CDSCO License for Radiographic film cassette

Comprehensive Guide to CDSCO Licensing for Radiographic Film Cassette (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we understand the complexities and nuances involved in the Indian medical device regulatory landscape. This guide focuses specifically on the Radiographic Film Cassette, a Class B medical device used in interventional radiology for diagnostic x-ray procedures.

Introduction to Radiographic Film Cassette and Regulatory Importance

A Radiographic Film Cassette serves a critical role by securely holding the film in close proximity to the x-ray intensifying screen, while providing a light-proof enclosure for direct exposure of radiographic film. Its proper functioning ensures high-quality diagnostic images essential for patient care. Given its direct involvement in diagnostic procedures, the CDSCO mandates strict regulatory compliance to ensure safety, efficacy, and quality.

CDSCO Regulatory Framework for Radiographic Film Cassettes

Radiographic Film Cassettes fall under Class B (low-moderate risk) devices as per the Medical Device Classification notified by CDSCO through Notification 29/Misc./03/2020-DC (146) dated 26.07.2021. This classification triggers specific licensing procedures governed by the State Licensing Authority under the MD5 license category.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B
• License Type: MD5 Manufacturing License
• Governing Authority: State Licensing Authority
• Key Compliance: Test license (MD13), product testing in government-approved labs, audit by notified bodies

Manufacturing License Process (MD5) for Radiographic Film Cassette

1. Obtain Test License (Form MD13): Initially, apply for a test license which permits manufacturing for testing purposes.
2. Product Testing: Conduct mandatory testing at CDSCO-approved testing laboratories to validate device safety and performance. Refer to the Testing Laboratories list for authorized labs.
3. Document Preparation: Compile required documentation including Device Master File, Plant Master File, and Risk Management File.
4. Apply for MD5 License (Form MD3): Submit the application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a rigorous audit by an authorized notified body. You can check the list of notified bodies to select your auditing agency.
6. Respond to Queries: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon successful review and audit, the MD5 license is issued.

Manufacturing License Documents Required for Radiographic Film Cassette

• Company Constitution documents (e.g., MOA, AOA)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed product specifications, manufacturing process, and quality parameters (Device Master File Guide)
• Plant Master File (PMF): Manufacturing site details, quality systems, and infrastructure (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with CDSCO standards
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-recognized labs
• Product labels and Instructions for Use (IFU) conforming to regulatory norms
• Quality Management System (QMS) documentation (preferably ISO 13485:2016 certified)

Import License Process (MD15) for Radiographic Film Cassette

For companies importing Radiographic Film Cassettes, the MD15 import license is required from the Central Licensing Authority. The process involves:

• Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, and CE certificate.
• Submission of application using Form MD14 on the CDSCO MD Online Portal.
• Query resolution and final license issuance.

Typically, no test license is required for importers.

Import License Documents Required

• Manufacturing license of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license (if applicable)
• Company constitution documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test license (MD13): 1.5-2 months
  • Product testing: 3-4 weeks (may vary depending on lab backlog)
  • Audit and document review: 1-1.5 months

• MD15 Import License: 5-6 months

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Example: For a manufacturer applying for 3 radiographic film cassette variants, total fees = Rs 5,000 + (3 x Rs 500) = Rs 6,500

Additional costs include:

• Testing laboratory fees (varies, approx. Rs 30,000 - Rs 80,000 depending on tests)
• Notified body audit fees (varies, typically Rs 50,000 - Rs 1,00,000)
• Consultancy and documentation preparation (if outsourced)

Common Challenges and Practical Solutions

• Delayed Testing: Testing lab backlogs can extend timelines. Our advice is to pre-book slots early with approved labs.
• Document Gaps: Incomplete Device or Plant Master Files often trigger queries. Use our comprehensive Device Master File guide and Plant Master File guide to prepare robust files.
• Audit Non-compliance: Prepare thoroughly for notified body audits by conducting internal audits and mock inspections.
• Frequent Queries: Respond promptly and with complete documentation to minimize back-and-forth.

Expert Consultation and Support

Our extensive experience means we can help streamline your license application from start to finish—ensuring compliance, avoiding common pitfalls, and accelerating approvals. Whether you need assistance preparing test license applications, coordinating product testing, or compiling your technical documentation, our team is ready to support you.

Getting Started with Your CDSCO License Application

1. Classify your device accurately as Class B and confirm intended use.
2. Register on the CDSCO MD Online Portal and create your account.
3. Apply for the Test License (Form MD13) to begin manufacturing for testing.
4. Engage a CDSCO-approved testing laboratory early to schedule product testing.
5. Start preparing your Device Master File and Plant Master File using expert guides.
6. Identify and appoint a notified body from the official list for your audit.
7. Compile all required documents and submit your MD5 license application (Form MD3) on the portal.
8. Prepare for and coordinate the audit while promptly addressing any queries.

Taking these actionable steps with expert guidance can significantly smooth your path to obtaining the CDSCO MD5 manufacturing license for Radiographic Film Cassettes. Contact us to leverage our expertise and ensure your successful entry into the Indian medical device market.