CDSCO License for Diagnostic ultrasonic transducer

Comprehensive Guide to CDSCO Licensing for Diagnostic Ultrasonic Transducers (Class B)

Diagnostic ultrasonic transducers play a pivotal role in modern interventional radiology by converting electrical signals into acoustic waves and vice versa to facilitate precise diagnostic imaging. Given their critical function, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to enter the Indian medical device market.

With over 25 years of experience and having supported 500+ companies, we provide expert insights to help you navigate the CDSCO licensing process smoothly and efficiently for your Class B diagnostic ultrasonic transducer.

CDSCO Regulatory Framework for Diagnostic Ultrasonic Transducers

As per CDSCO notification 29/Misc./03/2020-DC (146) dated 26.07.2021, diagnostic ultrasonic transducers fall under the interventional radiology category and are classified as Class B medical devices. This classification dictates the applicable regulatory pathway, quality requirements, and licensing authorities.

Manufacturers of Class B devices like ultrasonic transducers require an MD5 manufacturing license issued by the State Licensing Authority. Importers will need an MD15 import license granted by the Central Licensing Authority.

For detailed device classification criteria, refer to our Medical Device Classification resource.

Risk Classification and License Requirements for Diagnostic Ultrasonic Transducers

• Risk Class: B (Low to Moderate Risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Authority
• Process Duration: Approximately 3-4 months
• Fees: ₹5,000 per application + ₹500 per product

This classification mandates compliance with essential principles of safety and performance, documented quality management systems, and successful audit by a notified body.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process for diagnostic ultrasonic transducers involves the following sequential steps:

1. Test License Acquisition (Form MD13): Apply for a test license, which permits product testing and validation. This initial step takes about 1.5 to 2 months.

2. Product Testing: Get your transducer tested at CDSCO-approved laboratories to verify compliance with performance and safety standards. Use the list of CDSCO testing laboratories to select an authorized lab.

3. Documentation Preparation: Compile required documents, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.

4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal along with the prescribed fees.

5. Audit by Notified Body: Coordinate with a CDSCO-recognized notified body for an on-site audit of your manufacturing facility. Find an appropriate notified body from the CDSCO Notified Bodies List.

6. Respond to Queries: Address any observations or queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon satisfactory audit and document review, receive your MD5 manufacturing license (Form MD5).

For a step-by-step guide, explore our MD5 License Guide.

Manufacturing License Documents Required for Diagnostic Ultrasonic Transducers

To ensure a smooth application process, prepare the following key documents:

• Company Constitution Documents (e.g., Certificate of Incorporation)
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualifications and Experience
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailing design, specifications, and manufacturing process. See our detailed Device Master File guide.
• Plant Master File (PMF): Information about manufacturing facility and controls. Learn more with our Plant Master File guide.
• Essential Principles Checklist confirming compliance with CDSCO safety standards
• Risk Management File: Demonstrating compliance with ISO 14971 principles. Refer to our Risk Management resource.
• Product Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (e.g., ISO 13485:2016 certification)

Import License Process (MD15) for Diagnostic Ultrasonic Transducers

For importers, the MD15 license is required, which is issued by the Central Licensing Authority. This process generally takes 5-6 months and involves:

• Document preparation including manufacturing license from the country of origin, free sale certificate, ISO 13485:2016 certificate, CE certificate, DMF, PMF, wholesale license, and company constitution.
• Application submission on the CDSCO MD Online Portal.
• Queries resolution with the licensing authority.
• License grant on Form MD15.

Fees vary by risk class, with Class B devices typically charged ₹2000 per site and ₹1000 per product.

For a more detailed understanding, refer to our Import License Guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Per Product Fee: ₹500 per diagnostic ultrasonic transducer model
• Test License Fee (MD13): ₹5,000 (approx.)
• Additional Costs: Fees for notified body audit (varies), product testing fees, documentation consultancy (if applicable)

Common Challenges and Solutions

• Incomplete Documentation: Ensure all documents are current, signed, and formatted as per CDSCO requirements to avoid delays.
• Delayed Test Reports: Coordinate early with approved testing labs; book slots in advance.
• Audit Non-Compliance: Conduct internal pre-audits and gap analysis to prepare your facility and systems.
• Query Resolution Delays: Assign a dedicated regulatory contact to respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our consultancy has successfully assisted over 500 companies in obtaining MD5 and MD15 licenses for Class B devices like diagnostic ultrasonic transducers. We offer:

• Tailored document preparation
• Audit readiness support
• Liaison with notified bodies and CDSCO officials
• Post-licensing compliance guidance

Getting Started with Your CDSCO License Application

1. Assess your Device Classification: Confirm your ultrasonic transducer is Class B under CDSCO.

2. Prepare Essential Documentation: Start compiling your Device Master File, Plant Master File, Risk Management File, and QMS certificates.

3. Apply for Test License (MD13): Submit the test license application via the CDSCO MD Online Portal.

4. Schedule Product Testing: Engage with a CDSCO-approved testing laboratory early.

5. Select Notified Body for Audit: Choose from the list of notified bodies and schedule your audit.

6. Submit Manufacturing License Application (MD3): Once testing and documentation are ready, apply for the MD5 license.

7. Prepare for Queries and Audit: Stay responsive and proactive to facilitate timely license grant.

Embarking on your CDSCO licensing journey with expert guidance ensures compliance, reduces time to market, and positions your diagnostic ultrasonic transducer competitively in India’s burgeoning medical device sector.

For a detailed consultation or to initiate your license application, contact our regulatory experts today.