CDSCO License for Electronystagmo  graph

Comprehensive Guide to CDSCO Licensing for Electronystagmograph (Class B Neurological Device)

As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the critical importance of obtaining the correct CDSCO license to market your medical device in India. The Electronystagmograph, a Class B neurological device used to detect electrical potentials caused by eye movements, falls under specific regulatory scrutiny due to its risk classification and intended use.

Understanding the Regulatory Importance of Electronystagmograph

The Electronystagmograph is an advanced diagnostic device essential in neurological assessments. In India, its regulation by the Central Drugs Standard Control Organization (CDSCO) ensures safety, efficacy, and quality compliance. Failure to secure the appropriate manufacturing or import license can lead to regulatory action, including penalties or product recalls.

CDSCO Regulatory Framework for Electronystagmograph

As per the notification 29/Misc/03/2020-DC (201) dated 27.09.2021, the Electronystagmograph is classified as a Class B device under the Medical Device Rules, 2017. This classification means it is considered a low to moderate risk device and requires adherence to guidelines set out by the CDSCO for such devices.

Manufacturers must apply for the MD5 manufacturing license through the State Licensing Authority, while importers require the MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements

• Device Name: Electronystagmograph
• Risk Class: B (Low to moderate risk)
• Category: Neurological
• License Type: MD5 (Manufacturing) or MD15 (Import)

Given its Class B status, the Electronystagmograph requires an MD5 license for manufacturing within India. This involves a multi-step process including obtaining a test license, product testing, document submission, and audit.

Manufacturing License Process (MD5) for Electronystagmograph

The MD5 license process is managed by the State Licensing Authority and typically spans 3 to 4 months. Here is a stepwise breakdown:

1. Test License (Form MD13): Apply for a test license to legally manufacture and test the device. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Conduct device testing at CDSCO-approved laboratories to validate safety and performance. Testing duration varies but usually takes a few weeks.
3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, risk management, and quality management system documents.
4. License Application (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body from the CDSCO list of notified bodies for an on-site audit.
6. Query Resolution: Address any queries raised by the authorities or notified body during review.
7. License Grant (Form MD5): Upon satisfactory review and audit, the manufacturing license is granted.

Manufacturing License Documents Required for Electronystagmograph

Successful application depends on meticulous documentation. For the Electronystagmograph, prepare the following:

• Company Constitution: Memorandum and Articles of Association or equivalent
• Proof of Premises Ownership or Rent Agreement: Validates manufacturing location
• Technical Staff Qualification Documents: Details of qualified persons responsible for manufacturing
• Fire NOC and Pollution Control NOC: Compliance with safety regulations
• Device Master File (DMF): Detailed product specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Overview of manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist: Compliance with Indian medical device essential principles
• Risk Management File: Risk analysis and mitigation measures (Risk Management)
• Test Reports: From CDSCO-approved testing laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU): Final versions as per regulatory guidelines
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related policies

Import License Process (MD15) for Electronystagmograph

If importing the Electronystagmograph into India, an MD15 import license from the Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and involves:

1. Document Preparation: Compile 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: Apply using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to department queries.
4. License Grant: CDSCO grants the MD15 license.

Import License Documents Required

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

Timeline and Processing Duration for Electronystagmograph License

Government Fees and Costs

• MD5 License: Rs. 5,000 per application plus Rs. 500 per product
• MD15 Import License:
  • Class B: Approximately $2000 per site plus$1000 per product

Additional costs include testing fees at government-approved labs and notified body audit charges.

Common Challenges and Solutions

• Delayed Testing Results: Plan testing well in advance and select CDSCO-approved labs (Testing Laboratories) to avoid bottlenecks.
• Incomplete Documentation: Use comprehensive checklists and refer to our Device Master File Guide to ensure completeness.
• Audit Non-Compliance: Pre-audit your facility using notified bodies listed at Notified Bodies List.
• Query Response Delays: Assign dedicated personnel for prompt communication with CDSCO.

Expert Consultation and Support

With our extensive experience supporting over 500 medical device companies, we offer tailored assistance in:

• Preparing and reviewing application documents
• Coordinating with notified bodies and testing labs
• Navigating regulatory queries efficiently
• Ensuring compliance with QMS and risk management requirements

Our goal is to minimize your time to market and ensure regulatory compliance without surprises.

Getting Started with Your CDSCO License Application for Electronystagmograph

1. Assess your product classification and intended market (manufacture or import).
2. Establish your technical and quality documentation, focusing on DMF and PMF.
3. Apply for the Test License (Form MD13) if manufacturing locally.
4. Schedule product testing at CDSCO-approved labs early.
5. Submit your application through the CDSCO MD Online Portal.
6. Prepare for and coordinate the audit with a notified body.
7. Respond promptly to any CDSCO queries.

For a smooth regulatory journey, leverage expert consultation to avoid common pitfalls and expedite your Electronystagmograph’s entry into the Indian market.

Contact us today to begin your CDSCO licensing process with confidence.