CDSCO License for Physical therapy ultrasound/neuro muscular stimulation system

Comprehensive Guide to CDSCO Licensing for Physical Therapy Ultrasound/Neuro Muscular Stimulation Systems (Class B)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the physical therapy ultrasound/neuro muscular stimulation system. As a device designed to facilitate rhythmic contraction and release of injured muscles with ultrasound treatment, this Class B neurological device requires a specific licensing pathway under the Central Drugs Standard Control Organization (CDSCO).

With over 25 years of experience and having supported 500+ companies secure their CDSCO licenses, we understand the nuances involved in this process. This guide offers an in-depth look at every step required to obtain your manufacturing or import license for this device type, ensuring you meet compliance efficiently.

CDSCO Regulatory Framework for Physical Therapy Ultrasound/Neuro Muscular Stimulation Systems

The CDSCO regulates medical devices under the Medical Device Rules, 2017, classifying devices based on risk. Your device falls under Class B (low to moderate risk) and the neurological category, as per Notification 29/Misc/03/2020-DC (201) dated 27.09.2021.

Compliance with the Essential Principles of Safety and Performance is mandatory. The device must adhere to applicable Indian standards and international norms (ISO 13485, IEC standards for ultrasound devices).

Risk Classification and License Requirements

Class B devices require an MD5 Manufacturing License granted by the State Licensing Authority. This license ensures your manufacturing processes meet quality and safety standards. For importers, the process differs and requires an MD15 Import License from the Central Licensing Authority.

For your physical therapy ultrasound/neuro muscular stimulation system, the MD5 license is mandatory if manufacturing in India.

Manufacturing License Process (MD5 License)

The MD5 license process involves several critical steps:

1. Apply for Test License (Form MD13): Before the actual manufacturing license, a test license is required to conduct product testing.
2. Product Testing: Get your device tested at government-approved laboratories to verify compliance. A list of these labs is available on the CDSCO Testing Laboratories list.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System documentation.
4. Submit Manufacturing License Application (Form MD3): File your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A mandatory audit by a notified body assesses your manufacturing facility’s compliance. Check the list of notified bodies authorized for this audit.
6. Resolve Queries: Address any queries or observations raised by the CDSCO or notified body.
7. License Grant: Upon successful completion, the MD5 license is granted.

Manufacturing License Documents Required

To streamline your application, ensure you have the following:

• Company Constitution/Registration Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Certificates of Qualification for Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File detailing design, components, and performance (Device Master File Guide)
• Plant Master File covering infrastructure and equipment (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from accredited labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 compliant)

Import License Process (MD15 License)

If you plan to import the physical therapy ultrasound system, the MD15 license from the Central Licensing Authority is required. The process is as follows:

1. Document Preparation: Collect all necessary certificates including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, and Device/Plant Master Files.
2. Submit Application (Form MD14): File through the CDSCO MD Online Portal.
3. Respond to Queries: Address any questions from CDSCO.
4. Grant of License (Form MD15): Upon satisfactory review.

Import License Documents Required

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

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total. This includes 1.5-2 months for test license and product testing, followed by document submission, audit, and license grant.
• MD15 Import License: Approximately 5-6 months from application to grant.

Government Fees and Costs

• MD5 License: Rs 5000 per application + Rs 500 per product.
• MD15 Import License: Fees vary by class; for Class B devices like yours, expect around Rs 2000 per site + Rs 1000 per product.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or discrepancies in technical files.

Solution: Engage experienced regulatory consultants early. Utilize templates for Device and Plant Master Files to ensure completeness. Our Device Master File guide and Plant Master File guide provide step-by-step assistance.

Challenge: Audit non-compliance due to inadequate quality systems.

Solution: Implement and maintain ISO 13485:2016 QMS before application. Conduct internal audits to identify gaps.

Challenge: Prolonged product testing timelines.

Solution: Choose accredited government labs with proven turnaround times. Check the latest Testing Laboratories list.

Expert Consultation and Support

Our team has successfully guided over 500 companies through the CDSCO licensing maze for neurological devices like yours. We offer tailored consulting, document preparation, audit support, and liaison with regulatory authorities to expedite approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class B using resources like the Medical Device Classification guide.
2. Prepare Technical Documentation: Start compiling Device and Plant Master Files alongside risk management and QMS documents.
3. Apply for Test License (if manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.
4. Initiate Product Testing: Coordinate with notified testing laboratories.
5. Schedule Audit: Identify notified bodies from the official list to plan your facility audit.
6. Submit Manufacturing License Application (Form MD3): Upon successful testing and audit readiness.

Embarking on the CDSCO licensing pathway may seem daunting, but with proper planning and expert guidance, your physical therapy ultrasound/neuro muscular stimulation system can achieve timely market access in India. Reach out to us today to leverage our extensive experience and ensure a smooth regulatory journey.