CDSCO License for Urethral/suprapubic catheter valve-connector

Comprehensive Guide to CDSCO Licensing for Urethral/Suprapubic Catheter Valve-Connector (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we understand the intricacies involved in navigating India’s medical device regulatory landscape. This guide focuses specifically on the urethral/suprapubic catheter valve-connector, a Class A device used in urology for intermittent bladder drainage/filling.

Understanding the Urethral/Suprapubic Catheter Valve-Connector and Regulatory Importance

The urethral/suprapubic catheter valve-connector is a small, sterile valve designed to be connected to urethral or suprapubic catheters. It enables intermittent bladder drainage as an alternative to continuous drainage, improving patient comfort and reducing infection risks. Due to its critical role in patient care and its classification as a Class A medical device, obtaining the correct CDSCO license is mandatory before manufacturing or importing this product into India.

The device falls under the notification File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, which classifies it explicitly as a Class A device under the urology category.

CDSCO Regulatory Framework for Urethral/Suprapubic Catheter Valve-Connector

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. For Class A devices like this valve-connector, the licensing authority is the State Licensing Authority.

Manufacturers require an MD5 license (Form MD3 application), whereas importers must apply for an MD15 import license (Form MD14 application). Given the device’s risk class and intended use, the MD5 manufacturing license pathway is straightforward but requires thorough documentation and adherence to quality standards.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3

Being a Class A device, the regulatory requirements are relatively less stringent compared to higher classes; however, compliance with quality management systems and testing requirements remains critical.

Manufacturing License Process for MD5 (Class A Device)

The entire MD5 licensing process typically spans 3 to 4 months and includes the following steps:

1. Apply for Test License (Form MD13): Before full license application, obtain a test license allowing product testing; timeline 1.5 to 2 months.
2. Product Testing: Conduct testing of the catheter valve-connector at CDSCO-approved government testing laboratories.
3. Documentation Preparation: Prepare Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, labels, Instructions For Use (IFU), and Quality Management System (QMS) documents.
4. Submit MD5 License Application (Form MD3): File the application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a mandatory audit by a CDSCO-notified body. You can check the list of notified bodies for audit agencies.
6. Department Queries and Response: Address any queries raised by the licensing authority or notified body.
7. Grant of License: Upon successful audit and document verification, the MD5 license is granted.

Manufacturing License Documents Required for MD5

Accurate and comprehensive documentation is essential. The following documents must be submitted:

• Company Constitution (Incorporation Certificate, Memorandum of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design, manufacturing process, and specifications. Our Device Master File guide offers practical tips.
• Plant Master File (PMF): Details of manufacturing facilities and equipment. See our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian MDR
• Risk Management File aligning with ISO 14971 principles; refer to our Risk Management guide.
• Test Reports from government-approved labs (review the Testing Laboratories list)
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process for Urethral/Suprapubic Catheter Valve-Connector (MD15)

For importers, the CDSCO mandates an MD15 import license. This process, managed by the Central Licensing Authority, generally takes 5 to 6 months.

Key steps include:

• Preparation of necessary documents (including existing manufacturing license from country of origin, CE Certificate, Free Sale Certificate, ISO 13485 certification, Device and Plant Master Files).
• Application submission on the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• Grant of the import license (Form MD15).

Import License Documents Required

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

Timeline and Processing Duration

Manufacturing license applicants should plan for a total of 3 to 4 months to cover all phases comprehensively.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Included within the overall process costs
• Audit Fees: Payable separately to notified bodies (varies; typically Rs. 50,000 to Rs. 1,00,000 depending on notified body and audit scope)

Budgeting for these fees upfront helps avoid delays.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants fail due to missing or inconsistent documents. We recommend a thorough pre-submission checklist.
• Delay in Product Testing: Engage with government-approved labs early and plan sample submission well in advance.
• Audit Nonconformities: Prepare your manufacturing site and QMS rigorously; conduct internal audits beforehand.
• Responding to Queries: Timely and clear responses avoid prolonged processing times.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our expert team, with 25+ years’ experience, offers end-to-end support—from test license application, document preparation, audit facilitation, to final license grant. We ensure compliance with the latest MDR guidelines and optimize processing timelines.

Getting Started with Your CDSCO License Application

1. Assess Risk Classification: Confirm your device’s classification (Class A for urethral/suprapubic catheter valve-connector).
2. Initiate Test License Application: Apply for test license (Form MD13) via the CDSCO MD Online Portal.
3. Plan Product Testing: Coordinate with an approved testing laboratory early.
4. Prepare Documentation: Utilize our Device and Plant Master File guides to compile robust documentation.
5. Engage a Notified Body: Select from the list of notified bodies for your audit.
6. Submit MD5 License Application: After completing testing and document readiness, submit your license application via the portal.

For detailed guidance or to initiate your license application, contact our regulatory consultancy team to leverage our proven strategies and ensure a smooth pathway to market access.

By following this comprehensive roadmap tailored to the urethral/suprapubic catheter valve-connector, manufacturers and importers can confidently meet CDSCO requirements and successfully enter the Indian medical device market.