CDSCO License for Automatic  radiographic film processor

Comprehensive Guide to CDSCO Licensing for Automatic Radiographic Film Processors (Class C)

Navigating India's regulatory landscape for medical devices can be complex, especially for specialized devices like the automatic radiographic film processor. This device, classified as Class C under the CDSCO framework, plays a critical role in interventional radiology by automating the development, fixing, washing, and drying of exposed medical films. With our 25+ years of experience and having guided over 500 companies through the CDSCO licensing process, we bring you an expert roadmap to secure your MD9 manufacturing license efficiently and compliantly.

Understanding the CDSCO Regulatory Framework for Automatic Radiographic Film Processors

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety and efficacy before market entry. The automatic radiographic film processor falls under the Class C risk category due to its critical role in diagnostic imaging workflows. This classification mandates a thorough review by the Central Licensing Authority, requiring a detailed audit, product testing, and robust quality management systems.

The device is notified under Notification No. 29/Misc./03/2020-DC (146) dated 26.07.2021, bringing it under rigorous regulatory scrutiny. The classification and notification mean manufacturers must apply for an MD9 License (Form MD7) to manufacture this device in India.

Risk Classification and License Requirements for Class C Devices

Class C devices are considered moderate to high-risk devices, necessitating:

• MD13 Test License: Preliminary license to conduct testing
• Product Testing: Mandatory testing at CDSCO-approved laboratories
• MD9 Manufacturing License: Final license issued by CDSCO Central Licensing Authority

The entire process is designed to ensure product safety and compliance with Indian regulations.

Step-by-Step Manufacturing License Process (MD9) for Automatic Radiographic Film Processors

1. Obtain Test License (Form MD13):
   • Duration: Approximately 1.5 to 2 months
   • Purpose: Allows sample testing of the device at CDSCO-approved labs
2. Product Testing:
   • Conduct testing at notified laboratories listed on the CDSCO website
   • Testing covers safety, performance, and compliance with essential principles
3. Document Preparation:
   • Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality system documents. Our detailed Device Master File guide and Plant Master File guide can assist you here.
4. Application Submission (Form MD7):
   • Submit through the CDSCO MD Online Portal
   • Include all supporting documents and test reports
5. Audit by CDSCO Inspectors:
   • Audits focus on manufacturing site compliance, QMS, and technical staff qualifications
6. Resolution of Queries:
   • Promptly address any queries raised by the CDSCO department or auditors
7. Grant of License (Form MD9):
   • Upon satisfactory audit and documentation review, the MD9 license is granted

Manufacturing License Documents Required for MD9 Application

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

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement of manufacturing premises
• Technical Staff Details (Qualification and Experience)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File as per international norms (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Automatic Radiographic Film Processors

If you plan to import the device into India, you need to apply for the MD15 license (Form MD14) through the CDSCO Central Licensing Authority. The import license process involves:

• Document preparation including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and relevant master files
• Submission via the CDSCO MD Online Portal
• Addressing any queries from CDSCO authorities

The import license typically takes 5-6 months to process, with fees according to device class.

Timeline and Processing Duration for MD9 License

Planning ahead with realistic timelines is crucial. Delays often arise from incomplete documentation or audit non-compliance.

Government Fees and Costs Breakdown

For Class C devices like the automatic radiographic film processor, the fee structure is as follows:

• Application Fee: Rs. 50,000 per application
• Product Fee: Rs. 1,000 per product variant

This fee is payable via the CDSCO MD Online Portal during the application submission. Additional costs may include fees for testing laboratories and notified body audits.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete or inconsistent documentation.

Solution: Engage regulatory experts early to prepare and review documents. Utilize comprehensive guides for Device and Plant Master Files.

Challenge: Audit non-compliance related to manufacturing practices or QMS.

Solution: Implement ISO 13485 processes and conduct internal audits before CDSCO inspection.

Challenge: Testing delays at government labs.

Solution: Identify multiple CDSCO-approved testing labs to avoid bottlenecks. Our recommended Testing Laboratories list can help.

Expert Consultation and Support

With over 25 years supporting medical device manufacturers, we offer:

• Tailored regulatory strategy for your device
• End-to-end documentation preparation
• Liaison with CDSCO and notified bodies
• Audit readiness and QMS implementation

Our deep familiarity with the nuances of Class C licensing ensures expedited approvals and compliance confidence.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C using the Medical Device Classification resource.
2. Register on the CDSCO MD Online Portal: Create your account early at cdscomdonline.gov.in.
3. Apply for Test License (MD13): Prepare your initial documents and apply promptly.
4. Schedule Product Testing: Coordinate with notified testing laboratories to minimize delays.
5. Prepare Comprehensive Documentation: Use expert guides to assemble DMF, PMF, QMS, and risk management files.
6. Engage with a Notified Body: Identify and collaborate with notified bodies for the mandatory audit.
7. Submit MD9 Application: Ensure all documents and fees are in order.
8. Respond to Queries Quickly: Maintain clear communication with CDSCO officers.

By following these structured steps and leveraging expert support, manufacturers of automatic radiographic film processors can confidently enter the Indian market with timely CDSCO approval.

For personalized assistance and more detailed insights, contact us to discuss your project’s specific needs and timelines.