CDSCO License for Flexible fibreoptic mammary ductoscope

Introduction to Flexible Fibreoptic Mammary Ductoscope and Regulatory Importance

The Flexible Fibreoptic Mammary Ductoscope is a specialized medical device designed for the visual examination and treatment of the mammary duct, playing a vital role in obstetrical and gynecological diagnostics. Given its direct application in sensitive clinical procedures, regulatory compliance in India is essential to ensure patient safety and product efficacy. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing framework is critical for manufacturers and importers aiming to market this device in India.

With over 25 years of expertise and having assisted more than 500 companies, we understand the nuances of the CDSCO regulatory process for Class B devices like the Flexible Fibreoptic Mammary Ductoscope. This comprehensive guide details the applicable regulatory requirements, timelines, costs, and practical steps to secure your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Flexible Fibreoptic Mammary Ductoscope

The CDSCO classifies medical devices based on risk, intended use, and complexity. The Flexible Fibreoptic Mammary Ductoscope falls under Class B (low moderate risk) within the Obstetrical and Gynecological category, as per the notification File No. 29/Misc./03/2020-DC (181) dated 03.06.2022. This classification determines the applicable licensing route and compliance requirements.

For Class B devices manufactured domestically, the licensing authority is the State Licensing Authority via the MD5 license process. Importers must obtain an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements

Understanding the device's risk classification is crucial:

Class B devices require an MD5 Manufacturing License (Form MD3) when produced domestically.
The MD5 license process involves a test license (Form MD13), product testing at government-approved labs, audit by a notified body, and final license issuance.
For imports, an MD15 Import License (Form MD14) must be secured.

Refer to the Medical Device Classification guide for detailed categorization.

Manufacturing License Process for Flexible Fibreoptic Mammary Ductoscope (MD5)

Step 1: Obtain Test License (Form MD13)

Before the full manufacturing license application, you must apply for a test license allowing you to manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.

Step 2: Product Testing

Samples of your Flexible Fibreoptic Mammary Ductoscope must undergo testing at CDSCO-approved laboratories. You can find a list of Testing Laboratories on the CDSCO MD Online Portal.

Step 3: Documentation Preparation

Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

Step 4: Application Submission

Submit your application through the CDSCO MD Online Portal. The application form for MD5 is Form MD3.

Step 5: Audit by Notified Body

An audit is conducted by an accredited notified body. You can check the list of notified bodies to select an appropriate auditor.

Step 6: Query Resolution

Address any queries or deficiencies raised by the notified body or CDSCO during the evaluation.

Step 7: License Grant

Upon successful compliance, the State Licensing Authority grants the MD5 manufacturing license.

For a detailed procedural overview, refer to our MD5 License Guide.

Manufacturing License Documents Required

For the Flexible Fibreoptic Mammary Ductoscope manufacturing license, these documents are mandatory:

Company Constitution (e.g., Certificate of Incorporation)
Proof of ownership or valid lease of manufacturing premises
Qualification and experience documents of technical staff
Fire NOC and Pollution Control Board NOC
Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
Plant Master File describing manufacturing facilities (Plant Master File Guide)
Essential Principles Checklist ensuring compliance with safety and performance standards
Risk Management File documenting hazard analysis and mitigation (Risk Management)
Test Reports from CDSCO-approved laboratories
Labels and Instructions for Use (IFU)
Quality Management System documents, preferably ISO 13485:2016 certification

Import License Process for Flexible Fibreoptic Mammary Ductoscope (MD15)

For companies importing this device into India, the MD15 import license is mandatory. The process includes:

Comprehensive documentation preparation
Submission of application using Form MD14 on the CDSCO MD Online Portal
Query resolution as required by the Central Licensing Authority
Final grant of license on Form MD15

Unlike the manufacturing license, no test license or product testing at government labs is mandatory during import licensing.

For more details, explore our Import License Guide.

Import License Documents Required

Key documents for the MD15 license include:

Valid Manufacturing License from the country of origin
Free Sale Certificate or Certificate of Market Authorization
ISO 13485:2016 Quality Management System Certificate
CE Certificate or equivalent regulatory approval
Device Master File and Plant Master File
Wholesale License (if applicable)
Company Constitution documents

Timeline and Processing Duration

Manufacturing License (MD5) Timeline:

Test License (MD13): 1.5 to 2 months
Product Testing: 2 to 3 weeks
Audit and Inspection: 1 month
Query Resolution and Final Approval: 2 to 3 weeks

Total Duration: Approximately 3 to 4 months

Import License (MD15) Timeline:

Document Preparation and Submission: 1 month
Query Resolution and Final Approval: 4 to 5 months

Total Duration: Approximately 5 to 6 months

Government Fees and Costs

MD5 Manufacturing License Fees

Application Fee: Rs 5,000 per application
Product Fee: Rs 500 per product

MD15 Import License Fees (Central Authority)

Class B Device Fees: $2,000 per site and$ 1,000 per product

These fees are payable online via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

Incomplete Documentation: Many applicants fail to provide a complete Device Master File or Risk Management File. Solution: Utilize detailed templates and checklists to ensure completeness.
Delayed Product Testing: Testing labs may have backlogs leading to delays. Solution: Engage with labs early and plan sample submissions in advance.
Audit Non-Compliance: Audits may highlight gaps in manufacturing or QMS practices. Solution: Conduct internal audits before official audits and rectify deficiencies.
Query Resolution Delays: Slow responses to CDSCO queries can prolong timelines. Solution: Assign dedicated regulatory personnel for prompt communication.

Expert Consultation and Support

With over two decades of experience and a track record of enabling 500+ companies to successfully obtain CDSCO licenses, we provide end-to-end support—from documentation review to audit preparation. Our experts stay updated with regulatory amendments and can tailor your regulatory strategy for the Flexible Fibreoptic Mammary Ductoscope.

Getting Started with Your CDSCO License Application

Assess Your Product Classification: Confirm that your device is Class B and requires an MD5 license.
Prepare Documentation: Start with assembling your Device Master File, Plant Master File, and Risk Management documentation.
Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to begin manufacturing for testing.
Engage a Notified Body: Select an accredited auditor from the Notified Bodies List for your audit.
Plan Product Testing: Coordinate sample testing with CDSCO-approved laboratories.
Submit MD5 Application: After successful testing, apply for your manufacturing license using Form MD3.
Prepare for Audit: Conduct internal checks to ensure compliance ahead of the notified body audit.

Taking these practical steps with expert guidance can significantly streamline your path to obtaining the CDSCO license for your Flexible Fibreoptic Mammary Ductoscope, enabling you to confidently enter and compete in the Indian medical device market.