CDSCO License for Gait- enhancement electrical stimulation  system, external

Comprehensive Guide to CDSCO Licensing for Gait-Enhancement Electrical Stimulation Systems (Class B)

At our consultancy, with over 25 years of experience and having guided more than 500 companies through the complex regulatory landscape in India, we understand the unique challenges manufacturers and importers face when seeking CDSCO licenses for devices like the Gait-enhancement electrical stimulation system, external. This neurological device, classified as Class B, is crucial for improving gait in patients with partial paralysis or neuromuscular disorders, making regulatory compliance vital for market access and patient safety.

CDSCO Regulatory Framework for Gait-Enhancement Electrical Stimulation Systems

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The Gait-enhancement electrical stimulation system falls under the neurological device category and is notified by CDSCO under Notification 29/Misc/03/2020-DC (201), dated 27.09.2021. Given its risk classification as Class B, the device requires a manufacturing license (MD5) issued by the State Licensing Authority and an import license (MD15) granted by the Central Licensing Authority.

Risk Classification and License Requirements

• Risk Class: B (Low to moderate risk)
• Manufacturing License: MD5 License (Application Form MD3)
• Import License: MD15 License (Application Form MD14)

Class B devices like the Gait-enhancement electrical stimulation system require compliance with specific documentation, testing, and audit processes to ensure safety and efficacy.

Manufacturing License Process (MD5)

The MD5 license process involves several critical steps:

1. Test License (Form MD13): Before full manufacturing approval, you must obtain a test license, which typically takes 1.5 to 2 months. This license allows you to produce limited quantities for testing.

2. Product Testing: Mandatorily done at CDSCO-approved government testing laboratories. Testing validates compliance with essential safety and performance standards.

3. Documentation Preparation: Prepare a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, and other mandatory documents.

4. Application Submission: Submit Form MD3 via the CDSCO MD Online Portal for the MD5 license.

5. Audit by Notified Body: An audit from a notified body listed on the Notified Bodies List is required to verify your manufacturing processes and quality system.

6. Query Resolution: Address any queries raised by the State Licensing Authority or the notified body.

7. Grant of License: Upon satisfactory evaluation, the MD5 license is issued on Form MD5.

Timeline for MD5 Process

• Test License: 1.5–2 months
• Product Testing: 2–3 weeks (can vary depending on lab workload)
• Application Review and Audit: 1.5–2 months
• Total Time: Approximately 3 to 4 months

Manufacturing License Documents Required

For a Class B device such as this, prepare the following documentation:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – Detailed design and manufacturing info (refer to our comprehensive Device Master File guide)
• Plant Master File (PMF) – Facility details (see our Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
• Risk Management File aligned with ISO 14971 standards (Risk Management Guide)
• Test Reports from CDSCO-approved labs (Testing Laboratories List)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Certificates and Documentation (ISO 13485:2016 preferred)

Import License Process (MD15)

For importers of the Gait-enhancement electrical stimulation system, the MD15 import license process involves:

1. Document Compilation: Collect all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), and detailed Device and Plant Master Files.

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

3. Review and Query Resolution: The Central Licensing Authority reviews the application and may raise queries that need prompt resolution.

4. License Grant: Upon successful review, the MD15 import license is granted.

Timeline for MD15 Process

• Document Preparation: Variable (typically 1 month)
• Application Processing: 4 to 5 months
• Total Time: Approximately 5 to 6 months

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certificate
• CE Certificate or other relevant conformity certificates
• Device Master File
• Plant Master File
• Wholesale License in India (if applicable)
• Company Constitution/Registration Certificate

Government Fees and Costs

• Class B: $2,000 per site
• Product: $1,000 each | Central Licensing Authority |

Note: The above fees are indicative. Currency conversions fluctuate; always check current rates.

Common Challenges and Practical Solutions

• Delay in Testing: Government labs can have backlogs. Plan testing early and consider multiple labs from the approved list to avoid bottlenecks.
• Documentation Gaps: Missing or incomplete Device Master Files or Risk Management Files are common rejection causes. Utilize our detailed templates and guides to ensure completeness.
• Audit Non-compliance: Notified body audits can be rigorous. Conduct internal mock audits and maintain robust QMS documentation.
• Query Delays: Prompt, clear responses to CDSCO queries accelerate approval. Assign dedicated personnel for follow-ups.

Expert Consultation and Support

Navigating CDSCO licensing for the Gait-enhancement electrical stimulation system can be intricate. Our team’s extensive experience with over 500 successful approvals means we can:

• Prepare and review your Device and Plant Master Files
• Facilitate liaison with testing laboratories and notified bodies
• Provide audit readiness training
• Manage application submissions and query responses

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s Class B status through the Medical Device Classification tool.

2. Initiate Test License (MD13): Submit your test license application promptly through the CDSCO MD Online Portal.

3. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File using expert templates.

4. Plan Testing: Book slots at CDSCO-approved labs early.

5. Schedule Notified Body Audit: Contact a notified body from the official list to arrange your audit.

6. Submit Full License Application: After testing and audit, upload the complete dossier via the online portal.

7. Monitor and Respond: Assign a regulatory liaison to promptly handle any queries from CDSCO.

Engage with us early to streamline your CDSCO license journey. Our tailored strategies ensure your Gait-enhancement electrical stimulation system enters the Indian market swiftly and compliantly.