CDSCO License for Viscera retention paddle or Visceral retainer

Comprehensive Guide to CDSCO Licensing for Viscera Retention Paddle (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies, we understand how crucial it is for manufacturers and importers of Viscera Retention Paddle (also known as Visceral Retainer) to navigate the CDSCO licensing landscape smoothly. This specialized obstetrical and gynecological device, classified as Class B under Indian medical device regulations, requires a well-planned approach to secure the necessary approvals and enter the Indian market efficiently.

Understanding Your Device: Viscera Retention Paddle Overview

The Viscera Retention Paddle is a surgical instrument designed to hold internal organs in place during surgical procedures, particularly for suturing internal wounds. It is temporarily implanted into the surgical site, making it a critical device in obstetrical and gynecological operations. Given its invasive nature and temporary implantation, the device is rightly classified as Class B risk category by CDSCO.

This device falls under the notification File No. 29/Misc./03/2020-DC (181), notified on 03.06.2022, confirming its regulatory classification and applicable requirements.

CDSCO Regulatory Framework for Obstetrical and Gynecological Devices

In India, medical devices like the Viscera Retention Paddle are regulated under the Medical Device Rules (MDR) 2017, governed by the Central Drugs Standard Control Organization (CDSCO). The framework mandates manufacturers to obtain a manufacturing license (MD5 for Class A/B devices) or an import license (MD15) before placing the device on the market.

This ensures compliance with safety, quality, and performance standards, protecting patients and healthcare providers.

Risk Classification and License Requirements for the Viscera Retention Paddle

Your device is classified under Class B, which is considered low to moderate risk. Accordingly, manufacturing licenses are issued by the State Licensing Authority under the MD5 license category using Application Form MD3.

• MD5 License (Class A/B Devices): Manufacturing license issued by state authority.
• Requires prior Test License (Form MD13) for sample testing.

Understanding this classification is essential to plan your licensing strategy accurately. For detailed classification, you can refer to our Medical Device Classification resource.

Step-by-Step Manufacturing License Process (MD5) for Viscera Retention Paddle

1. Obtain Test License (Form MD13):

   • Submit application via CDSCO MD Online Portal for a test license.
   • Test license validity: 6 months, non-renewable.
   • Timeline: Approximately 1.5 to 2 months.

2. Product Testing at Government-Approved Labs:

   • Send device samples to notified testing laboratories.
   • Find a list of approved labs here.
   • Testing typically takes 4 to 6 weeks depending on lab capacity.

3. Document Preparation:

   • Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and QMS documents.
   • For guidance, refer to our Device Master File Guide and Plant Master File Guide.

4. File License Application (Form MD3):

   • Submit the manufacturing license application via the CDSCO MD Online Portal.
   • Include all required documents and test reports.

5. Audit by Notified Body:

   • Your manufacturing facility will be audited by a notified body listed here.
   • Audit ensures compliance with Good Manufacturing Practices (GMP) and QMS.

6. Respond to Queries:

   • CDSCO and the notified body may raise clarifications.
   • Timely and thorough responses help avoid delays.

7. Grant of License (Form MD5):

   • Upon successful audit and document review, the state licensing authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Viscera Retention Paddle

• Company Constitution (Certificate of Incorporation, MOA/AOA)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, intended use, and technical specifications
• Plant Master File (PMF) documenting manufacturing processes and facilities
• Essential Principles Checklist confirming conformity with applicable standards
• Risk Management File explaining hazard analysis and mitigation plans
• Product Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (preferably ISO 13485 compliant)

Accurate and complete document submission is critical to prevent delays. Our team can assist you with document preparation and review to enhance approval chances.

Import License Process (MD15) for Viscera Retention Paddle

If you plan to import the device into India rather than manufacture locally, you must apply for an MD15 import license.

Key steps include:

• Prepare documents such as Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submit application on the CDSCO MD Online Portal.
• Respond to departmental queries.
• Await license grant by the Central Licensing Authority.

The import license process typically takes 5 to 6 months. For further insights, see our Import License Guide.

Timeline and Processing Duration for MD5 License

Government Fees and Costs for MD5 License

• Test License (MD13): No separate fee but part of the process.
• MD5 Manufacturing License:
  • Application Fee: ₹5,000 per application
  • Product Fee: ₹500 per product

Additional costs include:

• Testing laboratory fees (varies by device complexity)
• Notified body audit charges (varies, typically ₹50,000 to ₹1,00,000)
• Consultant fees (if engaged)

Budgeting accurately for these costs upfront helps avoid surprises.

Common Challenges and Practical Solutions

• Delayed Test Reports: Choose notified labs with proven turnaround times and confirm sample requirements in advance.
• Incomplete Documentation: Use detailed checklists and expert reviews to ensure all files like DMF, PMF, and Risk Management Files are comprehensive.
• Audit Non-Compliance: Conduct pre-audit internal assessments and train staff on GMP/QMS.
• Query Backlogs: Maintain clear communication lines with CDSCO and submit prompt, detailed responses.

We recommend scheduling a pre-submission consultation to identify potential gaps early.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like the Viscera Retention Paddle. Our experienced team offers:

• End-to-end application management
• Document drafting and review
• Pre-audit readiness checks
• Liaison with notified bodies and CDSCO officials
• Post-license compliance support

Our proven track record ensures a smoother, faster approval process tailored to your unique device and business model.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm regulatory requirements.
2. Prepare or update your Device and Plant Master Files per CDSCO requirements.
3. Plan and initiate the test license application via the CDSCO MD Online Portal.
4. Engage with an approved testing laboratory early to schedule product tests.
5. Gather all statutory documents, including company and technical staff credentials, NOCs, and QMS evidence.
6. Consider a pre-audit readiness assessment by a notified body to identify compliance gaps.
7. Submit your manufacturing license application (Form MD3) with complete documentation.
8. Prepare for and facilitate the notified body audit efficiently.
9. Respond promptly to all CDSCO queries to avoid processing delays.

Starting early and working methodically through these steps greatly increases your prospects of obtaining the MD5 license within 3 to 4 months.

For personalized guidance tailored to your Viscera Retention Paddle or any other medical device, contact our expert team today to streamline your CDSCO licensing journey.