CDSCO License for Radiographic film/cassette changer
Medical Device Information
Intended Use
A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
Comprehensive Guide to CDSCO Licensing for Radiographic Film/Cassette Changer (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 companies, we understand the complexities involved in acquiring CDSCO licenses in India. This guide focuses on the Radiographic Film/Cassette Changer, a Class B medical device used in interventional radiology to position radiographic films or cassettes during X-ray procedures.
Understanding the Device and Regulatory Importance
A radiographic film/cassette changer plays a critical role in radiologic procedures, ensuring accurate positioning between exposures. Given its direct involvement in patient imaging, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures device safety, efficacy, and compliance with Indian standards under the notification 29/Misc./03/2020-DC (146).
CDSCO Regulatory Framework for Radiographic Film/Cassette Changers
In India, medical devices are regulated under the Medical Device Rules 2017 (MDR 2017), with classification based on risk. The radiographic film/cassette changer falls under Class B (Low-Moderate Risk) and is subject to licensing requirements by the State Licensing Authority.
Risk Classification and License Requirements
| Risk Class | License Type | Licensing Authority | Processing Time | Fees (INR) |
|---|---|---|---|---|
| Class B | MD5 License | State Licensing Authority | 3-4 months | Rs. 5,000 + Rs. 500/product |
The MD5 license is mandatory for manufacturing Class B devices like the radiographic film/cassette changer. This license ensures compliance with quality management systems and safety standards.
Manufacturing License Process (MD5 License)
The MD5 license process involves several stages:
Test License (Form MD13): Initially, manufacturers must obtain a Test License, which allows product testing at government-approved labs. This phase takes approximately 1.5 to 2 months.
Product Testing: Testing is conducted at CDSCO-approved laboratories to verify compliance with essential principles and standards. Refer to the list of testing laboratories for accredited facilities.
Document Preparation: Compilation of mandatory documents including Device Master File and Plant Master File.
Application Submission (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: An audit assesses compliance with MDR 2017 and Good Manufacturing Practices (GMP). Manufacturers can check the list of notified bodies for audit authorization.
Query Resolution: Address any observations or queries raised by CDSCO or the notified body.
Grant of License (Form MD5): After successful audit and document verification, the license is granted.
Manufacturing License Documents Required
For the radiographic film/cassette changer, the following documents are essential:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing facilities and quality controls (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File reflecting hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 compliant)
Import License Process (MD15 License)
For companies importing radiographic film/cassette changers, an MD15 import license granted by the Central Licensing Authority is mandatory. The process generally takes 5-6 months and requires:
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Apply through the CDSCO MD Online Portal using Form MD14.
Import License Documents Required
- Valid Manufacturing License of Origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Mark Certificate
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 1 – 2 weeks |
| Application Submission | Immediate |
| Audit & Inspection | 3 – 4 weeks |
| Query Resolution | 2 – 4 weeks |
| License Grant | Upon clearance |
Total timeline for MD5 license: approximately 3-4 months.
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs to consider:
- Testing fees at government-approved labs (varies by device complexity)
- Notified body audit fees
- Consultant fees if engaging regulatory expertise
Common Challenges and Solutions
Challenge 1: Delays in Testing – Testing turnaround times may extend due to lab backlogs.
- Solution: Schedule tests early and confirm lab availability in advance.
Challenge 2: Documentation Gaps – Incomplete or inconsistent documentation causes audit delays.
- Solution: Use checklists and consult expert guidance on Device Master File and Plant Master File preparation.
Challenge 3: Query Resolution Delays – Unclear responses can prolong approval.
- Solution: Prepare detailed, clear replies supported by evidence and maintain open communication with CDSCO.
Expert Consultation and Support
Navigating the CDSCO licensing process for devices like the radiographic film/cassette changer demands technical knowledge and procedural expertise. Our proven approach includes:
- Customized gap analysis and compliance roadmaps
- End-to-end document preparation
- Coordination with notified bodies and testing labs
- Timely follow-up on application status
We recommend partnering with experienced consultants to minimize risks and accelerate market entry.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Class B under Indian regulations by reviewing medical device classification.
Engage a Testing Laboratory: Contact a CDSCO-approved lab early to plan testing timelines (Testing Laboratories).
Prepare Documentation: Develop your Device Master File and Plant Master File, ensuring comprehensive risk management and quality system documentation.
Apply for Test License: File Form MD13 via the CDSCO MD Online Portal to commence product testing.
Coordinate Audit: Post-testing, schedule the notified body audit for your manufacturing site.
Submit MD5 Application: Once all documents and audit reports are ready, apply for the MD5 manufacturing license to the State Licensing Authority.
Respond to Queries Promptly: Address any CDSCO or audit observations to avoid unnecessary delays.
By following these steps and leveraging our extensive regulatory expertise, manufacturers and importers of radiographic film/cassette changers can achieve timely CDSCO licensing and successful market entry in India.
