CDSCO License for Flexible video mammary ductoscope

Comprehensive Guide to CDSCO Licensing for Flexible Video Mammary Ductoscope (Class B)

The Flexible Video Mammary Ductoscope is a specialized obstetrical and gynecological medical device designed for the visual examination and treatment of the mammary duct. Given its critical role in early diagnosis and therapeutic intervention, regulatory compliance is paramount to ensure patient safety and market access in India.

With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide detailed, practical guidance to help you navigate the regulatory landscape efficiently.

CDSCO Regulatory Framework for Flexible Video Mammary Ductoscope

This device falls under the Class B risk category according to the Central Drugs Standard Control Organisation (CDSCO) classification, meaning it is considered a low to moderate risk device. The regulatory pathway for such a device is distinct and primarily governed by the State Licensing Authority through the MD5 license process.

The notification governing this device is referenced under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, which officially categorizes this device and mandates compliance with relevant standards.

Risk Classification and License Requirements

• Device Name: Flexible Video Mammary Ductoscope
• Risk Class: B (Low to Moderate Risk)
• Intended Use: Visual examination and treatment of mammary duct
• Category: Obstetrical and Gynecological

For Class B devices, the CDSCO mandates obtaining an MD5 Manufacturing License (Form MD3) before the device can be manufactured or marketed in India.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process is regulated by the respective State Licensing Authority and involves several stages:

1. Test License on Form MD13: Initially, manufacturers must apply for a test license to conduct product testing. This typically takes 1.5 to 2 months.

2. Product Testing: Testing must be performed through government-approved laboratories to validate safety and efficacy. You can refer to the list of approved testing laboratories.

3. Document Preparation: Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), and other essential technical files.

4. Application Submission: Submit the MD5 license application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body, whose list can be found here.

6. Query Resolution: Address any queries raised by the regulatory authorities or notified body during the review.

7. License Grant: Upon satisfactory compliance, the State Licensing Authority grants the MD5 license (Form MD5).

The entire process from test license application to final license grant generally takes 3 to 4 months.

Manufacturing License Documents Required

For the Flexible Video Mammary Ductoscope (Class B), the following documents are mandatory:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design, manufacturing, and quality details. Our Device Master File guide provides a step-by-step approach.
• Plant Master File (PMF): Details about the manufacturing facility and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with CDSCO standards
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485 certified

Import License Process (MD15)

If you are an importer of the Flexible Video Mammary Ductoscope, the applicable license is the MD15 Import License issued by the Central Licensing Authority. The process is as follows:

1. Prepare documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and others.

2. Submit the MD15 application (Form MD14) via the CDSCO MD Online Portal.

3. Address any queries from CDSCO.

4. Upon clearance, CDSCO issues the MD15 license.

The import license process usually takes 5 to 6 months due to extensive document verification.

Import License Documents Required

• Valid Manufacturing License from the manufacturer’s country
• Free Sale Certificate or Certificate of Marketability
• ISO 13485:2016 Certification
• CE Certificate or equivalent approval
• Device Master File and Plant Master File
• Wholesale Drug License for importers
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

For import licenses (MD15), expect 5 to 6 months due to additional central authority processing.

Government Fees and Costs

For the Flexible Video Mammary Ductoscope (Class B), the fee structure is:

• MD5 License Application Fees: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

These fees apply per manufacturing site and product variant. Additional costs include testing fees charged by approved laboratories and fees payable to notified bodies for audits.

Budgeting for these expenses upfront ensures a smoother process.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs.

Solution: Engage early with approved testing laboratories and pre-book testing slots to avoid delays.

Challenge: Incomplete or inconsistent technical documentation.

Solution: Utilize comprehensive guides for DMF and PMF preparation, such as our Device Master File guide and Plant Master File guide.

Challenge: Audit non-conformities raised by notified bodies.

Solution: Conduct pre-audit internal assessments and ensure QMS compliance to ISO 13485 standards.

Challenge: Unclear query responses leading to prolonged approval.

Solution: Provide clear, evidence-backed responses with relevant documentation to expedite query resolution.

Expert Consultation and Support

Given the complexities of CDSCO licensing for specialized devices like the Flexible Video Mammary Ductoscope, expert guidance can significantly reduce approval time and risk of rejection.

Our consultancy offers:

• End-to-end application preparation and submission
• Pre-audit readiness checks
• Liaison with testing labs and notified bodies
• Tailored risk management and compliance strategies

Engaging with seasoned professionals ensures your device meets all regulatory mandates smoothly.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device is Class B and requires an MD5 license.

2. Initiate Test License (Form MD13): Submit this early via the CDSCO MD Online Portal. Prepare your technical files in parallel.

3. Schedule product testing: Coordinate with government-approved labs to validate your device.

4. Compile comprehensive documentation: Use established templates and guides for DMF, PMF, risk management, and QMS files.

5. Apply for MD5 license (Form MD3): Post-test license and successful testing, submit your manufacturing license application.

6. Prepare for audit: Select an appropriate notified body and conduct internal audits.

7. Respond promptly to queries: Maintain open communication channels with CDSCO and the notified body.

8. Receive your MD5 license (Form MD5): Begin manufacturing and marketing your Flexible Video Mammary Ductoscope in India.

For importers, initiate the MD15 license application with complete documentation well in advance.

By following these practical steps and leveraging expert support, your pathway to CDSCO licensing will be efficient and successful.

For more insights or personalized assistance, feel free to reach out. Our team is committed to helping you navigate the Indian medical device regulatory environment with confidence and compliance.