CDSCO License for Pharyngeal electrical stimulation catheter

Introduction to Pharyngeal Electrical Stimulation Catheter and Regulatory Importance

A Pharyngeal Electrical Stimulation Catheter is a specialized, sterile, flexible tubular device designed to deliver targeted electrical stimulation to the pharynx, primarily used in treating neurogenic dysphagia. Given its critical role in gastroenterology and patient safety, this device falls under Class C risk according to the Central Drugs Standard Control Organization (CDSCO) classification, necessitating stringent regulatory oversight.

Navigating the CDSCO regulatory framework is essential for manufacturers and importers aiming to launch this device in India. Compliance ensures market access, patient safety, and adherence to Indian medical device regulations.

CDSCO Regulatory Framework for Class C Medical Devices

The CDSCO governs medical device regulation in India under the Ministry of Health and Family Welfare. Devices are classified from Class A (low risk) to Class D (high risk), with Class C devices like the Pharyngeal Electrical Stimulation Catheter requiring a central license known as the MD9 license.

Regulatory submission encompasses documentation, testing, audits, and compliance with essential principles stipulated by CDSCO. The notification number 29/Misc./03/2020-DC (182), dated 27.09.2021, specifically includes your device category, affirming its regulatory pathway.

Risk Classification and License Requirements

The Pharyngeal Electrical Stimulation Catheter is classified as a Class C device due to its invasive nature and potential impact on critical body systems. For Class C devices, CDSCO mandates the following:

• Licensing Authority: Central Licensing Authority
• License Type: MD9 (Manufacturing License for Class C and D devices)
• Application Form: MD7
• Test License Required: Yes (Form MD13)

Manufacturing License Process (MD9)

Obtaining the MD9 manufacturing license involves a multi-step process:

1. Test License Application (Form MD13): Initially, apply for a test license valid typically for 6 months. This allows manufacturing of limited batches for testing.
2. Product Testing: Submit samples to government-approved testing laboratories for compliance verification.
3. Document Preparation: Compile comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) documentation.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO inspectors will audit your manufacturing facility and documentation.
6. Query Resolution: Address any queries raised during the audit or document review.
7. License Grant: Upon satisfactory compliance, the MD9 license is granted.

Manufacturing License Documents Required

For Class C devices like the Pharyngeal Electrical Stimulation Catheter, the following documents are mandatory:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification Certificates
• Fire and Pollution NOC (No Objection Certificates)
• Device Master File (DMF) detailing device specifications, design, and manufacturing process (see our comprehensive Device Master File guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (reference our Plant Master File guide)
• Essential Principles Checklist ensuring compliance with Indian medical device rules
• Risk Management File following ISO 14971 standards (learn more about Risk Management)
• Product Test Reports from CDSCO-approved laboratories (see Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certification

Import License Process (MD15)

If you are an importer rather than a manufacturer, the import license MD15 is required. This process involves:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and wholesale license
• Application through the CDSCO MD Online Portal
• Queries resolution with CDSCO as needed
• License grant typically within 5-6 months

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license or equivalent
• Company Incorporation Documents

Timeline and Processing Duration

The overall timeline for obtaining an MD9 license for Class C devices such as the Pharyngeal Electrical Stimulation Catheter is approximately 4-5 months. Breakdown:

• Test License (MD13) issuance: 1.5-2 months
• Product Testing: 1-1.5 months (can run concurrently with document prep)
• Document preparation and submission: 2-3 weeks
• Audit and inspection: 1 month
• Query resolution and final approval: 2-4 weeks

For import licenses (MD15), expect a timeline of 5-6 months due to additional document verification.

Government Fees and Costs

Fees for Class C device licensing are as follows:

• MD9 Manufacturing License:

  • Application Fee: Rs. 50,000 per application
  • Per Product Fee: Rs. 1,000 per product

• Test License (MD13): Typically included within the licensing fees but subject to specific state notifications.

• Import License (MD15):

  • Site Fee: $3,000 USD per site
  • Product Fee: $1,500 USD per product

Additional costs include laboratory testing fees, notified body audit charges, and consultancy fees if applicable.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or incomplete DMF or PMF. Proactive preparation using detailed checklists mitigates this.

• Delayed Testing: Testing labs may have backlogs. Early sample submission and selection of CDSCO-recognized labs, as listed on the Testing Laboratories page, help prevent bottlenecks.

• Audit Non-Compliance: Ensure your manufacturing site strictly follows QMS and CDSCO guidelines. Pre-audit internal checks can improve outcomes.

• Query Resolution Delays: Respond promptly and comprehensively to queries from CDSCO to avoid extended processing times.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we understand the nuances of Class C device registrations. Our expert team can help:

• Prepare and review Device Master Files and Plant Master Files
• Guide through the test license and product testing phases
• Coordinate with notified bodies and CDSCO inspectors
• Provide end-to-end application submission and follow-up support

For detailed guidance, refer to our dedicated MD9 License Guide.

Getting Started with Your CDSCO License Application

To initiate your licensing journey for the Pharyngeal Electrical Stimulation Catheter, follow these practical steps:

1. Review Classification and Requirements: Confirm your device's Class C classification and familiarize yourself with the MD9 license process.
2. Prepare Documentation: Begin compiling all necessary documents including DMF, PMF, and risk management files.
3. Apply for Test License (MD13): Submit your application on the CDSCO MD Online Portal to manufacture samples for testing.
4. Coordinate Product Testing: Engage with CDSCO-approved laboratories early to schedule testing.
5. Schedule Internal Audits: Prepare your manufacturing site and QMS for the upcoming CDSCO inspection.
6. Submit MD9 Application: After successful testing and documentation readiness, apply for the manufacturing license.
7. Track and Respond: Monitor your application status and respond promptly to any CDSCO queries.

Starting early and maintaining clear communication with regulatory authorities significantly increases your chances of timely approval. For personalized assistance, connect with our regulatory experts today.