CDSCO License for Mammary Biopsy Needle

Comprehensive Guide to CDSCO Licensing for Mammary Biopsy Needle (Class B Medical Device)

The Mammary Biopsy Needle is a critical medical device used to extract tissue samples from breast tissue either by suction or surgical excision. Classified under Disposable Hypodermic Needles and designated as a Class B medical device, it demands a robust regulatory approach to ensure safety, efficacy, and market access in India. With over 25 years of experience and having assisted more than 500 companies, we provide an expert walkthrough of the CDSCO licensing process tailored specifically for this device.

CDSCO Regulatory Framework for Mammary Biopsy Needle

Under the Medical Devices Rules, 2017, enforced by the Central Drugs Standard Control Organization (CDSCO), medical devices are regulated based on risk classification. The Mammary Biopsy Needle falls under Class B – a low-to-moderate risk category. Compliance with CDSCO ensures your device meets Indian regulatory standards including safety, quality, and performance.

The relevant notification for this device is 29/Misc/3/2017-DC (292) dated 06.06.2018, which formally classifies disposable hypodermic needles including Mammary Biopsy Needles under Class B.

Risk Classification and License Requirements for Class B Devices

Class B devices require a Manufacturing License under Form MD5, issued by the State Licensing Authority. The license process involves multiple steps including obtaining a Test License (MD13), product testing at CDSCO-approved labs, document submission, and audit by a notified body.

Key points:

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Regulatory Authority: State Licensing Authority
• Timeline: Approximately 3-4 months (including testing and audit)
• Fees: Rs 5000 per application + Rs 500 per product

Manufacturing License Process for Mammary Biopsy Needle (MD5 License)

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, you must secure a Test License (MD13). This allows testing of your Mammary Biopsy Needle samples at CDSCO-recognized laboratories. The Test License process generally takes 1.5 to 2 months.

Step 2: Product Testing

Samples of the Mammary Biopsy Needle must be tested at government-approved labs to verify compliance with applicable standards such as ISO 7864 for needles. You can find the list of authorized labs on the CDSCO Testing Laboratories page.

Step 3: Document Preparation

Prepare comprehensive documentation including technical, quality, and safety files. This includes:

• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File
• Test Reports
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents

For detailed guidance, refer to our Device Master File guide and Plant Master File guide.

Step 4: Application Submission (Form MD3)

Submit your manufacturing license application using Form MD3 on the CDSCO MD Online Portal. Ensure all fields are correctly filled and documents uploaded.

Step 5: Audit by Notified Body

A notified body will conduct an audit of your manufacturing facility and QMS to verify compliance. You can check the list of notified bodies for audit assignments.

Step 6: Resolution of Queries

Be prepared to respond promptly to any queries raised by the CDSCO or notified body to avoid delays.

Step 7: Grant of Manufacturing License (Form MD5)

Once all requirements are met, the State Licensing Authority will issue the MD5 manufacturing license, allowing legal manufacture of the Mammary Biopsy Needle in India.

Manufacturing License Documents Required

For the Mammary Biopsy Needle manufacturing license, you will need the following key documents:

• Company constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Appointment letters and qualifications of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) with device specifications and design details
• Plant Master File (PMF) describing manufacturing processes
• Essential Principles Checklist aligned with Indian regulations
• Risk Management File reflecting ISO 14971 implementation
• Test reports from CDSCO approved labs
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485 certification recommended)

Import License Process for Mammary Biopsy Needle (MD15 License)

If you plan to import Mammary Biopsy Needles into India, an MD15 Import License from the Central Licensing Authority is mandatory. The process differs from manufacturing licensing:

• No test license required
• Submit application via Form MD14 on the CDSCO MD Online Portal
• Prepare documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and company incorporation documents

The import license typically takes 5-6 months to process.

More details on import licensing can be found in our Import License guide.

Timeline and Processing Duration Summary

Government Fees and Costs Breakdown

Keep in mind that notified body audit fees are separate and depend on the scope and duration of the audit. Factoring these costs upfront helps avoid surprises.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License and Product Testing

Solution: Initiate Test License application early and select accredited labs with shorter turnaround times. Maintain open communication with labs for sample tracking.

Challenge 2: Incomplete Documentation

Solution: Use detailed checklists and templates for Device and Plant Master Files. Engage experienced regulatory consultants to review documents prior to submission.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal pre-audits and gap assessments. Ensure your QMS and manufacturing processes strictly comply with ISO 13485 and CDSCO requirements.

Challenge 4: Responding to CDSCO Queries

Solution: Assign a dedicated regulatory liaison to handle queries promptly and provide clear, evidence-backed responses.

Expert Consultation and Support

Navigating CDSCO licensing for Mammary Biopsy Needles can be complex due to stringent requirements and regulatory scrutiny. Leveraging expertise from consultants with 25+ years’ experience and a track record of 500+ successful licenses can significantly expedite your approval process. We provide end-to-end support:

• Gap analysis and readiness assessment
• Document preparation and review
• Liaison with notified bodies and CDSCO officials
• Audit preparation and training
• Query handling and compliance follow-up

Getting Started with Your CDSCO License Application

1. Assess your device classification and license type – For Mammary Biopsy Needle, confirm Class B and MD5 license applicability.
2. Prepare your facility – Ensure your manufacturing premises meet regulatory standards and hire qualified technical staff.
3. Apply for Test License (MD13) – Submit your application on the CDSCO MD Online Portal to begin product testing.
4. Collect and organize documentation – Develop comprehensive Device Master File, Plant Master File, and other required dossiers.
5. Engage a notified body early – Schedule audits and pre-audit consultations.
6. Submit your manufacturing license application (Form MD3) – Once test reports and documents are ready.
7. Prepare for audit and query management – Maintain responsiveness and transparency with CDSCO and auditors.

By following these practical steps and leveraging professional support, your Mammary Biopsy Needle manufacturing license in India can be obtained efficiently and compliantly.

For further assistance or personalized consultancy, please contact us to leverage our proven expertise in CDSCO licensing.

References:

• Apply and track your application through the CDSCO MD Online Portal
• Find approved labs on the Testing Laboratories list
• Identify notified bodies for audits on the Notified Bodies List
• Explore our detailed MD5 License Guide
• Enhance your quality system with insights from our Risk Management guide