CDSCO License for Spot-film device
Medical Device Information
Intended Use
A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy

Comprehensive Guide to CDSCO Licensing for Spot-film Devices (Class B Medical Devices)
As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing maze, we understand the critical importance of compliance for medical devices such as the Spot-film device. This electromechanical apparatus, integral to fluoroscopic x-ray systems, plays a vital role in interventional radiology by accurately positioning radiographic film cassettes to capture high-quality images during fluoroscopy. Ensuring your spot-film device meets CDSCO regulatory requirements is not just mandatory but essential to gain trust and market access in India.
Understanding the CDSCO Regulatory Framework for Spot-film Devices
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. According to the notification 29/Misc./03/2020-DC (146) dated 26.07.2021, the spot-film device is classified under Class B – a low to moderate risk category.
This classification determines the type of license and the regulatory pathway you must follow. The licensing authority for Class B devices is the State Licensing Authority, and the applicable license is the MD5 Manufacturing License, issued under Form MD3.
For comprehensive clarity on classification, you may refer to the detailed Medical Device Classification guide.
Risk Classification and License Requirements
- Device Name: Spot-film device
- Risk Class: B (Low to Moderate Risk)
- Intended Use: Positioning radiographic film cassette during fluoroscopy
- License Type: MD5 Manufacturing License (for manufacturing within India)
- Regulatory Authority: State Licensing Authority
The MD5 license process is designed to ensure that manufacturers maintain quality standards, comply with safety norms, and validate device performance through government-approved testing laboratories.
Step-by-Step Manufacturing License Process (MD5) for Spot-film Devices
Test License Application (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license, which allows the device to be tested in government-approved laboratories. The test license typically takes 1.5 to 2 months to be granted.
Product Testing: Conduct testing of the spot-film device in laboratories accredited by CDSCO. You can find the list of government-approved testing laboratories here.
Documentation Preparation: Prepare essential documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, and risk management files.
License Application Submission (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will coordinate an audit by a notified body listed here to assess compliance with manufacturing and quality requirements.
Resolution of Queries: Address any observations or queries raised by the notified body or regulatory authority promptly to avoid delays.
Grant of License (Form MD5): Upon successful audit and document review, the MD5 license is granted, allowing you to legally manufacture the spot-film device in India.
For an in-depth walkthrough, our detailed MD5 License guide covers every aspect of this process.
Essential Documents Required for MD5 License Application
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, manufacturing processes, and performance data (Learn more about DMF)
- Plant Master File (PMF): Facility layout, machinery, equipment details, and SOPs (Guide to PMF)
- Essential Principles Checklist
- Risk Management File aligned with ISO 14971 (Risk Management insights)
- Test Reports from Government-Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (e.g., ISO 13485:2016 certification)
Import Licensing Process for Spot-film Devices (If Applicable)
If you intend to import the spot-film device rather than manufacture it domestically, the MD15 Import License applies. This license is issued by the Central Licensing Authority and typically takes 5 to 6 months for approval.
Key steps include:
- Preparation of dossier including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certification, DMF, PMF, and Wholesale License.
- Submission of application on the CDSCO MD Online Portal.
- Addressing queries issued by the licensing authority.
- Grant of MD15 license.
For detailed guidance, consult the Import License guide.
Timelines and Processing Duration for Spot-film Device Licensing
License Type | Steps Involved | Approximate Duration |
---|---|---|
MD5 License | Test License (MD13), Testing, Audit, Application, Queries | 3 to 4 months total |
MD15 License | Document Preparation, Application, Queries, Approval | 5 to 6 months total |
Adhering strictly to documentation requirements and prompt query resolution can prevent common delays.
Government Fees and Associated Costs
MD5 License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD15 Import License:
- For Class B devices, fees typically are around 1,000 per product (fees in INR will vary depending on exchange rates).
Additional costs to budget include:
- Product testing fees at government-approved labs
- Notified body audit fees
- Consultancy and documentation preparation fees (if outsourcing)
Common Challenges Faced by Manufacturers and Practical Solutions
- Incomplete Documentation: Ensure all files such as DMF, PMF, and risk management files are meticulously prepared and updated.
- Delays in Testing: Schedule testing early and select labs with shorter turnaround times.
- Audit Non-Compliance: Conduct internal audits ahead of notified body visits to preempt potential findings.
- Query Resolution Delays: Assign dedicated regulatory personnel to monitor and respond promptly to CDSCO communications.
Our experience shows that proactive planning and leveraging professional support significantly smoothens the licensing journey.
Expert Consultation and Support for Your Spot-film Device Licensing
Navigating CDSCO’s regulatory framework is complex but manageable with expert guidance. We offer end-to-end support including:
- Gap analysis of your current compliance status
- Preparation of Device and Plant Master Files
- Coordination with testing laboratories and notified bodies
- Application submission and follow-up
- Training on post-market surveillance compliance
Our proven track record with over 500 successful licensing projects underscores our commitment to client success.
Getting Started: Practical Next Steps for Your CDSCO License Application
- Initiate Documentation: Begin compiling your DMF, PMF, and QMS documents immediately.
- Apply for Test License (Form MD13): Submit your test license application on the CDSCO MD Online Portal.
- Engage Testing Labs: Identify and liaise with appropriate government-approved labs to schedule product testing.
- Schedule Internal Audits: Prepare for the notified body audit by conducting thorough internal reviews.
- Submit MD5 Application (Form MD3): Once testing is complete and documentation is ready, apply for the MD5 license.
- Maintain Communication: Monitor the application status regularly and respond swiftly to any queries.
Embarking on your licensing journey well-prepared ensures timely market entry and compliance peace of mind. Contact us to leverage our deep expertise for a smooth and efficient CDSCO licensing experience for your spot-film device.