CDSCO License for Transcranial  electrical stimulation system, continuous- current and pulsed-current

Comprehensive Guide to CDSCO Licensing for Transcranial Electrical Stimulation Systems (Class B)

Transcranial electrical stimulation systems, delivering continuous or pulsed currents such as transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), represent cutting-edge neurological devices. They are primarily intended for psychiatric and neurological therapies, including inducing anesthesia-like states for managing anxiety, depression, insomnia, and addiction. Given their specialized use and risk profile, these devices fall under Class B as per Indian regulatory classification.

At our consultancy, with over 25 years of experience helping 500+ companies secure CDSCO licenses, we understand the nuances of navigating the regulatory landscape for such devices. This guide offers a detailed roadmap for manufacturers and importers seeking CDSCO approval for transcranial electrical stimulation systems.

CDSCO Regulatory Framework for Transcranial Electrical Stimulation Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, amended periodically. Devices like transcranial electrical stimulation systems are classified as Class B due to their moderate risk level and neurological application.

Compliance with the MDR ensures that devices meet safety, quality, and performance standards before entering the Indian market. The relevant notification for this device category is 29/Misc/03/2020-DC (201) dated 27.09.2021.

Risk Classification and License Requirements for Class B Devices

According to the CDSCO classification, Class B devices require an MD5 license, which is granted by the State Licensing Authority. The MD5 license process includes obtaining a test license (MD13), product testing in government-approved laboratories, a notified body audit, and finally, license grant.

This process is specifically designed to ensure moderate-risk devices like transcranial electrical stimulation systems comply with essential principles and quality standards before market entry.

Manufacturing License Process for Transcranial Electrical Stimulation Systems (MD5 License)

1. Test License (Form MD13): The initial step involves applying for a test license to manufacture the device for testing purposes. This license is valid for 3 months and takes approximately 1.5 to 2 months to be granted.

2. Product Testing: Samples of the device must be tested in CDSCO-approved laboratories. Testing covers safety, electromagnetic compatibility, and performance parameters. You can find the list of CDSCO-approved testing labs here.

3. Document Preparation: While testing proceeds, prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. License Application (Form MD3): Submit the manufacturing license application with all supporting documents and test reports on the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a plant audit to verify compliance with manufacturing and quality standards. Manufacturers can refer to the list of notified bodies for audit assignments.

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

7. Grant of MD5 License: Upon satisfactory completion of the audit and document review, the MD5 manufacturing license is issued.

Manufacturing License Documents Required

For a Class B device like the transcranial electrical stimulation system, the following documents are essential:

• Company Constitution (e.g., Memorandum of Association, Partnership Deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualifications and Experience of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance
• Risk Management File evidencing hazard analysis and mitigation measures (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certified

Import License Process for Transcranial Electrical Stimulation Systems (MD15 License)

For importers, the MD15 license granted by the Central Licensing Authority is mandatory before device distribution in India. The process involves:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license.
• Submission of application on the CDSCO MD Online Portal using Form MD14.
• Resolution of any queries raised by the CDSCO.
• Issuance of the MD15 import license.

Note that unlike manufacturing, import licensing does not require a test license or product testing in India but mandates stringent documentation to ensure device conformity.

Import License Documents Required

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

Timeline and Processing Duration

• MD5 License (Manufacturing): Approximately 3 to 4 months, including 1.5 to 2 months for test license issuance and product testing.
• MD15 License (Import): Approximately 5 to 6 months from application submission to license grant.

These timelines can vary based on document completeness, timely audit scheduling, and query resolution efficiency.

Government Fees and Costs

MD5 License fees for Class B devices:

• Rs 5,000 per application
• Rs 500 per product

Additional costs include notified body audit fees (typically INR 50,000 to 1,00,000 depending on scope) and laboratory testing fees.

MD15 Import license fees:

• Rs 3,000 per site
• Rs 1,500 per product

Manufacturers and importers should budget for these fees alongside internal resource allocation for document preparation and compliance activities.

Common Challenges and Practical Solutions

• Delayed Test License Issuance: Pre-prepare all technical documents to avoid bottlenecks; engage experienced consultants for accurate submissions.
• Audit Non-Conformities: Conduct internal mock audits and maintain robust QMS to streamline notified body audits.
• Document Gaps: Utilize comprehensive checklists and templates for Device Master and Plant Master Files to ensure completeness.
• Query Resolution Delays: Assign dedicated personnel to respond promptly to CDSCO or notified body queries.

Expert Consultation and Support

Given the technical and regulatory complexity of Class B neurological devices, expert guidance is invaluable. Our team has successfully supported over 500 companies, providing end-to-end services including document preparation, liaison with CDSCO authorities, audit facilitation, and post-approval compliance.

We recommend early engagement with consultants familiar with transcranial electrical stimulation systems and neurological device classification to minimize delays and compliance risks.

Getting Started with Your CDSCO License Application

1. Verify Device Classification: Confirm your device’s risk class as Class B by cross-checking the CDSCO Medical Device Classification.

2. Prepare Test License Application: Gather technical documents and apply for the MD13 test license on the CDSCO MD Online Portal.

3. Plan Product Testing: Coordinate with CDSCO-approved laboratories early to schedule testing.

4. Compile Comprehensive Documentation: Develop Device Master File, Plant Master File, Risk Management File, and QMS documents using our detailed guides.

5. Schedule Notified Body Audit: Identify an appropriate notified body and prepare your facility for audit.

6. Submit MD5 License Application: After successful testing and audit readiness, apply for the manufacturing license (Form MD3).

7. Monitor Application Progress: Track and respond to queries promptly to ensure timely license grant.

Launching your transcranial electrical stimulation system in India requires careful planning and regulatory diligence. With our proven expertise, you can confidently navigate the CDSCO licensing process and bring your innovative neurological device to market.

For personalized assistance, reach out to our regulatory experts today.