CDSCO License for Powered remote irradiation therapy table

Introduction to Powered Remote Irradiation Therapy Table and Regulatory Importance

The Powered Remote Irradiation Therapy Table is a sophisticated, programmable electrically operated bed specifically designed to facilitate precise patient positioning and immobilization during radiotherapy treatments using remote cobalt 60 or other radionuclide apparatuses. Given its critical role in patient safety and treatment efficacy, regulatory compliance is paramount. In India, the Central Drugs Standard Control Organization (CDSCO) regulates such medical devices to ensure their safety, quality, and performance before market entry.

With over 25 years of experience helping more than 500 companies navigate the complex CDSCO licensing landscape, we understand the nuances involved in securing the necessary approvals for Class B radiotherapy devices like this. This guide provides detailed, actionable insights into obtaining a CDSCO manufacturing license (MD5) for your Powered Remote Irradiation Therapy Table.

CDSCO Regulatory Framework for Radiotherapy Devices

The CDSCO governs medical devices under the Medical Device Rules, 2017, categorizing devices based on risk to patients and users. Radiotherapy devices fall under specialized regulatory scrutiny due to their direct involvement in treatment delivery and patient safety. The notification for Powered Remote Irradiation Therapy Tables is listed under File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, which classifies this device as Class B, indicating a moderate risk profile.

The regulatory pathway mandates manufacturers to obtain a manufacturing license from the State Licensing Authority through the MD5 route (Form MD3) for Class A and B devices. This process ensures that the device meets all essential safety and quality parameters before entering the Indian market.

Risk Classification and License Requirements for Class B Devices

The Powered Remote Irradiation Therapy Table is classified as a Class B medical device. Class B devices are moderate risk and require adherence to specific regulatory controls including:

• Obtaining a Test License (Form MD13) prior to manufacturing
• Product testing from CDSCO-approved laboratories
• Submission of comprehensive technical documentation
• Successful completion of a notified body audit
• Final approval and grant of the manufacturing license (MD5)

For detailed information on medical device classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Powered Remote Irradiation Therapy Table

Step 1: Obtain Test License (Form MD13)

The first step involves applying for a Test License using Form MD13 through the CDSCO MD Online Portal. This license allows you to manufacture the device for testing purposes only. The Test License application processing typically takes 1.5 to 2 months.

Step 2: Product Testing

Once the test license is granted, the device samples must be tested at a government-approved laboratory to verify compliance with applicable standards. A list of these labs can be found on the CDSCO Testing Laboratories page.

Step 3: Document Preparation

Parallel to testing, manufacturers should prepare the complete documentation package including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, and others as required.

Step 4: Application for Manufacturing License (Form MD3)

Submit the manufacturing license application (Form MD3) for MD5 through the CDSCO portal. This submission includes all documents, test reports, and audit readiness evidence.

Step 5: Audit by Notified Body

The State Licensing Authority will assign a notified body to conduct an audit of your manufacturing facility. You can check the list of notified bodies to identify qualified auditors. The audit focuses on manufacturing processes, quality controls, and documentation compliance.

Step 6: Resolution of Queries

Post-audit, you may receive queries or requests for additional information from the notified body or the CDSCO. Timely and detailed responses are critical to avoid delays.

Step 7: Grant of MD5 License

Upon satisfactory audit and query resolution, the State Licensing Authority grants the manufacturing license on Form MD5, authorizing commercial production.

Manufacturing License Documents Required for Powered Remote Irradiation Therapy Table

Thorough documentation is essential. The key documents include:

• Company Constitution (Incorporation Certificate, Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device design, specifications, and performance data. Refer to our detailed Device Master File guide.
• Plant Master File (PMF): Manufacturing facility and process details. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File documenting hazard analysis and mitigation strategies. See our Risk Management guide.
• Product test reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 compliant

Import License Process (MD15) for Powered Remote Irradiation Therapy Table

If you intend to import the Powered Remote Irradiation Therapy Table into India, an Import License (Form MD15) from the Central Licensing Authority is mandatory. The process involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files
• Submission of Form MD14 application on the CDSCO MD Online Portal
• Resolution of any CDSCO queries
• License grant within approximately 5-6 months

For more details, consult our Import License guide.

Timeline and Processing Duration

Being proactive in document readiness and query responsiveness can significantly reduce delays.

Government Fees and Costs

• Test License (MD13): Included in the overall licensing process
• Manufacturing License (MD5): Rs. 5,000 per application plus Rs. 500 per product
• Product Testing Fees: Variable depending on the testing laboratory and number of tests
• Audit Fees: Typically borne by the manufacturer, varies by notified body

These fees are payable through the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing Solution: Engage with CDSCO-approved labs early to schedule testing and understand test requirements.

Challenge 2: Incomplete Documentation Solution: Use checklists and professional templates for Device and Plant Master Files; consider expert consultation.

Challenge 3: Audit Non-compliance Solution: Conduct internal pre-audit assessments and ensure QMS implementation aligns with ISO 13485 standards.

Challenge 4: Query Mismanagement Solution: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO and notified body queries.

Expert Consultation and Support

Navigating CDSCO licensing for a specialized device like the Powered Remote Irradiation Therapy Table requires expertise. Our team, with over 25 years of experience and 500+ successful client projects, offers:

• End-to-end application preparation
• Document drafting and review
• Pre-audit inspections and gap analysis
• Liaison with notified bodies and CDSCO officials
• Post-license compliance support

Our proactive approach reduces approval time and ensures regulatory compliance, facilitating smoother market entry.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing process for the Powered Remote Irradiation Therapy Table:

1. Register your organization on the CDSCO MD Online Portal.
2. Prepare and submit the Test License application (Form MD13) with preliminary documentation.
3. Coordinate with an approved testing laboratory to schedule product testing.
4. Begin compiling the comprehensive Device Master File, Plant Master File, Risk Management File, and QMS documents.
5. Identify and engage a notified body from the Notified Bodies List well in advance.
6. Upon successful product testing and documentation readiness, apply for the Manufacturing License (Form MD3) for MD5.

Taking these practical steps promptly will position your company for timely approval and successful market launch. Should you require tailored assistance, our consultancy services are just a call away to guide you through each phase with confidence.