CDSCO License for Non-powered neutron therapy table

Introduction to Non-powered Neutron Therapy Table and Regulatory Importance

Non-powered neutron therapy tables are specialized medical devices designed to facilitate precise patient positioning and immobilization during neutron radiotherapy treatments. These tables are essential in ensuring accurate delivery of neutron rays generated from nuclear reactors, enhancing treatment efficacy and patient safety. Given the critical role these devices play in radiotherapy, obtaining the appropriate CDSCO licensing in India is mandatory to ensure compliance with national safety and quality standards.

As experienced regulatory consultants with over 25 years in the Indian medical device sector and having successfully guided more than 500 companies through the CDSCO licensing maze, we understand the nuances involved in securing licenses for Class A devices like the non-powered neutron therapy table.

CDSCO Regulatory Framework for Non-powered Neutron Therapy Tables

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). The non-powered neutron therapy table falls under the radiotherapy category and is classified as a Class A medical device due to its relatively low risk profile.

Class A devices are governed primarily by State Licensing Authorities, requiring manufacturers or importers to obtain an MD5 license (Manufacturing License for Class A and B devices). This regulatory oversight ensures that devices meet essential safety, efficacy, and quality benchmarks before entering the Indian market.

Risk Classification and License Requirements for Class A Devices

The CDSCO classifies medical devices into four risk classes (A, B, C, D) based on intended use and potential risk to the patient. The non-powered neutron therapy table is Class A, indicating low risk.

For Class A devices:

• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3
• Process Duration: Approximately 3-4 months (including test license, product testing, audit)
• Government Fees: ₹5,000 per application + ₹500 per product

This classification necessitates compliance with documentation, testing, and audit procedures tailored to Class A devices.

Step-by-Step Manufacturing License Process (MD5) for Non-powered Neutron Therapy Tables

1. Obtain Test License (Form MD13):
   • Duration: 1.5 to 2 months
   • Purpose: To carry out required product testing in government-approved laboratories.
2. Product Testing:
   • Conduct tests at accredited labs listed on the CDSCO Testing Laboratories Portal.
   • Tests validate safety features such as mechanical stability, pneumatic controls, and locking mechanisms.
3. Documentation Preparation:
   • Compile comprehensive documents including Device Master File and Plant Master File.
   • Prepare Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission:
   • Submit the manufacturing license application via the CDSCO MD Online Portal.
   • Use Application Form MD3 for the MD5 license.
5. Audit by Notified Body:
   • Engage a notified body from the CDSCO List of Notified Bodies for onsite audit.
6. Resolution of Queries:
   • Address any observations raised by the licensing authority or notified body promptly.
7. Grant of MD5 Manufacturing License:
   • Upon satisfactory compliance, the license is issued on Form MD5.

Manufacturing License Documents Required

For the non-powered neutron therapy table, the following documents must be prepared meticulously:

• Company Constitution Documents: Proof of ownership, partnership deeds, or incorporation certificates.
• Proof of Premises Ownership or Lease Agreement: Valid documents showing the manufacturing site.
• Technical Staff Details: Qualification and experience certificates of technical and quality personnel.
• No Objection Certificates (NOCs): Fire safety and pollution control clearances.
• Device Master File (DMF): Detailed device specifications, design, manufacturing process, and quality control.
• Plant Master File (PMF): Infrastructure, equipment, and production processes at the manufacturing site.
• Essential Principles of Safety and Performance Checklist: Compliance matrix with MDR requirements.
• Risk Management File: Analysis and mitigation strategies per medical device risk management guidelines.
• Test Reports: From government-approved labs validating device performance.
• Product Labels and Instructions for Use (IFU): As per regulatory standards.
• Quality Management System (QMS) Documentation: Procedures, work instructions, and records ensuring consistent quality.

Our detailed Device Master File guide and Plant Master File guide offer practical templates and checklists to streamline documentation.

Import License Process (MD15) for Non-powered Neutron Therapy Tables

For importers, the relevant license is MD15 granted by the Central Licensing Authority. However, since the non-powered neutron therapy table is a Class A device, most manufacturers opt for in-country manufacturing with an MD5 license.

If importing, the process involves:

• Preparing and submitting Form MD14 for MD15 license application.
• Providing documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), and detailed device and plant master files.

The process can take 5-6 months, with fees varying based on device class. For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration

For manufacturers of non-powered neutron therapy tables (Class A):

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• Document Preparation: 1 month (can overlap with testing)
• Application Submission and Audit: 1 to 1.5 months
• Queries Resolution and License Grant: 2 to 3 weeks

Total Duration: Approximately 3 to 4 months from test license application to license grant.

Government Fees and Costs

• Test License (MD13): Fees vary by State; typically ₹5,000 to ₹10,000
• MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
• Testing Fees: Depend on laboratory and number of tests; budget approximately ₹50,000 to ₹1,00,000
• Audit Fees: Charged by notified body; varies, generally ₹50,000 to ₹1,00,000

Budgeting for these costs upfront prevents delays and ensures smoother regulatory compliance.

Common Challenges and Practical Solutions

• Delays in Product Testing: Engage with government-approved testing laboratories early and submit samples promptly.
• Incomplete Documentation: Use comprehensive checklists and templates to ensure all documents meet CDSCO requirements.
• Audit Non-conformities: Prepare your quality system and manufacturing site in line with notified body expectations; conduct internal audits beforehand.
• Resolving Queries: Respond to CDSCO queries with clear, concise, and evidence-backed information to avoid prolonged back-and-forth.

Our team’s experience helping 500+ companies means we anticipate these pain points and provide tailored strategies to overcome them efficiently.

Expert Consultation and Support

Navigating CDSCO licensing for radiotherapy devices like the non-powered neutron therapy table requires expert insight. We offer end-to-end support including:

• Gap analysis of your current compliance status
• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application drafting and submission on the CDSCO MD Online Portal
• Post-license regulatory support and renewals

Partnering with seasoned consultants accelerates approval timelines and minimizes costly errors.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm Class A status via the Medical Device Classification resource.
2. Prepare Documentation: Begin compiling the Device Master File and Plant Master File using our guides.
3. Apply for Test License: File Form MD13 through the CDSCO portal to initiate product testing.
4. Engage Testing Labs: Coordinate sample testing immediately after test license approval.
5. Schedule Audit: Select a notified body from the official Notified Bodies List and prepare for the onsite audit.
6. Submit MD5 Application: After testing and audit, submit your license application via Form MD3.

Taking these actionable steps with expert guidance will position your non-powered neutron therapy table for successful market entry in India.

For tailored assistance, connect with our regulatory experts today and leverage our 25+ years of CDSCO licensing expertise to streamline your medical device approval journey.