CDSCO License for Vaginal douche, reusable or single use

Comprehensive Guide to CDSCO Licensing for Vaginal Douche (Class B Medical Device)

As a medical device manufacturer or importer aiming to enter the Indian market with a vaginal douche—either reusable or single-use—you must navigate the stringent regulatory framework set by the Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience assisting 500+ companies, we provide you an expert, step-by-step guide to securing the necessary CDSCO license (MD5) for your Class B obstetrical and gynecological device.

Understanding the Vaginal Douche and Its Regulatory Importance

A vaginal douche is designed to deliver a liquid solution directly into the vaginal cavity for hygienic purposes. Classified under the obstetrical and gynecological category and designated as a Class B device (moderate risk), it requires regulatory oversight to ensure safety and efficacy for consumers. The CDSCO’s notification (File No. 29/Misc./03/2020-DC (181), dated 03.06.2022) formally recognizes this device category, mandating compliance with Indian medical device regulations.

CDSCO Regulatory Framework for Vaginal Douche (Class B)

Medical devices in India are regulated under the Medical Device Rules (MDR) 2017, which classify devices based on risk. Class B devices like vaginal douches require a manufacturing license (MD5) issued by the State Licensing Authority. This license ensures your manufacturing processes, quality management, and product safety meet Indian standards.

Manufacturers must first obtain a test license (MD13) to conduct product testing in government-approved labs before applying for the final manufacturing license.

Risk Classification and License Requirements

• Device Risk Class: B (Moderate Risk)
• License Type Required: MD5 (Manufacturing License for Class A and B devices)
• Approving Authority: State Licensing Authority

The medical device classification confirms that vaginal douches fall under Class B due to their invasive nature but moderate risk profile.

Manufacturing License Process for Vaginal Douche (MD5)

The entire MD5 license process typically takes 3 to 4 months and involves the following steps:

1. Apply for Test License (Form MD13): This initial step takes approximately 1.5 to 2 months. You must submit device samples to government-approved testing laboratories for safety and performance evaluation.
2. Product Testing: Testing is done at notified labs. You can find the list of CDSCO-approved testing laboratories here.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Application Submission (Form MD3): Submit your MD5 license application with all supporting documents through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body conducts an on-site audit of your manufacturing facility and quality management system. Refer to the list of notified bodies for audit agencies.
6. Query Resolution: Address any queries raised by the notified body or CDSCO during the review process.
7. Grant of MD5 License (Form MD5): Upon satisfactory evaluation, the license is issued.

Manufacturing License Documents Required for Vaginal Douche

To ensure a smooth application, prepare the following key documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, manufacturing process. Our Device Master File guide explains this in depth.
• Plant Master File (PMF): Manufacturing environment, equipment details, and process controls. See our Plant Master File guide for practical tips.
• Essential Principles Checklist: Compliance with safety and performance principles.
• Risk Management File: Per ISO 14971 standards. Learn how to implement risk management.
• Test Reports from Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, including ISO 13485 certification

Import License Process (MD15) for Vaginal Douche

If you are an importer rather than manufacturer, you need an MD15 import license granted by the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

• Preparation of documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files.
• Submission of Form MD14 on the CDSCO MD Online Portal.
• Resolution of any queries.
• Grant of MD15 license.

For detailed guidance, our Import License guide is a valuable resource.

Timeline and Processing Duration

Total Time: Approximately 3 to 4 months

Government Fees and Costs

• Test License (MD13): Nil or minimal processing fees per state norms
• MD5 License Application Fee: ₹5,000 per application
• Product-wise Fee: ₹500 per product

Additional costs include expenses for testing (labs may charge fees based on sample types), notified body audit fees, and preparation of documentation.

Common Challenges and Solutions

• Delays in Product Testing: Testing labs may have backlogs. Plan sample submission early and maintain communication with labs.
• Incomplete Documentation: Missing or poorly prepared Device Master File or Risk Management File causes delays. Engage experts or refer to detailed guides.
• Non-compliance during Audit: Ensure your manufacturing facility and QMS strictly adhere to ISO 13485 and CDSCO norms before audit.
• Query Resolution Delays: Respond comprehensively and promptly to all CDSCO and notified body queries.

Expert Consultation and Support

Our extensive experience working with over 500 companies uniquely positions us to assist you in every step—from documentation to audit preparation and query handling. We ensure your vaginal douche device complies fully, reducing approval times and avoiding costly rejections.

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm Class B status and understand applicable regulations.
2. Prepare Your Samples and Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management files.
3. Apply for Test License (MD13): Submit samples to approved labs via the CDSCO MD Online Portal.
4. Schedule Testing and Prepare for Audit: Coordinate with notified bodies early.
5. Submit MD5 License Application: After successful testing, apply online and prepare for the audit.
6. Engage Expert Support: Consult with experienced regulatory professionals to navigate complex requirements efficiently.

Embarking on your regulatory journey with a clear roadmap and expert guidance will significantly enhance your chances of timely CDSCO license approval for your vaginal douche device in India.