CDSCO License for Medium-wave diathermy treatment system

Comprehensive Guide to CDSCO Licensing for Medium-wave Diathermy Treatment Systems (Class B Medical Device)

Medium-wave diathermy treatment systems are sophisticated rehabilitation devices designed to deliver therapeutic deep heat by transcutaneously transmitting electromagnetic energy within the radio-frequency bands of 0.5 MHz to 1 MHz. Widely used in physiotherapy and rehabilitation clinics, these devices facilitate pain relief and tissue healing.

As specialists with over 25 years of experience and having supported more than 500 companies in obtaining CDSCO licenses, we understand the nuances involved in securing regulatory approval for such devices in India. This guide outlines the critical regulatory framework, application procedures, timelines, fees, and documentation requirements specifically for your Medium-wave Diathermy Treatment System, classified as a Class B device under the CDSCO.

CDSCO Regulatory Framework for Medium-wave Diathermy Treatment Systems

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, efficacy, and compliance with essential principles. Your device falls under the rehabilitation category and is notified under File No. 29/Misc./03/2020-DC (160), dated 04.08.2022.

Being a Class B device, regulatory oversight primarily comes from the State Licensing Authority for manufacturing licenses, while import licenses are handled by the Central Licensing Authority.

Manufacturers or importers must comply with:

• The Medical Device Rules, 2017
• Relevant Indian Standards for safety and performance
• Documentation on Quality Management Systems (ISO 13485:2016 recommended)

This regulatory framework ensures that the medium-wave diathermy systems entering the Indian market meet international safety and quality benchmarks.

Risk Classification and License Requirements for Class B Medical Devices

The Medical Device Classification system categorizes your device as Class B due to its moderate risk profile.

License Type Required: MD5 Manufacturing License

• Issued by the State Licensing Authority
• Application submitted via the CDSCO MD Online Portal

For importers, the MD15 Import License from the Central Licensing Authority is mandatory.

Manufacturing License Process for Medium-wave Diathermy Systems (MD5)

The MD5 license process is a multi-step journey:

1. Test License (Form MD13): Initiate by applying for a test license, which takes approximately 1.5 to 2 months. This license permits you to manufacture and test the device prototype.

2. Product Testing: Conduct mandatory testing at government-approved labs listed on the CDSCO portal under Testing Laboratories, focusing on electrical safety, electromagnetic compatibility, and performance.

3. Documentation Preparation: Compile comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit the MD5 application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body from the official list of notified bodies will perform an on-site audit of your manufacturing facility.

6. Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body.

7. License Grant: Upon successful compliance, the MD5 license is granted.

The entire process generally spans 3 to 4 months, contingent on prompt compliance and documentation.

Manufacturing License Documents Required for MD5

Accurate and complete documentation is essential:

• Company Constitution: Certificate of Incorporation and Memorandum & Articles of Association
• Proof of Premises Ownership or Lease: Legal documents confirming manufacturing site
• Technical Staff Documents: Qualification certificates and experience proof of key technical personnel
• Fire NOC and Pollution Control NOC: Approvals from local fire and pollution authorities
• Device Master File (DMF): Detailed device specifications, manufacturing process, and design controls (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment details, and manufacturing environment (Plant Master File Guide)
• Essential Principles Checklist: Compliance checklist ensuring conformity to Indian Medical Device Rules
• Risk Management File: Risk analysis, evaluation, and mitigation strategies based on ISO 14971 (Risk Management)
• Test Reports: Results from government-approved testing laboratories
• Labels and Instructions for Use (IFU): Samples demonstrating compliance with labeling regulations
• Quality Management System (QMS) Documents: Procedures, SOPs, and records as per ISO 13485:2016

Import License Process for Medium-wave Diathermy Systems (MD15)

For importers, the MD15 license from the Central Licensing Authority is mandatory. The process involves:

1. Preparation of Documents: Assemble required certificates such as Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File,

2. Application Submission: Submit Form MD14 on the CDSCO MD Online Portal.

3. Review and Query Resolution: The CDSCO evaluates the application and may request clarifications.

4. License Issuance: After satisfying all requirements, the MD15 license is granted.

The import license process typically takes 5 to 6 months.

Import License Documents Required

Key documents include:

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

Timeline and Processing Duration

Planning your application timeline with these durations in mind is crucial to avoid market entry delays.

Government Fees and Costs

For your Class B Medium-wave Diathermy Treatment System:

• MD5 Manufacturing License:

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

• Test License (MD13): Fees vary, but typically included within the application cost

• Import License (MD15):

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

Note that these fees are subject to updates by CDSCO; always verify during application.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete documentation or non-compliance during audits.

Solution: Engage with experienced consultants early. Prepare your Device Master File and Plant Master File meticulously. Use checklists like the Essential Principles Checklist to ensure compliance.

Challenge: Difficulty in obtaining test reports from approved laboratories.

Solution: Coordinate with CDSCO-approved testing laboratories well in advance. Schedule testing slots early to accommodate possible retests.

Challenge: Addressing queries from CDSCO or notified bodies.

Solution: Maintain open communication channels. Provide clear, evidence-based responses supported by documentation.

Expert Consultation and Support

With our 25+ years of regulatory consulting experience, we have guided over 500 companies through the CDSCO licensing maze. Our services include:

• Comprehensive gap analysis of your current documentation
• Assistance in preparing Device Master File and Plant Master File
• Coordination with notified bodies and testing labs
• End-to-end application filing and follow-up
• Post-approval compliance support

Partnering with experts can significantly reduce approval time and ensure hassle-free market entry.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class B and eligible for MD5 licensing.

2. Register on the CDSCO MD Online Portal: Begin your journey by creating a profile on the official CDSCO portal.

3. Apply for Test License (MD13): Submit form MD13 to get approval for initial manufacturing and testing.

4. Plan Product Testing: Coordinate with government-approved labs early to avoid scheduling bottlenecks.

5. Prepare Documentation: Use our Device Master File Guide and Plant Master File Guide as templates.

6. Schedule and Prepare for Audit: Select a notified body from the CDSCO notified bodies list and ensure your facility complies fully.

7. Submit Manufacturing License Application (MD3): File your MD5 license application through the portal.

8. Respond Promptly to Queries: Keep documentation and technical teams ready for efficient responses.

By taking these actionable steps, you can streamline the licensing process and bring your Medium-wave Diathermy Treatment System to the Indian market confidently and compliantly.

For personalized assistance and to accelerate your CDSCO licensing journey, contact us today to leverage our proven expertise.