CDSCO License for Uterus-supporting pessary

Comprehensive Guide to CDSCO Licensing for Uterus-Supporting Pessary (Class B Medical Device)

As specialists in medical device regulatory affairs with over 25 years of experience and having assisted 500+ companies successfully navigate the CDSCO licensing landscape, we understand the nuances involved in bringing a uterus-supporting pessary to the Indian market. This obstetrical and gynecological device, classified as a Class B medical device under the CDSCO framework, requires careful adherence to the regulatory process to ensure timely approval and market entry.

Understanding the Uterus-Supporting Pessary and Its Regulatory Significance

A uterus-supporting pessary is a medical device inserted into the vagina to hold the uterus in place, providing critical support for conditions such as uterine prolapse. Given its intimate use and potential impact on patient safety, the Central Drugs Standard Control Organization (CDSCO) classifies this device as Class B, indicating a low to moderate risk level requiring stringent regulatory oversight.

CDSCO Regulatory Framework for Class B Obstetrical and Gynecological Devices

The regulatory pathway for uterus-supporting pessaries falls under the purview of the State Licensing Authority via the MD5 manufacturing license process (Application Form MD3). This pathway ensures that manufacturers comply with quality, safety, and efficacy standards stipulated by CDSCO notifications, including Notification File No. 29/Misc./03/2020-DC (181) dated 03.6.2022.

Risk Classification and License Requirements for Uterus-Supporting Pessaries

• Device Risk Class: Class B (Low to moderate risk)
• Applicable License: MD5 Manufacturing License
• Licensing Authority: State Licensing Authority
• License Form: MD3 for application, MD5 for license grant

Refer to the official Medical Device Classification guide to confirm classifications and regulatory obligations.

Manufacturing License Process (MD5) for Class B Devices

The journey to obtaining the MD5 license for uterus-supporting pessaries typically spans 3 to 4 months and involves the following stages:

1. Test License Application (Form MD13): Initiate by applying for a test license to conduct product testing. This phase takes approximately 1.5 to 2 months.

2. Product Testing: Submit samples to government-approved testing laboratories. Check the list of CDSCO approved testing laboratories for accredited facilities.

3. Documentation Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and others.

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

5. Audit by Notified Body: Following submission, an audit by a notified body is conducted. Refer to the list of notified bodies for audit assignment.

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

7. Grant of License (Form MD5): Upon successful compliance, the license is granted.

Essential Documents Required for MD5 License Application

To streamline your application and minimize delays, ensure you have the following documents ready:

• Certificate of Incorporation and Company Constitution
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications and manufacturing processes. Our detailed Device Master File guide can help you prepare this efficiently.
• Plant Master File (PMF) outlining manufacturing infrastructure and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File documenting risk analysis and mitigation strategies. Refer to our Risk Management resource for best practices.
• Product Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation such as ISO 13485 certificates

Import License Process (MD15) for Uterus-Supporting Pessary

If you are an importer rather than a manufacturer, the import license (MD15) is issued by the Central Licensing Authority and generally takes 5 to 6 months. This process excludes the test license requirement but mandates extensive documentation including:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Address Proof

The application is submitted via the CDSCO MD Online Portal, and fees vary based on your device's risk class.

For detailed guidance, refer to our comprehensive Import License Guide.

Timeline and Processing Duration

Government Fees and Associated Costs

• Test License (MD13): Approximately Rs. 2,000 - Rs. 5,000 depending on state
• MD5 Manufacturing License: Application fee Rs. 5,000 + Rs. 500 per product
• Product Testing: Charges vary by testing lab; typically Rs. 50,000 - Rs. 1,00,000 per product
• Audit Fees: Payable to the notified body as per their tariff

Budgeting for these fees upfront helps avoid procedural delays.

Common Challenges and Practical Solutions

Delays in Testing: Testing at government labs can be time-consuming. To mitigate this, submit samples early and consider parallel documentation preparation.

Incomplete Documentation: Missing or inconsistent documents are the top cause of application rejections. Use a detailed checklist and consult guides like our Device Master File guide to ensure completeness.

Audit Non-Conformities: Proactively prepare for audits by conducting internal mock audits and ensuring your QMS aligns with CDSCO requirements.

Regulatory Updates: Stay updated on changes in CDSCO notifications to avoid compliance gaps.

Expert Consultation and Support

Navigating the CDSCO licensing process for uterus-supporting pessaries can be complex, but with expert guidance, manufacturers and importers can streamline approvals. We offer end-to-end support including:

• Regulatory strategy and risk classification advice
• Preparation of Device and Plant Master Files
• Assistance with test license application and lab coordination
• Documentation review and submission
• Audit readiness and post-audit query management

Our proven track record with over 500 successful client projects ensures you receive reliable, timely assistance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your uterus-supporting pessary is Class B per CDSCO guidelines.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
3. Arrange Product Testing: Coordinate with a government-approved test laboratory.
4. Prepare Documentation: Compile all required files, leveraging our Device Master File and Plant Master File guides.
5. Submit Manufacturing License Application: Complete and submit Form MD3 for the MD5 license.
6. Prepare for Audit: Engage with a notified body and conduct internal audits.
7. Monitor and Respond: Address any queries promptly to facilitate timely license grant.

Starting early and maintaining clear communication with regulatory bodies can reduce processing times and enable faster market entry for your uterus-supporting pessary.

For personalized support and detailed regulatory consulting, contact our team to ensure a smooth, compliant CDSCO licensing journey.