CDSCO License for Facial nerve  locating system

Comprehensive Guide to CDSCO Licensing for Facial Nerve Locating System (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 companies through the intricate process of obtaining CDSCO licenses in India. This guide focuses on the Facial Nerve Locating System, a Class B neurological medical device designed to locate the facial nerve by applying electrical stimuli, notified under 29/Misc/03/2020-DC (201) dated 27.09.2021. If you are a manufacturer or importer aiming to enter the Indian market with this device, understanding the regulatory landscape and licensing requirements is crucial.

CDSCO Regulatory Framework for Facial Nerve Locating System

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Facial Nerve Locating System falls under the neurological device category and is classified as a Class B device due to its moderate risk profile. This classification requires a manufacturing license (MD5) granted by the State Licensing Authority. Importers will need an import license (MD15) from the Central Licensing Authority.

Risk Classification and License Requirements

According to CDSCO’s risk-based approach:

• Class A & B devices (low to moderate risk) require an MD5 Manufacturing License (Application Form MD3).
• Class C & D devices (higher risk) require MD9 license issued by the Central Licensing Authority.

For the Facial Nerve Locating System (Class B), the MD5 license process applies, involving a test license (MD13), product testing, audit, and final license grant.

Manufacturing License Process (MD5)

The MD5 license process spans approximately 3 to 4 months and comprises the following steps:

1. Test License Application (Form MD13): Obtain a test license to manufacture the device for testing purposes. This takes about 1.5 to 2 months.
2. Product Testing: Conduct testing of the device in CDSCO-approved labs for compliance with applicable standards.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit: An audit by a Notified Body is carried out to verify compliance.
6. Query Resolution: Address any queries raised by the department or notified body promptly.
7. License Grant: Upon successful review and audit, the MD5 license is granted.

Manufacturing License Documents Required

Your application should include the following key documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire NOC and Pollution Control Certificate
• Device Master File (DMF) – detailing the design, materials, and specifications (Device Master File Guide)
• Plant Master File (PMF) – outlining manufacturing processes and quality controls (Plant Master File Guide)
• Essential Principles Checklist – conformity with Indian regulations
• Risk Management File – documenting risk analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved testing laboratories (Testing Laboratories List)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485 certifications

Import License Process (MD15)

If you plan to import the Facial Nerve Locating System into India, an import license (MD15) from the Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and includes:

• Preparation of required documents such as Free Sale Certificate, ISO 13485:2016, CE Certificate, Manufacturing License from the country of origin
• Submission of application using Form MD14 on the CDSCO MD Online Portal
• Resolution of any queries raised by the regulatory authority
• License issuance upon successful review

Import License Documents Required

Key documents include:

• Valid Manufacturing License of the product
• Free Sale Certificate from country of origin
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale license (if applicable)
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

Government Fees and Costs

For the Facial Nerve Locating System (Class B):

• MD5 Manufacturing License:
  • Application Fee: ₹5,000
  • Fee per product: ₹500
• Test License (MD13): Fees as per state authority norms

For imported devices (MD15 license), fees vary by risk class and product quantity. For Class B devices, expect fees around:

• ₹2,000 per site
• ₹1,000 per product

Common Challenges and Solutions

Challenge 1: Document Completeness and Accuracy

• Solution: Use detailed checklists and templates for Device and Plant Master Files. Our Device Master File guide and Plant Master File guide simplify this process.

Challenge 2: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing laboratories early. Plan the test license and testing phase carefully to avoid bottlenecks.

Challenge 3: Audit Readiness

• Solution: Conduct internal audits and pre-audit assessments before the notified body visit. Ensure QMS compliance and staff preparedness.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with clear, evidence-backed replies. Maintain open communication lines with CDSCO officials.

Expert Consultation and Support

Navigating the CDSCO licensing landscape requires expertise and strategic planning. We provide comprehensive consultancy services including document preparation, regulatory strategy, audit facilitation, and query management tailored for neurological devices like the Facial Nerve Locating System. Our proven track record with over 500 successful approvals ensures a smoother, faster journey to market.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm the Class B status and intended use.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Schedule product testing with CDSCO-approved labs.
4. Compile Documentation: Leverage our expert guides to prepare your Device Master File, Plant Master File, Risk Management File, and other mandatory documents.
5. Submit Manufacturing License Application: File Form MD3 for the MD5 license on the MD Online Portal.
6. Prepare for Audit: Coordinate with a notified body from the Notified Bodies List for your compliance audit.
7. Track Application Progress: Stay proactive in responding to queries to avoid delays.

By following these actionable steps with expert support, you can confidently navigate the regulatory process and bring your Facial Nerve Locating System to the Indian market efficiently and compliantly.

For personalized assistance or to start your application process, contact us today and leverage our 25+ years of CDSCO licensing expertise.