CDSCO License for Polyvinylpyrrolidone (PVP) Solution

Comprehensive CDSCO Licensing Guide for Polyvinylpyrrolidone (PVP) Solution – Class C Medical Device

As specialists with over 25 years’ expertise in medical device regulatory compliance and having supported 500+ companies in India, we understand the critical importance of securing timely and accurate CDSCO licensing for devices like Polyvinylpyrrolidone (PVP) Solution. This product, classified as a Class C medical device under Obstetrical and Gynecological categories, plays a vital role in assisted reproductive technologies, specifically in sperm immobilization for ICSI procedures.

Understanding the Device and Its Regulatory Importance

Polyvinylpyrrolidone (PVP) Solution is widely used in assisted reproductive procedures involving human gamete and embryo manipulation. It often contains protein supplements such as Human Serum Albumin (HSA) to enhance efficacy. Due to its direct interaction with human gametes and embryos, it is rightly classified as a Class C device, indicating moderate to high risk, thereby necessitating stringent regulatory oversight.

This device falls under the notification File No. 29/Misc./03/2020-DC (181), notified on 03.06.2022 by CDSCO, emphasizing its regulated status in India.

CDSCO Regulatory Framework for Polyvinylpyrrolidone (PVP) Solution

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India, categorizing them from Class A (low risk) to Class D (high risk). Class C devices like PVP Solution require a manufacturing license from the Central Licensing Authority (CLA) via the MD9 license pathway.

Manufacturers or importers must comply with the Medical Device Rules, 2017, ensuring quality, safety, and efficacy for market authorization.

Risk Classification and License Requirements for Class C Devices

Class C devices involve moderate to high risk and require:

• Manufacturing License (MD9 License) – For Indian manufacturers, issued by CDSCO CLA.
• Import License (MD15 License) – For importers importing Class C devices.

Due to the device's risk profile, the MD9 license application involves rigorous testing, documentation, and audit requirements.

Manufacturing License Process (MD9) for PVP Solution

The MD9 license process is comprehensive, typically lasting 4 to 5 months, and includes the following steps:

1. Test License Application (Form MD13) – Obtain a test license enabling sample testing. This takes approximately 1.5 to 2 months.
2. Product Testing – Conduct mandatory testing through government-approved labs (refer to the list of testing laboratories).
3. Document Preparation – Compile all necessary technical and quality documentation.
4. Application Submission (Form MD7) – Apply for the MD9 manufacturing license through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors – On-site audit to verify compliance.
6. Resolution of Queries – Respond to any departmental or audit observations.
7. Grant of License (Form MD9) – Upon satisfactory compliance, the license is issued.

Document Requirements for MD9 License Application

For Polyvinylpyrrolidone (PVP) Solution, the following documents must be meticulously prepared:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership/Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing product specifications, formulation, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian regulatory requirements
• Risk Management File outlining hazard identification and mitigation strategies (Risk Management)
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Polyvinylpyrrolidone (PVP) Solution

For importers of Class C devices like PVP Solution, obtaining an MD15 import license from CDSCO’s central authority is mandatory. The process spans approximately 5 to 6 months and includes:

• Comprehensive document preparation
• Submission of application via CDSCO MD Online Portal
• Resolution of departmental queries
• Grant of MD15 import license

Import License Documents Required:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

For Class C Polyvinylpyrrolidone (PVP) Solution licensing:

• MD9 Manufacturing License Fees:

  • Rs 50,000 per application
  • Rs 1,000 per product

• MD15 Import License Fees:

  • Rs 3,000 per site
  • Rs 1,500 per product

Additional costs include fees for product testing at approved labs and audit charges from notified bodies if applicable.

Common Challenges and Practical Solutions

Challenge 1: Delays in Document Preparation Many manufacturers underestimate the complexity of compiling the Device and Plant Master Files. Our recommendation: start early, and leverage templates aligned with CDSCO expectations. Our Device Master File guide can help streamline this process.

Challenge 2: Product Testing Bottlenecks Testing backlogs at government labs can extend timelines. Engage labs early, confirm test parameters, and consider pre-submission consultations.

Challenge 3: Non-compliance during Audit Audits can reveal gaps in QMS or documentation. Regular internal audits and mock inspections can prepare your team effectively.

Challenge 4: Query Resolution Delays Fast and precise responses to CDSCO queries are critical. Maintain a dedicated regulatory liaison to ensure swift communication.

Expert Consultation and Support

Our team’s extensive experience navigating CDSCO’s regulatory landscape ensures a smooth licensing journey. From pre-application assessments, document preparation, to audit readiness and query management, we provide end-to-end support tailored to Class C devices like PVP Solution.

Getting Started with Your CDSCO License Application

1. Assess your device classification and intended use to confirm regulatory pathway.
2. Initiate product testing by applying for the test license (Form MD13) on the CDSCO MD Online Portal.
3. Compile comprehensive documentation, including Device and Plant Master Files.
4. Schedule product testing at government-approved laboratories.
5. Prepare your Quality Management System aligned to ISO 13485.
6. Submit your MD9 manufacturing license application (Form MD7) via the CDSCO portal.
7. Prepare for audit by conducting internal reviews and mock inspections.

By following this structured approach and leveraging our expertise, medical device manufacturers and importers can confidently navigate the CDSCO licensing process for Polyvinylpyrrolidone (PVP) Solution and successfully enter the Indian market.

For detailed assistance on MD9 licensing, explore our comprehensive MD9 License Guide.

We invite you to contact us to initiate your application process or for personalized consultations to expedite your CDSCO licensing journey.