CDSCO License for Nasopharyngeal electrode.
Medical Device Information
Intended Use
A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity
Comprehensive CDSCO Licensing Guide for Nasopharyngeal Electrodes (Class C Medical Device)
Nasopharyngeal electrodes play a crucial role in neurological diagnostics by recording electrical activity from the nasopharyngeal region. As a Class C device under the Indian regulatory framework, obtaining a CDSCO license is mandatory before manufacturing or importing this device into India. With over 25 years of experience and having supported 500+ companies in navigating CDSCO regulations, we provide you a detailed roadmap to secure your MD9 manufacturing or import license efficiently.
CDSCO Regulatory Framework for Nasopharyngeal Electrodes
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Ministry of Health and Family Welfare, Government of India. Nasopharyngeal electrodes fall into the Class C risk category due to their invasive nature and neurological application. The relevant notification for this device is 29/Misc/03/2020-DC (201), dated 27.09.2021.
Manufacturers and importers must comply with the Medical Device Rules, 2017, which outline the approval process, documentation, and quality standards.
Risk Classification and License Requirements
Class C devices are considered moderate to high risk and require a license from the Central Licensing Authority. The applicable license for manufacturing is the MD9 license, and for import, the MD15 license is mandatory.
| Device Type | Risk Class | License Type | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Nasopharyngeal Electrode | C | MD9 | Central Licensing Authority | 4-5 months (manufacturing) | Rs 50,000 + Rs 1,000 per product |
| Nasopharyngeal Electrode | C | MD15 | Central Licensing Authority | 5-6 months (import) | Rs 3,000 per site + Rs 1,500 per product |
For detailed device classification, you can visit our Medical Device Classification guide.
Manufacturing License Process (MD9 License)
Securing an MD9 license requires a multi-step process:
- Test License (MD13): Initially, apply for a test license, which takes approximately 1.5 to 2 months. This allows you to manufacture the device for testing purposes.
- Testing: Get your nasopharyngeal electrode tested at a CDSCO-approved laboratory. Check the list of Testing Laboratories for government-approved facilities.
- Documentation Preparation: Prepare all required documents, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.
- Application Submission: File the MD9 application (Form MD7) on the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO officials conduct an inspection of your manufacturing site and review all documentation.
- Query Resolution: Address any queries or deficiencies raised by CDSCO during the review.
- License Grant: Once all requirements are met, the MD9 license is granted (Form MD9).
For a detailed stepwise guide, refer to our MD9 License Guide.
Manufacturing License Documents Required for Nasopharyngeal Electrodes
Ensure you have the following documentation in place to avoid delays:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership / Lease Agreement for Manufacturing Premises
- Details and Qualifications of Technical Personnel
- Fire No Objection Certificate (NOC)
- Pollution NOC (if applicable)
- Device Master File (DMF): Comprehensive technical file including design, manufacturing process, and validation. Our Device Master File guide provides practical insights.
- Plant Master File (PMF): Details about manufacturing facilities and quality systems. Learn how to create one in our Plant Master File guide.
- Essential Principles Checklist
- Risk Management File (per ISO 14971). See our Risk Management guide for best practices.
- Test Reports from CDSCO-approved labs
- Labels, Instructions for Use (IFU)
- Quality Management System (QMS) documents (preferably ISO 13485:2016 certified)
Import License Process (MD15 License)
If you plan to import nasopharyngeal electrodes, follow these steps:
- Document Preparation: Compile all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 Certificate, CE Certificate, Device Master File, and Plant Master File.
- Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
- Review and Query Resolution: CDSCO reviews your application and may raise queries.
- License Grant: Upon satisfactory compliance, the MD15 import license is issued.
For a comprehensive breakdown, visit our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
- Proof of Ownership or Lease of premises
Timeline and Processing Duration
| License Type | Step | Duration |
|---|---|---|
| Test License (MD13) | Application to grant | 1.5 to 2 months |
| Product Testing | Testing by CDSCO-approved lab | 1 to 1.5 months |
| MD9 License Application | Documentation & audit | 2 to 3 months |
| Total Manufacturing License | 4 to 5 months | |
| MD15 Import License | Application to grant | 5 to 6 months |
Timelines may vary depending on the completeness of submissions and response time to CDSCO queries.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | Rs 50,000 | Rs 1,000 |
| MD15 Import | Rs 3,000 per site | Rs 1,500 |
Additional costs include testing fees at approved labs (typically Rs 50,000 to Rs 1,00,000 depending on the tests) and professional consultancy fees if availed.
Common Challenges and Solutions
- Incomplete Documentation: Missing technical files or certificates often delay processing. Use detailed checklists to ensure completeness.
- Testing Delays: Testing labs may have backlogs; plan testing early and confirm lab availability.
- Audit Readiness: Non-compliance in QMS or plant conditions can result in audit failures. Conduct internal audits beforehand.
- Query Management: Delayed response to CDSCO queries stalls approval. Maintain a dedicated regulatory team for prompt communication.
Our experience shows that proactive preparation and expert guidance significantly reduce approval time.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like nasopharyngeal electrodes can be complex. Our expert team offers:
- End-to-end license application management
- Document preparation and review
- Liaison with CDSCO officials and notified bodies
- Training on regulatory compliance and audit preparedness
Leverage our 25+ years of proven expertise to streamline your regulatory journey.
Getting Started with Your CDSCO License Application
- Assess your device classification confirming Class C status.
- Initiate a test license (MD13) application on the CDSCO MD Online Portal.
- Identify and engage a CDSCO-approved testing laboratory early to schedule your product testing.
- Begin compiling essential documents including Device and Plant Master Files, risk management files, and quality system records.
- Plan for audit readiness by reviewing your manufacturing site and quality processes.
- Submit the MD9 license application (Form MD7) once testing is complete and documentation is ready.
For detailed assistance, consult our MD9 License Guide and connect with regulatory experts.
Taking these practical steps early ensures a smoother approval path, enabling timely market entry for your nasopharyngeal electrode in India.
