CDSCO License for Esophageal obturator

Comprehensive Guide to CDSCO Licensing for Esophageal Obturator Devices (Class B Catheters)

As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 companies, we understand the nuances of obtaining CDSCO licenses for medical devices like the Esophageal Obturator. This device, classified as a Class B catheter under the CDSCO framework, plays a critical role in emergency resuscitation by occluding the esophagus to facilitate positive pressure ventilation through the trachea.

Navigating the regulatory landscape for such a device is essential for manufacturers and importers aiming to enter the Indian market compliantly and efficiently. In this guide, we provide detailed insights into the regulatory framework, licensing procedures, timelines, costs, and documentation specific to the Esophageal Obturator.

CDSCO Regulatory Framework for Esophageal Obturator (Class B Catheter)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Esophageal Obturator falls under the "Catheters" category and is notified under the reference 29/Misc/3/2017-DC (292), dated 06.06.2018.

Classified as a Class B device, it is considered low moderate risk and requires a manufacturing license (MD5) issued by the State Licensing Authority. Importers must obtain the MD15 import license from the Central Licensing Authority.

Understanding this regulatory framework is pivotal to ensuring timely approvals and market entry.

Risk Classification and License Requirements

• Risk Class: B (Low Moderate Risk)
• License for Manufacturing: MD5 License (Application Form MD3)
• License for Import: MD15 License (Application Form MD14)
• Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import

For Class B devices like the Esophageal Obturator, the MD5 manufacturing license process includes a mandatory test license (MD13), product testing, document submission, and audit by a notified body.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license is the cornerstone for legally manufacturing the Esophageal Obturator in India. Here's a step-by-step overview:

1. Obtain Test License (Form MD13): The process begins with applying for a test license, which takes approximately 1.5 to 2 months. This license allows you to carry out product testing legally.

2. Product Testing: Submit your Esophageal Obturator samples to government-approved testing laboratories to verify compliance with applicable standards. You can find the list of approved testing laboratories here.

3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), 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: An audit is conducted by a notified body from the official list of notified bodies to verify compliance with manufacturing and quality standards.

6. Query Resolution: Address any queries raised by the CDSCO or notified body promptly.

7. Grant of License: Once all requirements are met, the MD5 license is granted on Form MD5, allowing you to manufacture the device legally.

Overall, this entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for Esophageal Obturator

For a smooth application, ensure you have the following documents ready:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Comprehensive Device Master File (DMF) detailing design, specifications, and performance data. Refer to our Device Master File guide for best practices.
• Plant Master File (PMF) outlining manufacturing facilities and processes. Learn more at our Plant Master File guide.
• Essential Principles Checklist confirming compliance with regulatory requirements
• Risk Management File demonstrating risk analysis and mitigation strategies. Check our Risk Management resource for implementation tips.
• Product Test Reports from accredited laboratories
• Labels and Instructions for Use (IFU) complying with CDSCO standards
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Esophageal Obturator

If you intend to import the Esophageal Obturator into India, you must obtain an MD15 import license from the Central Licensing Authority. The process is as follows:

1. Document Preparation: Gather all required documents, including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.

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

3. Review and Queries: The CDSCO reviews the application and may raise queries.

4. Grant of Import License: Upon satisfactory review, the MD15 license is issued.

The import license process generally takes 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License issued by the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale License for distribution in India
• Company Constitution and registration documents

Timeline and Processing Duration

Being proactive in document preparation and responding promptly to queries can significantly reduce timelines.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: Rs 5,000 per application
  • Product Fee: Rs 500 per product

• Test License (MD13): Included within the MD5 process

• MD15 Import License:

  • Site Fee: $1,000 per site (Class B device)
  • Product Fee: $1,000 per product

Planning your budget to accommodate these fees and ancillary costs like laboratory testing and audits is critical for smooth regulatory compliance.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs.

Solution: Engage with multiple government-approved labs early and confirm testing schedules to avoid bottlenecks.

Challenge: Incomplete or non-compliant documentation causing audit failures.

Solution: Utilize our comprehensive checklists and expert reviews for Device Master File and Plant Master File preparation.

Challenge: Unclear responses to CDSCO queries leading to prolonged review times.

Solution: Provide clear, evidence-backed responses and maintain open communication channels with the regulatory authority.

Expert Consultation and Support

With decades of experience guiding over 500 companies through CDSCO licensing, we offer tailored consulting services including:

• Detailed gap analysis of your current documentation
• End-to-end management of license applications via the CDSCO MD Online Portal
• Coordination with notified bodies and testing laboratories
• Training for your regulatory and quality teams on compliance best practices

Our expert support minimizes risks and accelerates your device’s market entry.

Getting Started with Your CDSCO License Application for Esophageal Obturator

1. Assess Your Device Classification: Confirm your device is Class B based on CDSCO’s medical device classification. Our Medical Device Classification resource can assist.

2. Compile Required Documentation: Begin assembling your Device Master File, Plant Master File, Risk Management File, and QMS documents.

3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal, enabling you to start product testing legally.

4. Engage Government-Approved Labs: Arrange for timely testing of your Esophageal Obturator samples.

5. Prepare for Audit: Coordinate with a notified body for the mandatory audit to ensure your manufacturing site and processes meet regulatory expectations.

6. Submit Manufacturing License Application (MD5): After fulfilling testing and audit requirements, apply for your manufacturing license.

7. Plan Import Licensing (if applicable): If importing, prepare documents and apply for the MD15 import license accordingly.

By following these actionable steps and leveraging our expert guidance, you can confidently navigate the CDSCO licensing process for your Esophageal Obturator device and successfully enter the Indian market.

For personalized assistance or to discuss your project in detail, feel free to contact our regulatory consulting team.