CDSCO License for Bartholin Gland Catheter

Comprehensive Guide to CDSCO Licensing for Bartholin Gland Catheter (Class B Medical Device)

The Bartholin Gland Catheter is a specialized medical device designed for the treatment of abscesses and cysts of the Bartholin gland. As a Class B device under Indian regulations, it requires a meticulous regulatory approval process through the Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide you with clear, actionable insights to streamline your market entry in India.

Understanding the CDSCO Regulatory Framework for Bartholin Gland Catheters

In India, medical devices are regulated under the Medical Device Rules (MDR), 2017, overseen by CDSCO. The Bartholin Gland Catheter falls under the category of catheters and is classified as a Class B device, which indicates low to moderate risk.

The key regulatory notification governing this device is Notification 29/Misc/3/2017-DC (292), issued on 06.06.2018. Compliance with this regulatory framework ensures product safety, efficacy, and quality for Indian patients.

Risk Classification and License Requirements for Class B Devices

Medical devices in India are categorized into Class A, B, C, and D based on potential risk. Class B devices like the Bartholin Gland Catheter require a manufacturing license known as the MD5 License. This license is issued by the State Licensing Authority and involves a thorough process including product testing, documentation, and an audit by a notified body.

For more detailed insights on device classification, visit our Medical Device Classification resource.

Manufacturing License Process (MD5) for Bartholin Gland Catheter

Obtaining an MD5 license involves several sequential steps:

1. Test License Application (Form MD13): Begin by applying for a test license, which permits manufacturing of the device for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: After obtaining the test license, product samples must be tested at government-approved laboratories to verify compliance with relevant standards. Refer to the list of approved testing laboratories for suitable facilities.

3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) protocols, and risk management files.

4. License Application Submission (Form MD3): Submit the manufacturing license application along with supporting documents through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility. Check the list of notified bodies authorized for MD5 audits.

6. Queries Resolution: Address any queries raised by the CDSCO or notified body promptly to avoid delays.

7. Grant of License (Form MD5): Upon successful audit and document verification, the MD5 license is granted.

Manufacturing License Documents Required for Class B Devices

For the Bartholin Gland Catheter, you must prepare and submit the following:

• Company Constitution Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, components, and specifications. Our Device Master File Guide can assist you.
• Plant Master File (PMF) describing manufacturing processes and facility layout. Refer to our Plant Master File Guide.
• Essential Principles Checklist ensuring compliance with safety and performance requirements
• Risk Management File highlighting identified risks and mitigation strategies. Learn more about risk management implementation.
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation compliant with ISO 13485:2016

Import License Process (MD15) for Bartholin Gland Catheter

If you plan to import the Bartholin Gland Catheter into India, you must obtain an MD15 import license from the Central Licensing Authority. The process includes:

1. Document Compilation: Gather all required documents such as Manufacturing License, Free Sale Certificate, ISO certification, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.

2. Application Submission (Form MD14): File your application on the CDSCO MD Online Portal.

3. Queries Resolution: Respond to any clarifications requested by the CDSCO.

4. Grant of Import License (Form MD15)

The import license process is more centralized and typically takes 5-6 months. Unlike manufacturing licenses, no test license is required.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for import
• Company Constitution

Timeline and Processing Duration

For import license (MD15), the total time ranges from 5 to 6 months.

Government Fees and Costs

• MD5 Manufacturing License: Application fee Rs 5,000 + Rs 500 per product
• MD15 Import License: Fees vary by device class; for Class B devices, expect approx Rs 2,000 per site + Rs 1,000 per product

Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.

Common Challenges and Solutions in Licensing Bartholin Gland Catheters

• Delayed Testing Reports: Ensure timely coordination with approved labs to avoid bottlenecks.
• Incomplete Documentation: Use checklists and consult experienced regulatory experts to avoid rejected submissions.
• Audit Non-Compliance: Conduct internal pre-audits and train your staff to meet audit expectations.
• Query Resolution Delays: Respond promptly with clear, evidence-backed documents.

Expert Consultation and Support

Given the complex regulatory landscape, partnering with a seasoned consultant can significantly reduce time, cost, and risk. Our team has successfully guided over 500 manufacturers and importers through CDSCO processes, ensuring accelerated approvals and compliance.

Getting Started with Your CDSCO License Application for Bartholin Gland Catheter

1. Assess Classification: Confirm your device classification as Class B.
2. Initiate Test License Application: Apply for the MD13 test license via the CDSCO MD Online Portal.
3. Plan Product Testing: Identify and engage with government-approved testing laboratories.
4. Prepare Documentation: Develop detailed DMF, PMF, Risk Management, and QMS documents.
5. Schedule Audit: Coordinate with notified bodies early to book audit dates.
6. Submit Licensing Application: File your MD5 application (Form MD3) online.
7. Monitor and Respond: Stay proactive in addressing CDSCO or notified body queries.

Embarking on the licensing journey with a clear roadmap and expert support will facilitate a smooth entry of your Bartholin Gland Catheter into the Indian market. For personalized assistance, feel free to reach out to our regulatory consulting team.