 licensing is extensive and includes:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed design and manufacturing information (Device Master File guide)
• Plant Master File (PMF): Overview of manufacturing facilities and quality control (Plant Master File guide)
• Essential Principles Checklist verifying compliance with Indian Medical Device Rules
• Risk Management File demonstrating implementation of risk controls (Risk Management overview)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for Intermittent Urethral Catheterization Kit

While this guide primarily addresses manufacturing in India, importers must obtain the MD15 license from the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO and CE certificates
• Applying via Form MD14 on the CDSCO MD Online Portal
• Query resolution
• License grant (Form MD15)

The import license process generally takes 5-6 months.

Import License Documents Required

• Valid Manufacturing License of the device in the exporting country
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution

Timeline and Processing Duration

For import licenses (MD15), expect approximately 5-6 months in total.

Government Fees and Costs

For MD5 Manufacturing License (Class B device):

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs include:

• Testing fees at approved laboratories (varies by test scope)
• Notified body audit fees (variable depending on body)
• Consultancy and documentation preparation (optional but recommended)

Common Challenges and Solutions

Challenge: Delays in product testing due to lab backlogs

Solution: Early engagement with CDSCO-approved testing labs and submission of samples well ahead of license application.

Challenge: Incomplete documentation causing audit non-conformities

Solution: Utilize detailed document checklists and consider expert consultancy to prepare Device Master File and Risk Management File.

Challenge: Responding to regulatory queries

Solution: Maintain a dedicated regulatory affairs team or partner with experienced consultants for timely and accurate responses.

Expert Consultation and Support

Navigating the CDSCO licensing process can be daunting, especially for first-time manufacturers or importers. Our vast experience and proven track record position us to offer:

• End-to-end application management
• Preparation of mandatory documentation including DMF, PMF, and Risk Management Files
• Coordination with notified bodies and testing laboratories
• Training and workshops on regulatory compliance

We encourage leveraging expert advice to minimize processing time and ensure compliance.

Getting Started with Your CDSCO License Application for Intermittent Urethral Catheterization Kit

1. Assess Classification: Confirm the device classification as Class B.
2. Initiate Test License Application: File Form MD13 on the CDSCO MD Online Portal to obtain permission for trial manufacturing.
3. Engage Testing Labs: Arrange for product testing at CDSCO-approved labs.
4. Prepare Documentation: Compile the Device Master File, Plant Master File, Risk Management File, and other required documents.
5. Schedule Audit: Contact a notified body from the official list of notified bodies to arrange the manufacturing site audit.
6. Submit MD5 License Application: Once test license and testing are complete, submit Form MD3 via the CDSCO portal.
7. Monitor Application Status: Address any queries promptly to avoid delays.
8. License Issuance: Upon successful completion, receive your MD5 manufacturing license.

Embarking on this path with meticulous preparation ensures your sterile intermittent urethral catheterization kits reach Indian patients safely and compliantly. For tailored assistance, feel free to connect with our regulatory experts.

For more detailed guides, visit our comprehensive MD5 License Guide or contact us to leverage our 25+ years of expertise in CDSCO licensing.