CDSCO License for Intranasal lacrimal neurostimulator

Introduction to Intranasal Lacrimal Neurostimulator and Regulatory Importance

The Intranasal Lacrimal Neurostimulator is an innovative, hand-held ophthalmic device designed to electrically stimulate sensory neurons within the nasal cavities. Its primary purpose is to enhance tear production to treat aqueous deficient dry eye syndrome, enabling patients to manage symptoms conveniently at home. Given its novel mechanism and direct therapeutic impact, this device is classified as a Class C medical device under the Indian regulatory framework.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing for such devices is crucial to legally manufacture or import and market them in India. Compliance ensures patient safety, product efficacy, and smooth market entry, avoiding costly delays or enforcement actions.

CDSCO Regulatory Framework for Intranasal Lacrimal Neurostimulator

India's medical device regulation falls under the Drugs and Cosmetics Act, 1940, with CDSCO as the central authority overseeing licensing. Since August 2020, medical devices like the Intranasal Lacrimal Neurostimulator require mandatory registration and licensing before commercialization.

This device categorizes under Class C (moderate to high risk), as per the device notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, making it subject to stringent regulatory scrutiny via the MD9 manufacturing license route.

Risk Classification and License Requirements

The Intranasal Lacrimal Neurostimulator falls under Class C due to its invasive use and therapeutic impact on sensitive ocular tissues. Class C devices require obtaining an MD9 manufacturing license from CDSCO’s Central Licensing Authority.

For manufacturers, this means:

• Obtaining a Test License (Form MD13) initially
• Product testing in government-approved laboratories
• Document submission and audit by CDSCO inspectors
• Resolution of queries and compliance checks

Importers must secure an MD15 Import License but in most cases, manufacturers need to first obtain MD9.

For more on device classification, you can refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD9) for Intranasal Lacrimal Neurostimulator

The MD9 license application process is comprehensive, typically spanning 4-5 months from start to finish:

1. Apply for a Test License (Form MD13): This preliminary license allows sample testing and takes about 1.5-2 months to be granted.
2. Product Testing: Testing must be conducted at CDSCO-recognized laboratories to validate safety and efficacy. See the list of testing laboratories for approved options.
3. Document Preparation: Prepare a full dossier including technical, quality, and safety documentation.
4. File the MD9 Application (Form MD7) via the CDSCO MD Online Portal.
5. CDSCO Inspection and Audit: Inspectors will audit your manufacturing facility and documentation.
6. Respond to Queries: Address any observations or clarifications raised by the inspectors.
7. Grant of MD9 License (Form MD9): Upon satisfactory compliance, the license is issued.

Manufacturing License Documents Required for MD9

The documentation package is critical and must be meticulously prepared. Key documents include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device design, specifications, and manufacturing processes. Our Device Master File guide offers in-depth insights.
• Plant Master File (PMF): Facility layout, equipment, and quality management systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Compliance with Indian medical device standards.
• Risk Management File: Comprehensive risk assessment and mitigation strategies aligning with ISO 14971. See our Risk Management guide.
• Test Reports from approved labs
• Product Labels and Instructions For Use (IFU)
• Quality Management System (QMS) Documents, generally ISO 13485:2016 certification

Thorough document preparation helps avoid delays during audit and review.

Import License Process (MD15) for Intranasal Lacrimal Neurostimulator

For importers of this Class C device, the MD15 license is mandatory and granted by the CDSCO Central Licensing Authority. The process typically takes 5-6 months.

Steps include:

1. Document Preparation, including:
   • Valid Manufacturing License (MD9) from the country of origin
   • Free Sale Certificate
   • ISO 13485:2016 certification
   • CE Certificate (if applicable)
   • Device Master File and Plant Master File
   • Wholesale License
   • Company Constitution
2. Application Submission on the CDSCO MD Online Portal
3. Clarifications and Queries Handling by CDSCO
4. Grant of MD15 Import License

Timeline and Processing Duration

Import license (MD15) typically requires 5-6 months.

Government Fees and Costs

For Class C devices like the Intranasal Lacrimal Neurostimulator, fees are as follows:

MD9 Manufacturing License Fees

• Application Fee: ₹50,000
• Per Product Fee: ₹1,000

MD15 Import License Fees

• Site Fee: $3,000 (approx ₹2,50,000)
• Per Product Fee: $1,500 (approx ₹1,25,000)

Additional costs include laboratory testing fees and audit-related expenses.

Common Challenges and Solutions

Challenge 1: Delays in Test License and Product Testing

• Solution: Pre-prepare all technical files to avoid repeated submissions. Select testing labs early from the CDSCO-approved list.

Challenge 2: Incomplete Documentation Leading to Audit Queries

• Solution: Use comprehensive checklists and templates for DMF and PMF. Leverage expert consultancy to ensure compliance.

Challenge 3: Quality Management System Gaps

• Solution: Implement ISO 13485:2016 rigorously, conduct internal audits, and maintain robust CAPA systems.

Challenge 4: Misunderstanding Classification or Licensing Pathway

• Solution: Confirm classification with CDSCO notifications and expert guidance to avoid incorrect applications and rework.

Expert Consultation and Support

With over 25 years of experience facilitating CDSCO licensing for 500+ companies, we specialize in:

• Tailored regulatory strategy development for ophthalmic devices
• End-to-end documentation support including Device and Plant Master Files
• Liaising with CDSCO and notified bodies for audits
• Preparing responses to technical queries

Our proven approach minimizes time-to-market and maximizes compliance confidence.

Getting Started with Your CDSCO License Application for Intranasal Lacrimal Neurostimulator

1. Assess your device classification and confirm license type (MD9 for manufacturing).
2. Register on the CDSCO MD Online Portal to initiate your application.
3. Compile your technical documentation bundle, focusing on Device and Plant Master Files, Risk Management, and Test Reports.
4. Apply for Test License (MD13) and schedule product testing at an approved laboratory.
5. Simultaneously, prepare your Quality Management System to meet ISO 13485:2016 standards.
6. Once test license and reports are ready, submit your MD9 application (Form MD7).
7. Prepare for the CDSCO inspection and audit by conducting internal mock audits.
8. Respond promptly to any queries raised during the review process.

Following these actionable steps will set a strong foundation for your successful CDSCO licensing journey.

For detailed consulting or assistance with your Intranasal Lacrimal Neurostimulator CDSCO application, contact our regulatory experts today.