CDSCO License for Flexible fibreoptic oesophagoscope

Introduction to Flexible Fibreoptic Oesophagoscope and Its Regulatory Importance

Flexible fibreoptic oesophagoscopes are essential gastroenterology devices designed for the visual examination and treatment of the oesophagus. Given their critical role in diagnostics and therapeutic interventions, ensuring their compliance with India's regulatory framework is paramount for manufacturers and importers aiming to enter the Indian market safely and legally. With over 25 years of experience assisting 500+ companies, we understand the nuances of obtaining the necessary CDSCO licenses for such Class B medical devices.

CDSCO Regulatory Framework for Flexible Fibreoptic Oesophagoscopes

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. As per the notification 29/Misc./03/2020-DC (182) dated 27.09.2021, flexible fibreoptic oesophagoscopes fall under the gastroenterology category and are classified as Class B devices due to their moderate risk profile. This classification mandates obtaining an MD5 manufacturing license for domestic production or an MD15 import license for foreign manufacturers seeking market entry.

Risk Classification and License Requirements for Class B Devices

Class B devices involve a moderate risk level, necessitating careful regulatory scrutiny. The MD5 license, granted by the State Licensing Authority, is the prescribed pathway for manufacturing Class B devices like flexible fibreoptic oesophagoscopes. This process includes obtaining a test license (Form MD13), product testing, audit by a notified body, and final license issuance.

For importers, the MD15 import license granted by the Central Licensing Authority is required, involving compliance with documentation and certification standards.

Manufacturing License Process (MD5) for Flexible Fibreoptic Oesophagoscopes

The MD5 license process for Class B devices typically spans 3-4 months and involves several key steps:

1. Test License Application (Form MD13): Initiate by applying for a test license, which takes approximately 1.5-2 months. This license permits product testing in government-approved laboratories.

2. Product Testing: Conduct comprehensive testing at laboratories accredited by CDSCO to verify safety and performance. See the list of testing laboratories for approved centers.

3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Apply for the manufacturing license using Form MD3 on the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an audit conducted by a notified body to assess compliance with regulatory standards. The list of notified bodies can guide your selection.

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

7. License Grant: Upon successful audit and query resolution, the MD5 license is granted, enabling legal manufacture.

Manufacturing License Documents Required

For flexible fibreoptic oesophagoscopes, the following documents are essential:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Records
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing, and performance characteristics (Device Master File Guide)
• Plant Master File describing manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
• Risk Management File per ISO 14971 standards (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Flexible Fibreoptic Oesophagoscopes

For importers, obtaining an MD15 license involves:

1. Document Compilation: Gather all relevant manufacturing and compliance documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and Wholesale Drug License in India.

2. Application Submission: Submit the application in Form MD14 on the CDSCO MD Online Portal.

3. Departmental Review: Respond to departmental queries diligently during the 5-6 month review period.

4. License Issuance: Upon satisfactory evaluation, the MD15 import license is granted, enabling product importation into India.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License in India
• Company Incorporation Documents

Timeline and Processing Duration

Manufacturers should allocate sufficient time for testing and audit scheduling, as these steps are often the most time-consuming.

Government Fees and Costs

• MD5 License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 License (Import):

  • Class B Device Fee: ₹2,000 per site
  • Per Product Fee: ₹1,000

Additional costs include fees for notified body audits, testing laboratory charges, and consultant fees if applicable.

Common Challenges and Solutions

• Delayed Test License Approval: Ensure all test license documents are complete and accurate. Engage with testing labs early to schedule tests.

• Non-Compliance in Audits: Prepare thoroughly by conducting internal audits and gap analyses before notified body visits.

• Document Gaps: Utilize expert guidance and templates for Device and Plant Master Files to avoid rejections.

• Query Resolution Delays: Respond promptly and comprehensively to departmental queries.

Expert Consultation and Support

With our extensive experience supporting over 500 manufacturers and importers, we offer tailored consulting services that streamline the CDSCO licensing process. From document preparation to audit readiness and query management, our expert team ensures your flexible fibreoptic oesophagoscope attains timely market authorization.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class B status for your flexible fibreoptic oesophagoscope using the Medical Device Classification resource.

2. Plan Testing and Documentation: Initiate the test license application (Form MD13) via the CDSCO MD Online Portal, and begin compiling your Device and Plant Master Files.

3. Engage a Notified Body: Select a notified body from the official list and schedule your audit.

4. Prepare for Audit: Conduct internal audits and finalize your Quality Management System documentation.

5. Submit MD5 Application: Once testing and audit steps are complete, apply for the MD5 license through the CDSCO portal.

By following these actionable steps and leveraging expert advice, manufacturers can confidently navigate the regulatory landscape, ensuring their flexible fibreoptic oesophagoscopes reach Indian healthcare providers efficiently and compliantly.