CDSCO License for Radiographic grid

Comprehensive Guide to CDSCO Licensing for Radiographic Grid (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 companies, we understand the nuances involved in obtaining the CDSCO license for medical devices like the Radiographic Grid. This device, categorized under Class A and used in interventional radiology, requires meticulous compliance with the Indian regulatory framework to ensure timely market access.

Introduction to Radiographic Grid and Its Regulatory Significance

A Radiographic Grid is a vital device comprising alternating radiolucent and radiopaque strips, positioned between the patient and the image receptor to reduce scattered radiation. This functionality enhances image clarity and diagnostic accuracy in radiography. Given its critical role, the Central Drugs Standard Control Organization (CDSCO) mandates strict regulatory oversight under Notification 29/Misc./03/2020-DC (146) dated 26.07.2021.

Successful licensing not only ensures compliance but also builds trust among healthcare providers and patients, enabling smoother market penetration.

CDSCO Regulatory Framework for Radiographic Grid

In India, medical devices are regulated based on their risk classification. Radiographic Grids fall under Class A, the lowest risk category. The regulatory framework for Class A devices involves obtaining an MD5 manufacturing license from the State Licensing Authority, ensuring adherence to quality, safety, and performance standards.

Manufacturers and importers must comply with the Medical Device Rules, 2017, and subsequent notifications. The entire licensing process is managed through the CDSCO MD Online Portal, which streamlines application submission and tracking.

Risk Classification and License Requirements for Radiographic Grid

According to the Medical Device Rules and the CDSCO classification system, Radiographic Grids are designated as Class A devices due to their low risk profile. This classification mandates the following license requirements:

• Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority.
• Import License: MD15 License (Application Form MD14) issued by the Central Licensing Authority.

For manufacturing, an MD5 license is mandatory before commercial production.

Manufacturing License Process (MD5) for Radiographic Grid

The MD5 licensing process involves several critical steps:

1. Test License (Form MD13): Before applying for MD5, manufacturers must obtain a test license, which permits pilot production to facilitate product testing.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories.
3. Document Preparation: Compile all necessary technical and quality documents.
4. License Application (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit: Undergo an audit by a notified body. Check the list of notified bodies for authorized auditors.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. Grant of License (Form MD5): Upon successful completion, the manufacturing license is issued.

Manufacturing License Documents Required for Radiographic Grid

The documentation is critical and must be meticulously prepared. Key documents include:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) – our Device Master File guide can assist in preparing this
• Plant Master File (PMF) – see our Plant Master File guide
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File tailored for Radiographic Grid devices (refer to our Risk Management guide)
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Radiographic Grid

For importers of Radiographic Grids, an MD15 license is mandatory. The process includes:

1. Document Preparation: Assemble required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, and ISO 13485:2016 certification.
2. Application Submission: File the application on the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any department queries.
4. Grant of Import License (Form MD15): License is issued after satisfactory evaluation.

Import License Documents Required for Radiographic Grid

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution

Timeline and Processing Duration

Understanding timelines helps in effective planning:

• MD5 Manufacturing License: Approximately 3-4 months.

  • Test license (MD13): 1.5-2 months
  • Product testing: 1 month
  • Document preparation and audit: 3-4 weeks
  • Query resolution and license grant: 2-3 weeks

• MD15 Import License: Approximately 5-6 months.

Government Fees and Costs for Radiographic Grid Licensing

• MD5 Manufacturing License:

  • Application fee: Rs. 5,000
  • Per product fee: Rs. 500

• MD15 Import License:

  • For Class A devices: $1,000 per site +$50 per product

Note: Fees are subject to change; always verify the latest fee structure on the official portal.

Common Challenges and Practical Solutions

Manufacturers and importers often face hurdles such as:

• Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are comprehensive and aligned with CDSCO guidelines.
• Delayed Testing: Plan testing well in advance; choose CDSCO-approved labs with shorter turnaround times.
• Audit Non-compliance: Conduct pre-audit internal checks and corrective actions.
• Query Resolution Delays: Assign dedicated personnel for timely responses.

Proactive planning and expert guidance can significantly mitigate these challenges.

Expert Consultation and Support for Radiographic Grid Licensing

With our extensive experience in assisting over 500 companies, we offer end-to-end support—from document preparation, testing coordination, audit facilitation, to application follow-up. Leveraging our expertise can accelerate your licensing process and ensure compliance.

Getting Started with Your CDSCO License Application for Radiographic Grid

1. Register on the CDSCO MD Online Portal.
2. Prepare your test license application (Form MD13) to initiate pilot production.
3. Engage with notified bodies and testing labs early to schedule audits and tests.
4. Compile complete documentation using our guides on Device and Plant Master Files.
5. Submit your MD5 license application (Form MD3) post successful testing and audit.
6. Maintain open communication with CDSCO authorities for smooth query resolution.

Starting your CDSCO licensing journey with a clear roadmap and expert assistance is critical to bringing your Radiographic Grid to the Indian healthcare market efficiently and compliantly.