CDSCO License for Flexible video gastroscope

Introduction to Flexible Video Gastroscope and Regulatory Importance

The flexible video gastroscope is a critical medical device used extensively in gastroenterology for the visual examination and treatment of the oesophagus and stomach. As a Class B device under the Indian CDSCO regulatory framework, it demands rigorous compliance with safety, quality, and efficacy standards to ensure patient safety and successful market entry. Navigating the CDSCO licensing process can be complex, but with over 25 years of experience and helping 500+ companies, we provide you with precise, actionable guidance to secure your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Flexible Video Gastroscope

Classified as a Class B device, the flexible video gastroscope falls under medium-risk medical devices. The Central Drugs Standard Control Organization (CDSCO) regulates such devices to ensure adherence to the Medical Device Rules, 2017, and associated notifications, including Notification 29/Misc./03/2020-DC (182) dated 27.09.2021.

Manufacturers of Class B devices require a manufacturing license (MD5) issued by the State Licensing Authority, while importers must obtain an import license (MD15) from the Central Licensing Authority. Compliance includes design controls, product testing, quality management systems, risk management, and post-market surveillance.

Risk Classification and License Requirements for Flexible Video Gastroscope

The flexible video gastroscope is classified as a Class B medical device due to its invasive nature and medium potential risk. This classification mandates:

• Manufacturing License (MD5) for local manufacturers
• Import License (MD15) for importers

These licenses ensure that the device meets essential principles of safety and performance and complies with Indian regulations.

For detailed classification, you may refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Flexible Video Gastroscope

Obtaining an MD5 license for a Class B device involves a structured, multi-step process:

1. Test License Application (Form MD13): Initially, obtain a test license, which allows sample testing of your device. This typically takes 1.5-2 months.

2. Product Testing: Conduct product testing at CDSCO-approved laboratories to ensure compliance with Indian standards. Refer to the list of testing laboratories.

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

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

5. Audit by Notified Body: Undergo a mandatory audit by a notified body approved by CDSCO. You can check the list of notified bodies.

6. Queries and Clarifications: Respond promptly to any queries from the licensing authority or notified body.

7. Grant of License (Form MD5): Upon successful audit and document verification, the MD5 license is issued.

The entire process typically takes around 3-4 months from test license application to license grant.

Manufacturing License Documents Required for Flexible Video Gastroscope

Accurate and complete documentation is vital for expediting your MD5 license approval. Key documents include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. For guidance, see our Device Master File guide
• Plant Master File (PMF) describing manufacturing facilities, equipment, and quality systems. Learn how to create one at our Plant Master File guide
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and control measures (see Risk Management)
• Product Test Reports from CDSCO-recognized labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 compliant

Import License Process (MD15) for Flexible Video Gastroscope

Importers of flexible video gastroscopes must apply for the MD15 import license via the Central Licensing Authority. The key steps include:

1. Document Preparation: Compile mandatory documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.

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

3. Query Resolution: Address any clarifications or additional data requests promptly.

4. License Grant (Form MD15): Upon satisfaction, the import license is granted.

The MD15 license processing generally takes 5-6 months.

For a detailed overview, consult our Import License guide.

Import License Documents Required for Flexible Video Gastroscope

• Valid Manufacturing License from the Foreign Manufacturer
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable in India)
• Company Constitution and Address Proof

Timeline and Processing Duration

Understanding these timelines helps in effective project planning and market launch strategy.

Government Fees and Costs for Flexible Video Gastroscope Licensing

• MD5 License Fees:

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

• MD15 Import License Fees:

  • Site Fee: USD 1,000 (Class B device)
  • Per Product Fee: USD 1,000

Additional costs to consider include testing fees at CDSCO-approved labs and audit fees charged by notified bodies.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or improper device classification.

Solution: Engage experienced consultants to prepare and review documentation thoroughly. Confirm device classification early using the Medical Device Classification guide.

Challenge: Difficulty in coordinating testing and audit schedules.

Solution: Plan test license application and lab testing in advance. Choose notified bodies with availability to minimize waiting times.

Challenge: Responding to regulatory queries causing process delays.

Solution: Maintain transparent communication with CDSCO and prepare comprehensive responses backed by technical data.

Expert Consultation and Support

With 25+ years of dedicated experience and over 500 successful CDSCO license applications, our regulatory experts provide tailored support from initial classification to post-license compliance. Our services include:

• Preparing and reviewing Device and Plant Master Files
• Facilitating product testing and audit coordination
• Providing risk management strategy implementation
• Navigating query resolution and compliance updates

Our goal is to simplify your regulatory journey and expedite your market access.

Getting Started with Your CDSCO License Application for Flexible Video Gastroscope

1. Confirm Device Classification: Verify your device as Class B using official CDSCO guidelines.

2. Gather Core Documents: Begin compiling essential documents such as company incorporation, premises proof, and technical staff details.

3. Plan Test License Application: Submit Form MD13 for test license via the CDSCO MD Online Portal to initiate product testing.

4. Engage Testing Laboratories and Notified Bodies: Schedule testing with CDSCO-recognized labs and identify notified bodies for audit.

5. Prepare Device and Plant Master Files: Develop comprehensive files to support your application.

6. Submit Manufacturing License Application (Form MD3): Once testing is complete and documentation is ready, apply for the MD5 license.

7. Respond to Queries Promptly: Ensure timely communication with CDSCO and notified bodies to avoid delays.

By following these precise steps, you can streamline your licensing process and confidently bring your flexible video gastroscope to the Indian healthcare market.