CDSCO License for Microwave diathermy treatment system

Comprehensive Guide to CDSCO Licensing for Microwave Diathermy Treatment System (Class B Medical Device)

Microwave Diathermy Treatment Systems are advanced rehabilitation devices designed to deliver therapeutic heat beneath the skin surface using high-frequency electromagnetic energy, typically at 2,450 MHz. This transcutaneous application promotes tissue healing and pain relief, making it a vital tool in physiotherapy and rehabilitation clinics. Given its medical significance and electromagnetic energy use, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory before market entry in India.

With over 25 years of experience and more than 500 successful CDSCO license procurements, we provide a detailed roadmap to help manufacturers and importers navigate the CDSCO licensing process specifically for this Class B device.

CDSCO Regulatory Framework for Microwave Diathermy Treatment Systems

The CDSCO regulates medical devices based on risk classification and intended use, as outlined in the Medical Device Rules, 2017. Microwave Diathermy Treatment Systems fall under Class B (low-moderate risk) due to the non-invasive, therapeutic nature of the device and its electromagnetic radiation use.

This classification mandates obtaining an MD5 Manufacturing License from the State Licensing Authority if manufacturing in India, or an MD15 Import License from the Central Licensing Authority for importers.

The device is notified under File No. 29/Misc./03/2020-DC (160) dated 04.8.2022, ensuring the regulatory framework applies explicitly to it.

Risk Classification and License Requirements

• Device: Microwave Diathermy Treatment System
• Risk Class: B (low to moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority

For manufacturers:

• Test License (Form MD13) is required initially for product testing from government-approved labs.
• Post-testing and audit, the MD5 license is granted.

For importers:

• MD15 license from CDSCO Central Licensing Authority is required.

Understanding this classification aids in selecting the correct application route and preparing the necessary documentation.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process is comprehensive but structured, ensuring safety and efficacy prior to market release. Here's a stepwise breakdown:

1. Test License Application (Form MD13): Apply on the CDSCO MD Online Portal for the test license, which takes approximately 1.5 to 2 months to be granted.

2. Product Testing: The device must be tested at government-recognized laboratories. Refer to the list of testing laboratories for approved facilities.

3. Document Preparation: Compile all documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, test reports, labels, and Instructions for Use (IFU).

4. Application for MD5 License (Form MD3): Submit the manufacturing license application with the complete dossier.

5. Audit by Notified Body: An audit is conducted by a notified body from the CDSCO Notified Bodies List to verify compliance with quality management systems and manufacturing practices.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.

Total processing time averages 3 to 4 months.

Manufacturing License Documents Required for Microwave Diathermy Treatment System

Ensuring all documentation is accurate and complete minimizes delays. Essential documents include:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical dossier covering design, components, manufacturing processes. Our Device Master File guide helps in preparation.
• Plant Master File (PMF): Details on manufacturing facilities and quality control. See our Plant Master File guide for best practices.
• Essential Principles Checklist: A self-declaration ensuring conformity with fundamental safety and performance requirements.
• Risk Management File: Documentation of hazard analysis and mitigation strategies as per ISO 14971. Our Risk Management guide can assist.
• Test Reports: Results from government-approved labs confirming compliance with relevant standards.
• Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
• Quality Management System (QMS) Documentation: ISO 13485 certification and internal SOPs.

Import License Process (MD15) for Microwave Diathermy Treatment System

For importers, the MD15 license is mandatory and is issued by the CDSCO Central Licensing Authority. The key steps include:

1. Document Preparation: Collect all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.

2. Application Submission: File application using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any departmental queries.

4. License Grant: The MD15 import license is typically granted within 5 to 6 months.

Import License Documents Required

• Valid manufacturing license of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale License
• Company Constitution and Incorporation documents

Timeline and Processing Duration

Planning your submission timeline accordingly can prevent costly project delays.

Government Fees and Costs for MD5 License (Class B Device)

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

These fees are payable via the CDSCO MD Online Portal during application submission.

Common Challenges and Practical Solutions

• Incomplete Documentation: We recommend using comprehensive checklists and templates to ensure no gaps.
• Delays in Testing: Schedule testing early with government-approved labs; maintain regular follow-ups.
• Audit Non-compliance: Pre-audit internal reviews and training of staff reduce audit findings.
• Query Resolution Delays: Assign dedicated regulatory personnel to handle communications promptly.

Our extensive experience enables us to foresee these pain points and proactively mitigate them.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our expert regulatory consultants offer tailored support including:

• Device classification verification
• Document preparation and review
• Test license assistance
• Audit coordination with notified bodies
• Query management and follow-up

Engaging with a seasoned partner significantly improves the chances of timely approval.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device’s classification as Class B under Medical Device Rules.
2. Initiate Test License Application: Begin with Form MD13 on the CDSCO MD Online Portal.
3. Coordinate Product Testing: Book slots with government-approved testing labs early.
4. Prepare Documentation: Utilize our guides for DMF and PMF to streamline dossier creation.
5. Plan for Audit: Select a notified body from the official list here and schedule the audit.
6. Submit MD5 Application: Once testing and documentation are ready, apply using Form MD3.
7. Follow Up: Maintain communication to promptly resolve any queries.

By following these actionable steps and leveraging expert support, manufacturers of Microwave Diathermy Treatment Systems can efficiently secure their CDSCO licenses and ensure regulatory compliance for successful market access in India.