CDSCO License for Flexible fibreoptic gastroscope

Comprehensive Guide to CDSCO Licensing for Flexible Fibreoptic Gastroscope (Class B)

As a trusted regulatory consulting firm with over 25 years of experience and having assisted 500+ companies in navigating the complex CDSCO licensing landscape, we provide you with an authoritative, step-by-step guide on obtaining your CDSCO license for manufacturing the Flexible Fibreoptic Gastroscope in India. This device, categorized under gastroenterology with risk class B, requires careful attention to regulatory compliance for smooth market access.

Introduction: Understanding the Flexible Fibreoptic Gastroscope and Its Regulatory Significance

The Flexible Fibreoptic Gastroscope is an advanced endoscopic device featuring a flexible inserted portion designed for the visual examination and treatment of the oesophagus and stomach. Its minimally invasive nature and diagnostic capabilities make it crucial in gastroenterology.

Given its medical importance and moderate risk classification (Class B), regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures device safety, effectiveness, and quality. Complying with CDSCO regulations is mandatory for both manufacturers and importers aiming to operate legally in India.

CDSCO Regulatory Framework for Flexible Fibreoptic Gastroscope

The CDSCO follows a structured regulatory framework based on the Medical Device Rules (MDR) 2017, which classifies devices into four risk categories: A, B, C, and D. For Class B devices like the Flexible Fibreoptic Gastroscope, the regulatory authority is the State Licensing Authority, and the appropriate manufacturing license is the MD5 license.

The device is notified under the Gazette Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, which confirms its classification and regulatory requirements.

Risk Classification and License Requirements for Class B Devices

Flexible Fibreoptic Gastroscopes fall under Class B (low moderate risk). This classification dictates the licensing approach:

• Manufacturing License: MD5 (Application Form MD3)
• Licensing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months
• Fees: Rs 5,000 per application plus Rs 500 per product

Manufacturers must secure a Test License (Form MD13) before applying for the manufacturing license.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 license process includes the following key steps:

1. Test License Application (Form MD13): Obtain a Test License which allows you to manufacture the device for testing purposes. This usually takes 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-recognized laboratories to fulfill quality and safety benchmarks. Refer to the official list of testing laboratories.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. MD5 License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit will be conducted by a notified body to verify compliance. Check the list of notified bodies for your region.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly to avoid delays.

7. Grant of License (Form MD5): Upon successful audit and query resolution, the license is granted.

For detailed guidance on the MD5 license process, you can refer to our comprehensive MD5 License Guide.

Manufacturing License Documents Required for Flexible Fibreoptic Gastroscope

Accurate and complete documentation is critical. The following are mandatory:

• Company Constitution Documents: Articles of incorporation, partnership deed, or equivalent
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualifications and experience of competent personnel
• Fire NOC and Pollution Control NOC
• Device Master File: Detailed device description, design, manufacturing process (see our Device Master File guide)
• Plant Master File: Manufacturing facilities details (Plant Master File Guide)
• Essential Principles Checklist: Compliance checklist as per MDR 2017
• Risk Management File: Demonstrating risk analysis and mitigation (Risk Management Guide)
• Test Reports: From CDSCO-recognized labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: Typically ISO 13485 certification and SOPs

Import License Process for Flexible Fibreoptic Gastroscope (MD15 License)

For importers, an MD15 license is mandatory. The process is governed by the Central Licensing Authority and generally takes 5-6 months.

Key steps include:

1. Document Compilation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond to department queries efficiently.

4. Grant of Import License (Form MD15): Upon satisfaction, the license is issued.

The government fees vary by device class and site, with Class B devices incurring Rs 1,50,000 per site and Rs 1,00,000 per product approximately.

For an in-depth understanding, visit our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• MD5 License Application and Audit: 1 to 1.5 months
• Total Duration: Approximately 3 to 4 months

Government Fees and Costs

• MD5 Manufacturing License Application: Rs 5,000
• Per Product Fee: Rs 500
• Testing Costs: Variable; depends on the number of tests and labs
• Audit Fees: Payable to notified bodies; varies depending on scope

Budgeting realistically for approximately Rs 1-2 lakhs for the entire process is prudent.

Common Challenges and Practical Solutions

• Documentation Gaps: Incomplete or inconsistent Device Master File or Risk Management File often causes delays. We recommend early preparation and expert review.

• Testing Delays: Selecting CDSCO-approved laboratories well in advance and scheduling tests promptly helps avoid bottlenecks.

• Audit Non-conformities: Ensuring QMS compliance and staff readiness reduces audit observations.

• Query Response Delays: Assigning dedicated personnel to monitor and respond to CDSCO queries expedites approvals.

Expert Consultation and Support

Having supported over 500 clients, we understand the nuances of CDSCO licensing for Class B devices like the Flexible Fibreoptic Gastroscope. Our tailored consulting services cover:

• End-to-end application drafting
• Documentation audits
• Coordination with notified bodies and testing labs
• Training for compliance and audit preparedness

Contact us early to mitigate risks and streamline your regulatory journey.

Getting Started with Your CDSCO License Application

1. Assess Your Readiness: Compile your company’s technical and legal documents.

2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.

3. Plan Product Testing: Identify and book slots with CDSCO-recognized testing laboratories.

4. Prepare Comprehensive Documentation: Leverage our Device and Plant Master File guides to ensure compliance.

5. Engage a Notified Body Early: Schedule your mandatory audit.

6. Submit Manufacturing License Application (Form MD3): Upon successful testing and documentation.

7. Stay Proactive: Monitor application status and respond to queries promptly.

Embarking on this process with a clear roadmap and expert guidance significantly enhances your chances of timely license approval, enabling your Flexible Fibreoptic Gastroscope to reach patients across India safely and compliantly.