CDSCO License for Circulating-fluid thermal therapy system

Comprehensive Guide to CDSCO Licensing for Circulating-Fluid Thermal Therapy Systems (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ manufacturers and importers through the CDSCO licensing process, we understand the nuances involved in bringing medical devices like the Circulating-fluid thermal therapy system to the Indian market. This device, classified as Risk Class B under the Rehabilitation category, is intended for localized hot and cold therapy using heated or cooled fluids, playing a vital role in managing musculoskeletal injuries.

Navigating the regulatory landscape for such devices is critical to ensure compliance, timely market access, and sustained business growth. Below, we provide an in-depth, actionable roadmap tailored specifically for this device type and risk class.

CDSCO Regulatory Framework for Circulating-Fluid Thermal Therapy Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices under the Medical Device Rules, 2017. Circulating-fluid thermal therapy systems fall under Class B due to their moderate risk profile. Therefore, the regulatory pathway primarily involves obtaining a Manufacturing License (MD5) if you plan to manufacture locally, or an Import License (MD15) if you are importing the device.

Indian regulations mandate compliance with quality standards such as ISO 13485:2016 and adherence to essential principles of safety and performance. The device must also be registered under the relevant CDSCO notification – in this case, File No. 29/Misc./03/2020-DC (160), dated 04.08.2022.

Risk Classification and License Requirements

• Device: Circulating-fluid thermal therapy system
• Risk Class: B (Moderate Risk)
• License Required: MD5 (Manufacturing License) for domestic production
• Authority: State Licensing Authority
• Regulatory Forms:
  • Test License: Form MD13
  • Manufacturing License Application: Form MD3
  • Final License Issuance: Form MD5

Manufacturers must first obtain a Test License before the final manufacturing license is granted. The test license allows for initial product testing in government-approved laboratories.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process is multi-step and typically takes 3 to 4 months from start to finish. Here’s a practical breakdown:

1. Obtain Test License (Form MD13): Application submitted via the CDSCO MD Online Portal. Processing time is around 1.5 to 2 months.

2. Product Testing: Conduct mandatory product tests in government-recognized labs listed on the Testing Laboratories page. For circulating-fluid thermal therapy systems, tests usually include electrical safety, biocompatibility, and performance validation.

3. Prepare Documents: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.

4. Apply for Manufacturing License (Form MD3): Submit the application with all supporting documents through the CDSCO MD Online Portal.

5. Audit by Notified Body: The State Licensing Authority will coordinate an audit by a notified body. Check the Notified Bodies list to identify the authorized auditors.

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

7. License Grant (Form MD5): Upon successful review and audit clearance, the manufacturing license is issued.

Manufacturing License Documents Required

For a Class B device like the circulating-fluid thermal therapy system, documentation must be thorough and precise. Key documents include:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Appointment and Qualification Certificates of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation. Our Device Master File guide provides a step-by-step approach.
• Plant Master File (PMF): Details of manufacturing facility and equipment. Refer to our Plant Master File Guide.
• Essential Principles Checklist demonstrating compliance with CDSCO safety and performance requirements
• Risk Management File showing hazard analysis and mitigation strategies
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation, typically ISO 13485:2016 certification and associated processes

Import License Process (MD15) for Circulating-Fluid Thermal Therapy Systems

If you plan to import this device, the MD15 Import License issued by the Central Licensing Authority is mandatory. The process takes approximately 5 to 6 months and includes:

1. Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and DMF/PMF.
2. Submission of application through the CDSCO MD Online Portal.
3. Review and resolution of queries from the licensing authority.
4. Final issuance of the Import License (Form MD15).

Note that test licenses are not required for import applications. However, the application must be comprehensive to avoid delays.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if the device is CE marked)
• Device Master File and Plant Master File
• Wholesale License of the Indian importer
• Company Constitution
• Product labels and IFU

Timeline and Processing Duration

For import licenses (MD15), the total time is generally 5 to 6 months due to additional central authority reviews.

Government Fees and Costs

• MD5 Manufacturing License (Class B):

  • Application Fee: Rs 5,000 per application
  • Product Fee: Rs 500 per product

• MD15 Import License (Class B):

  • Site Fee: $2,000 per site
  • Product Fee: $1,000 per product

Budgeting for these fees upfront along with costs for testing, notified body audits, and document preparation is essential. We recommend engaging experienced consultants to optimize cost and time.

Common Challenges and Solutions

Challenge: Delays in test reports from approved labs.

• Solution: Engage with labs early and schedule tests promptly. Use the Testing Laboratories list to select accredited facilities.

Challenge: Incomplete or inconsistent documentation.

• Solution: Follow standardized templates for Device Master File and Plant Master File. Our guides and checklists can streamline this phase.

Challenge: Audit non-conformities.

• Solution: Conduct internal audits and pre-audit assessments before the notified body visit. Training your technical and quality staff is crucial.

Challenge: Query resolution delays.

• Solution: Respond promptly with clear, evidence-backed replies. Maintain open communication with CDSCO officers.

Expert Consultation and Support

With decades of experience, we provide end-to-end support including:

• Gap analysis and readiness assessments
• Document drafting and review
• Liaison with notified bodies and CDSCO authorities
• Training for your team on regulatory compliance

Our hands-on approach has helped over 500 companies successfully navigate the CDSCO licensing pathway.

Getting Started with Your CDSCO License Application

1. Evaluate your device classification: Confirm your device is Class B using the Medical Device Classification resource.

2. Register on the CDSCO MD Online Portal: Begin your application through the official CDSCO MD Online Portal.

3. Plan and schedule product testing: Identify government-approved labs early and initiate testing.

4. Prepare Device Master File and Plant Master File: Use our comprehensive guides to ensure compliance.

5. Engage a notified body for audit: Select from the list of notified bodies authorized for Class B device audits.

6. Compile and submit your application: Complete Form MD13 for test license and subsequently Form MD3 for manufacturing license.

7. Prepare for audit and query response: Train your team and maintain readiness for inspection.

By following these actionable steps and leveraging expert support, your journey to obtaining the CDSCO MD5 license for your circulating-fluid thermal therapy system can be smooth, timely, and cost-effective.

Feel free to reach out to our team for personalized consultation tailored to your device and business needs.