CDSCO License for Flexible video culdoscope

Comprehensive CDSCO Licensing Guide for Flexible Video Culdoscope (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory compliance, we understand the nuances involved in securing a CDSCO license for sophisticated devices like the Flexible Video Culdoscope. This device, intended for visual examination and treatment of the female peritoneal cavity and organs, falls under risk Class B and the Obstetrical and Gynecological category. Our proven track record in helping 500+ companies navigate CDSCO licensing ensures you get practical, reliable guidance tailored to your needs.

CDSCO Regulatory Framework for Flexible Video Culdoscope

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. The Flexible Video Culdoscope is classified as a Class B device, which requires a manufacturing license known as the MD5 license, issued by the State Licensing Authority. Importers also must obtain an MD15 import license from the Central Licensing Authority.

Following the notification (File No. 29/Misc./03/2020-DC (181)) dated 03.6.2022, this device is subject to stringent regulatory requirements to ensure safety and efficacy.

Risk Classification and License Requirements

• Risk Class: B (Low to Moderate Risk)
• Applicable License: MD5 License for manufacturing (Form MD3) from State Authority
• Import License: MD15 License from Central Authority

This classification mandates compliance with the Medical Device Rules, including product testing, audits, and documentation.

Manufacturing License Process for Flexible Video Culdoscope (MD5 License)

The MD5 licensing process is comprehensive and typically spans 3-4 months. It proceeds as follows:

1. Test License Application (Form MD13): Obtain a test license valid for 6 months to begin product testing. This takes about 1.5-2 months.
2. Product Testing: Conduct tests at CDSCO-approved testing laboratories to validate product safety and performance. Refer to the Testing Laboratories list for authorized centers.
3. Document Preparation: Compile all required documents, including Device Master File, Plant Master File, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.
5. Audit by Notified Body: The manufacturing site undergoes an audit by a notified body listed here.
6. Respond to Queries: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon satisfactory compliance, the MD5 license (Form MD5) is issued.

For detailed insights, our MD5 License Guide offers a step-by-step walkthrough.

Manufacturing License Documents Required

For a Flexible Video Culdoscope manufacturing license, prepare the following:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Documents
• Fire Safety and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (DMF Guide)
• Plant Master File outlining manufacturing facilities and quality control processes (PMF Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
• Product Test Reports from CDSCO-recognized labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process for Flexible Video Culdoscope (MD15 License)

For importers, the MD15 license is mandatory and is granted by the Central Licensing Authority. The process generally takes 5-6 months and includes the following steps:

1. Document Preparation: Gather manufacturing license, Free Sale Certificate, ISO certification, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
2. Application Submission: File application on the CDSCO MD Online Portal using Form MD14.
3. Queries Resolution: Promptly respond to any CDSCO department queries.
4. License Issuance: Upon clearance, receive the MD15 import license.

Refer to our comprehensive Import License Guide for detailed information.

Import License Documents Required

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution and Registration Documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 License:

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

• MD15 Import License:

  • For Class B devices:
    • Site Fee: $2,000
    • Per Product Fee: $1,000

Additional costs to budget for include product testing fees, notified body audit charges, and consultation fees if availing expert services.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved labs early and ensure samples meet testing requirements to avoid retesting.

Challenge 2: Incomplete Documentation

• Solution: Meticulously prepare Device Master and Plant Master Files using established templates and checklists. Our Device Master File guide is invaluable here.

Challenge 3: Audit Non-Compliance

• Solution: Conduct pre-audit internal assessments and train your technical staff thoroughly.

Challenge 4: Query Resolution Delays

• Solution: Prepare comprehensive replies with supporting evidence promptly to speed up the review process.

Expert Consultation and Support

Navigating CDSCO's regulatory maze for a device like the Flexible Video Culdoscope requires expert insight. We provide tailored consulting services covering:

• Regulatory strategy and classification
• Documentation preparation and management
• Coordination with notified bodies and testing labs
• Pre-audit readiness and gap analysis
• Application submission and post-submission follow-up

Our clients consistently experience faster approvals and fewer regulatory hiccups by leveraging our expertise.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B and identify license requirements.
2. Initiate Test License Application: Begin with Form MD13 to facilitate product testing.
3. Engage Testing Laboratories: Schedule testing at CDSCO notified labs early to meet timelines.
4. Prepare Comprehensive Documentation: Use our guides to assemble your Device Master File, Plant Master File, and Risk Management File.
5. Identify and Appoint a Notified Body: Choose from the list of notified bodies for your audit.
6. Submit Your Application via CDSCO MD Online Portal: Register and file your applications efficiently through the official portal.
7. Plan for Audit and Query Resolution: Prepare your team and documents for the audit and be ready to respond swiftly to queries.

By following these practical steps and leveraging our extensive experience, you can confidently navigate the CDSCO licensing process for your Flexible Video Culdoscope and successfully enter the Indian medical device market.

For further assistance or personalized support, contact our regulatory experts who specialize in medical device licensing in India.