CDSCO License for Musculoskeletal intense therapeutic ultrasound system

Comprehensive CDSCO Licensing Guide for Musculoskeletal Intense Therapeutic Ultrasound Systems (Class C)

Entering the Indian market with a Musculoskeletal Intense Therapeutic Ultrasound System — a sophisticated rehabilitation device designed to create ablative lesions in subcutaneous soft tissues — requires meticulous adherence to the Central Drugs Standard Control Organisation (CDSCO) regulatory framework. As specialists with over 25 years of experience assisting 500+ companies, we provide you with a detailed roadmap for obtaining the MD9 manufacturing license for this Class C medical device.

Understanding Your Device and Its Regulatory Importance

Your device, classified as Class C under the CDSCO risk classification system, carries a moderate to high risk due to its invasive therapeutic application. The intense therapeutic ultrasound system delivers focused ultrasound waves to muscles and tendons, making regulatory compliance critical to ensure patient safety and efficacy.

Proper licensing is not merely a legal requirement but a cornerstone for market trust, enabling smooth import, manufacturing, and sale in India. The CDSCO notification (File No. 29/Misc./03/2020-DC (160), dated 04.08.2022) formally recognizes this device category, reinforcing the need for a robust regulatory strategy.

CDSCO Regulatory Framework for Musculoskeletal Intense Therapeutic Ultrasound Systems

The regulatory oversight for your Class C device falls under the Central Licensing Authority. The key licensing form applicable is MD9, which regulates the manufacturing of medium to high-risk medical devices.

Before applying for the MD9 license, manufacturers must obtain a test license (Form MD13) to initiate product testing in government-approved laboratories. This two-step approach ensures devices meet essential principles of safety, quality, and performance.

Risk Classification and License Requirements

• Risk Class: C (Moderate to high risk)
• Regulatory Authority: Central Licensing Authority, CDSCO
• Required License: MD9 (Form MD7 application)
• Pre-requisite: Test License (Form MD13)

For detailed risk classifications, visit our Medical Device Classification guide.

Manufacturing License Process (MD9)

1. Test License Application (Form MD13): The initial step involves submitting a test license application through the CDSCO MD Online Portal. This license allows you to manufacture limited samples for testing.

2. Product Testing: After receiving the test license (typically within 1.5 to 2 months), you must get your device tested at CDSCO-approved laboratories. Refer to the Testing Laboratories list for authorized facilities.

3. Documentation Preparation: Parallel to testing, assemble comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) records. Our Device Master File guide and Plant Master File guide provide actionable templates.

4. Submission of MD9 License Application (Form MD7): Upload the completed application with all supporting documents on the MD Online Portal.

5. CDSCO Inspection and Audit: A CDSCO inspector will audit your manufacturing site and documentation. Prepare for this by reviewing the list of notified bodies and ensuring your notified body audit (if applicable) is complete.

6. Queries Resolution: Respond promptly and accurately to any queries raised by CDSCO during the evaluation.

7. Grant of MD9 License: Upon satisfactory review and audit, CDSCO issues the license in Form MD9, enabling full-scale manufacturing.

Manufacturing License Documents Required

For your Class C device, prepare the following:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) — detailed device specifications, design, and manufacturing processes
• Plant Master File (PMF) — facility layout, equipment details, and quality systems
• Essential Principles Checklist confirming compliance with CDSCO regulations
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Product Test Reports from approved laboratories
• Labeling Samples, Instructions for Use (IFU), and Packaging Details
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15)

If you plan to import the Musculoskeletal Intense Therapeutic Ultrasound System, obtain the MD15 import license from CDSCO’s Central Licensing Authority. This process does not require a test license but demands:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device and Plant Master Files
• Wholesale License
• Company Constitution

The application is submitted via the CDSCO MD Online Portal, with an expected timeline of 5-6 months.

For detailed import procedures, consult our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (depending on lab capacity)
• Document Preparation: Concurrent; typically 1 month
• MD9 License Application & Audit: 2 to 3 months
• Total Duration: Approximately 4 to 5 months from start to finish

Government Fees and Costs

• MD9 License Application Fee: ₹50,000 per application
• Per Product Fee: ₹1,000 per product variant
• Test License Fee: Included in initial application costs

Additional costs may include laboratory testing fees (varies by test complexity) and notified body audit charges.

Common Challenges and Solutions

Challenge 1: Delay in product testing due to limited slots at approved labs.

Solution: Schedule testing well in advance and consider multiple approved labs listed on the Testing Laboratories portal.

Challenge 2: Non-compliance in documentation, especially risk management and essential principles.

Solution: Engage experts early to develop compliant DMF, PMF, and risk files. Our Risk Management resource provides in-depth guidance.

Challenge 3: Audit readiness and query resolution delays.

Solution: Prepare thoroughly by conducting internal audits and mock inspections. Respond to queries swiftly with well-documented evidence.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, but with our 25+ years of experience and 500+ successful client engagements, we offer tailored consultancy that simplifies the process. From initial classification to audit preparation and post-approval compliance, we guide you every step of the way.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device risk class as Class C.
2. Register on the CDSCO MD Online Portal: Create your account to initiate applications.
3. Prepare Preliminary Documentation: Begin compiling your DMF, PMF, and QMS documents.
4. Apply for Test License (MD13): Submit your test license application promptly to start product testing.
5. Engage with a CDSCO-Recognized Testing Laboratory: Schedule testing early to avoid bottlenecks.
6. Plan for Audit and Inspection: Select notified bodies and prepare your manufacturing site.
7. Submit MD9 License Application (Form MD7): Once testing is complete, apply for the manufacturing license.

Start your application today via the CDSCO MD Online Portal. For personalized assistance, contact our regulatory experts to ensure a smooth, compliant, and timely approval process for your Musculoskeletal Intense Therapeutic Ultrasound System.