CDSCO License for Water for Assisted  Reproductive Technologies

Comprehensive Guide to CDSCO Licensing for Water for Assisted Reproductive Technologies (ART)

Water for Assisted Reproductive Technologies (ART) plays a critical role in obstetrical and gynecological procedures, requiring a non-pyrogenic, high-purity grade to ensure patient safety and procedural efficacy. Given its direct application in sensitive ART laboratory procedures, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers targeting the Indian market. With over 25 years of experience helping 500+ companies navigate CDSCO licensing, we provide this detailed, actionable guide to securing your Medical Device License for this Class B device.

CDSCO Regulatory Framework for Water for Assisted Reproductive Technologies

Water used in ART laboratories falls under the Obstetrical and Gynecological category and is classified as a Class B medical device by CDSCO. This classification reflects its medium risk level, necessitating compliance with state-level manufacturing licensing (MD5) and adherence to India’s medical device regulations notified under the Medical Device Rules (MDR), 2017.

The device is notified under File No. 29/Misc./03/2020-DC (181), dated 03.6.2022, confirming its inclusion under the CDSCO regulatory ambit. Compliance ensures safety, quality, and market authorization for your device in India.

Risk Classification and License Requirements

Water for ART is classified as a Class B device – a moderate risk category under India’s MDR. This classification dictates the licensing pathway as follows:

• Manufacturing License: MD5 License (Application Form MD3), issued by the State Licensing Authority
• Import License: MD15 License (Application Form MD14), issued by the Central Licensing Authority

For manufacturers producing Water for ART, the critical license is the MD5 Manufacturing License. Importers will require the MD15 Import License.

Manufacturing License Process (MD5)

The MD5 license process is comprehensive but well-structured. It involves several sequential steps:

1. Test License Acquisition (Form MD13): Before applying for MD5, you must obtain a test license valid for 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to validate compliance with quality standards. A list of approved testing laboratories is available.
3. Document Preparation: Compile essential documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility. Check the list of notified bodies to select an authorized auditor.
6. Queries & Clarifications: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of License (Form MD5): Upon successful compliance, the MD5 license is granted.

Manufacturing License Documents Required

For Water for ART, the following documents are mandatory for the MD5 license application:

• Company Constitution and Registration Proof
• Proof of Ownership/Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing product specifications and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) outlining facility details and quality systems (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian MDR
• Risk Management File specific to Water for ART (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485:2016 compliance is highly recommended)

Import License Process (MD15)

For importers of Water for ART devices, the MD15 import license is mandatory. The process includes:

1. Document Preparation: Collate all required documents, including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, and Wholesale License.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Departmental Review: The Central Licensing Authority reviews the application and raises any queries.
4. Query Resolution: Promptly address queries to avoid processing delays.
5. License Grant: Upon satisfactory review, the MD15 import license is issued.

Import License Documents Required

Key documents for MD15 import license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the competent authority
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution and Registration Proof
• Product Labels and IFU

Timeline and Processing Duration

Manufacturing License (MD5):

• Test License: 1.5 to 2 months
• Product Testing: 3 to 4 weeks
• Audit and Queries: 1 to 1.5 months
• Total Duration: Approximately 3 to 4 months

Import License (MD15):

• Document Preparation: Variable (typically 1 month)
• Application Processing: 4 to 5 months
• Total Duration: Approximately 5 to 6 months

Government Fees and Costs

MD5 Manufacturing License (Class B):

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

MD15 Import License (Class B):

• Site Fee: $2,000 per site
• Per Product Fee: $1,000

These fees are payable online through the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Testing Reports: Testing laboratories can have backlogs; plan your product testing early and choose labs with shorter turnaround times.
• Incomplete Documentation: Missing or inconsistent documents are a major cause of delays. Use comprehensive checklists and expert reviews.
• Audit Non-Compliance: Prepare your facility rigorously for audits by aligning with notified body expectations. Continuous QMS improvements help.
• Query Resolution Delays: Assign dedicated personnel to monitor communications and respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for Class B devices like Water for ART. Our consultancy has successfully guided 500+ companies through this journey, offering:

• Tailored document preparation and review
• Liaison with notified bodies and CDSCO officials
• Audit preparedness training
• Timely submission and query management
• Post-licensing compliance support

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device’s risk class and licensing pathway using resources like the Medical Device Classification guide.
2. Register on CDSCO MD Online Portal: Create your account to access application forms and submission portals.
3. Obtain Test License: Apply for the test license (Form MD13) immediately to begin product testing.
4. Engage a Notified Body: Select and schedule an audit with a notified body listed on the CDSCO portal.
5. Prepare Your Documentation: Use our detailed guides on Device Master File and Plant Master File to ensure completeness.
6. Submit Manufacturing License Application: File your MD5 application through the CDSCO portal once testing and audit are complete.
7. Monitor Application Status: Regularly check the portal and respond to any queries promptly.

By following these structured steps and leveraging expert assistance, manufacturers and importers of Water for Assisted Reproductive Technologies can achieve timely CDSCO license approval, ensuring compliance and market access in India.

For personalized support and turnkey solutions, reach out to our regulatory consultancy team to kickstart your licensing journey with confidence.