CDSCO License for Post Breast Biopsy Hemostatic Breast Compression Device

Introduction to Post Breast Biopsy Hemostatic Breast Compression Device and Regulatory Importance

The Post Breast Biopsy Hemostatic Breast Compression Device is a critical radiotherapy accessory designed to achieve and maintain hemostasis at breast biopsy wound sites. Given its direct clinical application in controlling bleeding post-procedure, this device plays a vital role in patient safety and treatment efficacy. Due to its intended use and associated risk, regulatory compliance is mandatory for manufacturers and importers aiming to market this device in India.

At our consultancy, with over 25 years of experience aiding 500+ companies, we understand the complexities and nuances involved in obtaining CDSCO licenses for devices like this. This guide will walk you through the entire regulatory framework, licensing pathways, timelines, costs, and practical tips specific to the Post Breast Biopsy Hemostatic Breast Compression Device, classified as a Class C medical device under CDSCO.

CDSCO Regulatory Framework for Post Breast Biopsy Hemostatic Breast Compression Device

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India. The device falls under the Class C category as per the Medical Device Classification, implying a moderate to high potential risk to patients and users.

Per the Notification File No. 29/Misc./03/2020-DC (180) dated 6th August 2021, this device requires adherence to stringent manufacturing and import licensing requirements under the CDSCO framework.

Risk Classification and License Requirements

As a Class C device, the Post Breast Biopsy Hemostatic Breast Compression Device requires:

• Manufacturing License: MD9 License granted by the Central Licensing Authority.
• Import License: MD15 License granted by the Central Licensing Authority.

These licenses ensure compliance with quality, safety, and efficacy standards mandated by CDSCO.

Manufacturing License Process (MD9)

The MD9 license process involves multiple stages, designed to verify manufacturing capability and product safety:

1. Test License (Form MD13): The first step is obtaining a Test License to manufacture the device for testing and validation purposes. This typically takes 1.5 to 2 months.

2. Product Testing: Testing must be conducted at CDSCO-approved laboratories to verify compliance with essential principles.

3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.

4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal with all required documents.

5. Audit by CDSCO Inspectors: The Central Licensing Authority will conduct an on-site audit to verify compliance.

6. Resolution of Queries: Address any queries raised by the CDSCO or auditors promptly.

7. License Grant (Form MD9): Upon satisfactory compliance, CDSCO grants the manufacturing license.

For a Class C device, the entire process takes approximately 4 to 5 months.

Manufacturing License Documents Required

Accurate and complete documentation is key to a successful MD9 license application. Required documents include:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Personnel
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facilities and controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
• Product Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, typically ISO 13485:2016 certification

Import License Process (MD15)

For importers seeking to bring the device into India, the MD15 import license process involves:

1. Document Preparation: Compile necessary certificates and licenses, including manufacturing license from the country of origin.

2. Application Submission: Apply through the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond to any departmental queries.

4. License Grant: Upon clearance, CDSCO issues the MD15 Import License.

Unlike manufacturing, import licensing does not require a test license or product testing in India but demands robust documentation.

Import License Documents Required

Key documents for MD15 application include:

• Valid Manufacturing License (MD9 or equivalent) from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Proactive engagement with the CDSCO and thorough document preparation can help avoid delays.

Government Fees and Costs

• Import license fees vary by device class:

• Class C & D: Rs. 2,25,000 per site + Rs. 1,12,500 per product (converted approx)

Manufacturers should budget for additional costs such as notified body audits and testing fees.

Common Challenges and Solutions

• Incomplete Documentation: Missing or poorly prepared Device Master Files and Risk Management Files can cause rejections. We recommend detailed document checklists and pre-submission audits.

• Testing Delays: Testing at government-approved labs may experience backlogs. Early sample submission and alternative approved labs can mitigate this.

• Audit Non-compliance: Non-alignment with QMS or facility standards leads to audit observations. Prior internal audits and third-party consultancy support reduce this risk.

• Query Resolution Delays: Slow responses to CDSCO queries stall approvals. Dedicated regulatory teams ensure timely follow-ups.

Expert Consultation and Support

With decades of experience, we assist clients at every step—from document preparation to audit readiness and query management. Our expertise in Class C device licensing ensures your application is robust and compliant.

We also provide tailored training on risk management and QMS implementation, critical for maintaining ongoing compliance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class C status via Medical Device Classification resource.

2. Prepare Documentation: Develop Device Master File and Plant Master File using our detailed guides.

3. Apply for Test License: Initiate the MD13 test license application on the CDSCO MD Online Portal.

4. Engage Testing Labs: Coordinate with approved labs early to schedule product testing.

5. Compile and Submit MD9 Application: After test license and testing, submit your manufacturing license application (Form MD7) online.

6. Audit Preparation: Prepare for CDSCO inspections by conducting mock audits.

7. Import License Application: For importers, collect all mandatory certificates and submit the MD15 application.

By following these steps with professional support, manufacturers and importers of the Post Breast Biopsy Hemostatic Breast Compression Device can successfully navigate the CDSCO licensing process and enter the Indian market with confidence.