CDSCO License for Menstrual Cup

Comprehensive Guide to CDSCO Licensing for Menstrual Cups (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory consulting, we have successfully guided 500+ manufacturers and importers to obtain CDSCO licenses in India. In this detailed guide, we focus on the regulatory pathway for Menstrual Cups, a Class B obstetrical and gynecological medical device, intended to collect menstrual blood and cellular debris. This device category is notified under File No. 29/Misc./03/2020-DC (181), dated 03.6.2022, making compliance with CDSCO guidelines essential for market entry.

CDSCO Regulatory Framework for Menstrual Cups

Menstrual Cups fall under the Class B risk category according to the CDSCO classification system. This means the device poses moderate risk, requiring a manufacturing license (MD5) granted by the State Licensing Authority. The regulatory framework mandates adherence to quality standards, safety requirements, and a thorough evaluation process including product testing and audits.

The entire regulatory process is designed to ensure patient safety without unnecessary delays.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Authority: State Licensing Authority

This classification requires manufacturers to obtain a test license (Form MD13) initially, followed by product testing from government-approved laboratories, preparation of detailed documentation, and a notified body audit.

For detailed classification information, visit our Medical Device Classification guide.

Manufacturing License Process for Menstrual Cups (MD5)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 license, manufacturers must secure a test license for the menstrual cup. This license allows the device to be tested in government-recognized laboratories.

• Timeline: Approximately 1.5 to 2 months
• Purpose: To legally send samples for testing

Step 2: Product Testing

Samples of the menstrual cup must be tested in laboratories approved by CDSCO to evaluate compliance with Indian standards and essential principles.

• Access the list of approved Testing Laboratories here.
• Testing typically covers biocompatibility, sterility (if applicable), mechanical integrity, and labeling compliance.

Step 3: Documentation Preparation

Comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS), and risk management files must be prepared meticulously.

• Our Device Master File guide and Plant Master File guide provide detailed instructions.

Step 4: Application Submission for MD5 License

Submit the application using Form MD3 via the CDSCO MD Online Portal.

• Include all required documents
• Pay fees as per government norms

Step 5: Notified Body Audit

A notified body will conduct an audit of the manufacturing facility and documentation.

• Reference the list of notified bodies for audit assignments

Step 6: Resolution of Queries

Address any observations or queries from CDSCO or the notified body promptly to avoid delays.

Step 7: Grant of MD5 License

Upon successful audit and document verification, CDSCO grants the manufacturing license on Form MD5.

Manufacturing License Documents Required for Menstrual Cups

1. Company Constitution Documents (e.g., Incorporation Certificate, Partnership Deed)
2. Proof of Ownership/Lease of Manufacturing Premises
3. Technical Staff Details and Qualifications
4. Fire NOC and Pollution Control NOC
5. Device Master File (DMF)
6. Plant Master File (PMF)
7. Essential Principles Checklist Compliance Document
8. Risk Management File (as per ISO 14971 principles)
9. Test Reports from Approved Laboratories
10. Labels and Instructions for Use (IFU)
11. Quality Management System Documents (preferably ISO 13485:2016 certified)

Pay special attention to the Device Master File and Risk Management File, as these are critical for demonstrating the safety and efficacy of menstrual cups.

Import License Process (MD15) for Menstrual Cups

For importers, the MD15 license is mandatory, issued by the Central Licensing Authority.

• No test license required
• Submit application on Form MD14 via the CDSCO MD Online Portal
• Documents required include Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution

Timeline: Approximately 5-6 months

Fees: Variable based on risk class and number of products

For comprehensive import licensing guidance, see our Import License Guide.

Timeline and Processing Duration

Proactive communication and thorough documentation can significantly reduce delays.

Government Fees and Costs

• Test License (MD13): Nominal fee, varies by state
• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product

Additional costs include:

• Laboratory testing fees
• Notified body audit charges (varies by body)
• Consultant fees if opting for expert support

Early budgeting for these expenses ensures smooth financial planning.

Common Challenges and Solutions

• Incomplete Documentation: Use detailed checklists and templates to avoid missing documents.
• Delays in Product Testing: Choose testing labs with proven turnaround times and submit samples early.
• Audit Non-compliance: Conduct internal audits and pre-assessment to prepare for notified body inspections.
• Query Resolution Delays: Maintain a dedicated regulatory team for prompt responses.

Our practical experience reveals that many manufacturers save months by preparing thoroughly and engaging expert consultants.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for novel devices like menstrual cups. Our team has helped over 500 companies seamlessly obtain licenses by:

• Preparing complete and compliant documentation
• Coordinating with testing labs and notified bodies
• Managing timelines and government communications

Engaging expert consultants reduces your risk of rejection, accelerates approvals, and ensures compliance with evolving regulations.

Getting Started with Your CDSCO License Application for Menstrual Cups

1. Evaluate your device classification and confirm it falls under Class B.
2. Register on the CDSCO MD Online Portal to create your application account.
3. Initiate the Test License application (Form MD13) to begin testing.
4. Identify and liaise with CDSCO-approved testing laboratories early.
5. Collect and organize all required documentation, leveraging our Device and Plant Master File guides.
6. Schedule the notified body audit once product testing is complete.
7. Prepare for prompt query resolution by assigning a regulatory affairs point person.

By following these actionable steps and leveraging our experience, manufacturers and importers of menstrual cups can confidently enter the Indian market with full CDSCO compliance.

For a tailored consultation or assistance with your Menstrual Cup licensing, contact us today and benefit from our 25+ years of proven expertise.