CDSCO License for Retention Type Catheter

Introduction to Retention Type Catheter and Regulatory Importance

Retention Type Catheters are critical medical devices designed to be placed into the bladder and secured for extended use, ensuring patient comfort and preventing urinary retention complications. Given their invasive nature and direct contact with the urinary system, regulatory oversight is essential to ensure safety, quality, and efficacy. For manufacturers and importers targeting the Indian market, obtaining the correct CDSCO license is a pivotal step. With over 25 years of experience assisting 500+ companies, we understand the nuances and challenges involved in navigating the regulatory landscape for Class B medical devices like Retention Type Catheters.

CDSCO Regulatory Framework for Retention Type Catheter

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules 2017 (MDR 2017). Retention Type Catheters fall under the category of "Catheters" and are classified as Class B devices based on their risk profile. The regulatory framework requires companies to secure a manufacturing license (MD5) for domestic production or an import license (MD15) for imported products. The regulatory controls ensure compliance with essential principles, quality management systems, and performance standards.

Risk Classification and License Requirements for Class B Devices

Retention Type Catheters are classified as Class B devices, representing low to moderate risk. As per the MDR 2017 and the notification 29/Misc/3/2017-DC (292) dated 06.06.2018, manufacturers must obtain an MD5 manufacturing license. This license is granted by the State Licensing Authority. For importers, an MD15 import license issued by the Central Licensing Authority is mandatory.

Key License Forms:

• Manufacturing License: MD5 (Application Form MD3)
• Test License (prior to MD5): Form MD13
• Import License: MD15 (Application Form MD14)

Manufacturing License Process for Retention Type Catheter (MD5 License)

For manufacturers producing Retention Type Catheters domestically, the MD5 license process involves several critical steps:

1. Test License Application (MD13 Form): Initially, apply for a test license valid for 6 months to conduct product testing and validation.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories. Access the list of testing laboratories for accredited facilities.
3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Submit Form MD3 for the MD5 license via the CDSCO MD Online Portal with the requisite fees.
5. Audit by Notified Body: Undergo an audit by a CDSCO notified body. Refer to the list of notified bodies for authorized auditors.
6. Queries Resolution: Address any queries raised during document review or audit.
7. License Grant: Upon satisfactory compliance, the MD5 license is granted on Form MD5.

Practical Insight:

Manufacturers often underestimate the time required for the notified body audit and product testing phases. Scheduling early and maintaining open communication with the auditor can reduce delays.

Manufacturing License Documents Required for Retention Type Catheter

To ensure a smooth application process, prepare the following key documents:

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership or valid tenancy of manufacturing premises
• Technical staff qualifications and experience
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File detailing product specifications and design (Device Master File Guide)
• Plant Master File describing manufacturing processes and quality controls (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance standards
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process for Retention Type Catheter (MD15 License)

Importers of Retention Type Catheters must apply for an MD15 license, governed by the Central Licensing Authority. The process includes:

1. Document Preparation: Gather all required documents such as a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
2. Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.
3. Review and Queries: The authority reviews the application and may raise queries.
4. License Issuance: Upon satisfactory compliance, the import license (MD15) is granted.

Note:

Unlike the manufacturing license, an MD15 license does not require a test license (MD13).

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution
• Relevant Product Labels and IFU

Timeline and Processing Duration

*Note: MD9 license is not applicable for Class B devices like Retention Type Catheters.

Government Fees and Costs for Retention Type Catheter Licensing

MD5 License Fees:

• Application fee: INR 5,000
• Per product fee: INR 500

MD15 Import License Fees:

• Class B devices: USD 2,000 per site + USD 1,000 per product

Budgeting for these fees upfront helps prevent application delays. Additionally, costs for product testing, notified body audits, and consultancy services should be factored into your project plan.

Common Challenges and Solutions in CDSCO Licensing

Challenge: Delays in product testing and audit scheduling.

Solution: Engage with notified bodies early, pre-book testing slots, and maintain compliance documentation meticulously.

Challenge: Incomplete or inconsistent documentation leading to query cycles.

Solution: Follow comprehensive checklists and leverage expert consultation to prepare and review documents thoroughly.

Challenge: Confusion about applicable standards and classification.

Solution: Refer to updated Medical Device Classification guides and regulatory notifications.

Expert Consultation and Support

With over 25 years in regulatory consulting and a track record of assisting 500+ medical device companies, we provide end-to-end support for Retention Type Catheter licensing. Our services include:

• Gap analysis and compliance assessment
• Preparation of Device and Plant Master Files
• QMS implementation support
• Coordination with notified bodies and testing labs
• Application drafting and submission via the CDSCO MD Online Portal
• Post-submission query management

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm that your Retention Type Catheter is Class B.
2. Prepare Essential Documents: Start compiling your Device Master File and Plant Master File using our expert guides and (Plant Master File Guide).
3. Apply for Test License (MD13): For manufacturing, initiate the test license application through the CDSCO portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early to avoid bottlenecks.
5. Plan for Audit: Select a notified body from the official list and schedule your audit.
6. Submit MD5 Application: Once testing and audit are complete, submit your manufacturing license application.

For importers, begin by gathering all import license documents and proceed to submit Form MD14.

Embarking on this journey with expert guidance ensures compliance, expedites approvals, and accelerates your market entry. Connect with us to leverage our deep expertise and make your Retention Type Catheter licensing hassle-free.