CDSCO License for Powered radiation therapy patient support assembly

Comprehensive Guide to CDSCO Licensing for Powered Radiation Therapy Patient Support Assembly (Class C Device)

When it comes to advanced medical equipment like a powered radiation therapy patient support assembly, regulatory compliance is paramount. This electrically powered adjustable couch plays a critical role in supporting patients during radiation therapy, making its safety and efficacy essential. As a Class C medical device under the CDSCO framework, manufacturers and importers must navigate a rigorous licensing process to legally market this device in India.

With over 25 years of experience and having successfully guided more than 500 companies through the CDSCO licensing maze, we provide you with a practical, detailed roadmap tailored specifically for this device category.

CDSCO Regulatory Framework for Powered Radiation Therapy Patient Support Assembly

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Your powered radiation therapy patient support assembly is categorized under radiotherapy devices and classified as Class C, which involves a moderate to high risk profile due to its direct use in therapeutic procedures.

The key regulatory requirement for manufacturing this device is obtaining an MD9 license from the Central Licensing Authority. For importers, the MD15 import license is mandatory. These licenses ensure that your device meets the Indian Essential Principles, quality standards, and safety requirements.

For official notification and classification details, refer to the government notification File No. 29/Misc./03/2020-DC (180), dated 6.8.2021.

Risk Classification and License Requirements for Class C Devices

India classifies medical devices from Class A (low risk) to Class D (high risk). Your powered radiation therapy patient support assembly falls under Class C due to its involvement in critical patient support during radiation treatment.

• Class C Devices: Require an MD9 manufacturing license granted by the Central Licensing Authority.
• Application Form: MD7 for MD9 license.
• Import License: MD15 from Central Licensing Authority.

The MD9 license process is comprehensive, involving a test license, product testing in government-approved labs, document submission, audits, and final approval.

For detailed classification info, you can visit our Medical Device Classification guide.

Manufacturing License Process (MD9) for Powered Radiation Therapy Patient Support Assembly

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, you must secure a test license under Form MD13. This license authorizes you to manufacture the device for testing purposes.

• Timeline: Approximately 1.5 to 2 months.
• Purpose: To facilitate product testing and compliance verification.

Step 2: Product Testing at CDSCO-Approved Laboratories

Once the test license is granted, the device must undergo rigorous testing in government-approved labs. Testing ensures adherence to Essential Principles and safety standards.

• Visit the list of CDSCO-approved testing laboratories to select an appropriate facility.
• Testing duration varies depending on laboratory capacity but typically takes 1 to 2 months.

Step 3: Documentation Preparation

Prepare your complete dossier including technical, quality, and safety documentation.

Step 4: Application Submission for MD9 License (Form MD7)

Submit your application for the MD9 manufacturing license through the CDSCO MD Online Portal.

Step 5: CDSCO Audit and Inspection

CDSCO inspectors will conduct an onsite audit of your manufacturing facility to verify compliance with regulatory standards and Good Manufacturing Practices (GMP).

Step 6: Query Resolution

Respond promptly to any queries or observations raised by the CDSCO or auditors.

Step 7: License Grant

Upon satisfactory compliance, CDSCO issues the MD9 license (Form MD9), authorizing manufacturing of your powered radiation therapy patient support assembly in India.

Manufacturing License Documents Required for MD9 Application

Successful MD9 license applications for Class C devices require comprehensive documentation:

• Company Constitution: Incorporation documents, Memorandum & Articles of Association.
• Proof of Premises Ownership or Lease: Valid ownership or rental agreements.
• Technical Staff Details: Qualifications and experience of key personnel.
• Fire NOC & Pollution NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. Our Device Master File guide offers a step-by-step framework.
• Plant Master File (PMF): Description of manufacturing facilities and GMP compliance. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with CDSCO Essential Principles.
• Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about implementing medical device risk management.
• Test Reports: From CDSCO-approved laboratories.
• Labels and Instructions for Use (IFU): Compliant with Indian regulations.
• Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification and SOPs.

Ensuring meticulous preparation of these documents expedites your application.

Import License Process (MD15) for Powered Radiation Therapy Patient Support Assembly

If you intend to import the powered radiation therapy patient support assembly, an MD15 import license is mandatory.

Application Process:

• No test license required unlike manufacturing.
• Prepare a dossier including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master files, wholesale license, and company constitution.
• Submit the application using Form MD14 on the CDSCO MD Online Portal.
• CDSCO evaluates your documents, may raise queries, and upon satisfaction, grants the MD15 license.

Fees:

• For Class C devices, the government fees are approximately $3000 per site and$1500 per product.

For a detailed step-by-step approach, consult our Import License Guide.

Timeline and Processing Duration

Total Time: Approximately 4 to 5 months for MD9 manufacturing license for Class C devices.

Import licenses (MD15) generally take 5 to 6 months given the thorough document review process.

Government Fees and Costs

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product.
• Test License (MD13): Included in application fees.
• Import License (MD15): $3,000 per site +$1,500 per product (Class C devices).

Budgeting for these fees upfront prevents delays.

Common Challenges and Practical Solutions

Challenge 1: Lengthy Testing Timelines

• Solution: Engage with CDSCO-approved testing labs early. Some labs may offer expedited testing for an additional fee.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and templates for Device and Plant Master Files. Our guides provide practical templates and examples.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal pre-audits to identify gaps. Maintain meticulous records of QMS and GMP practices.

Challenge 4: Delayed Query Responses

• Solution: Allocate dedicated regulatory personnel to monitor and respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape can be complex, especially for Class C devices like powered radiation therapy patient support assemblies. Our seasoned regulatory consultants have helped over 500 companies successfully obtain their licenses by offering:

• Tailored regulatory strategy and gap analysis.
• Comprehensive dossier preparation and review.
• Liaising with CDSCO officials and notified bodies.
• Internal audit and compliance training.

Reach out to us early in your regulatory journey to minimize risks and shorten approval timelines.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status using the Medical Device Classification tool.
2. Prepare Test License Application (Form MD13): Gather documentation and apply via the CDSCO MD Online Portal.
3. Engage CDSCO-Approved Testing Labs: Schedule product testing post test license approval.
4. Compile Complete Documentation: Use our Device Master File and Plant Master File guides.
5. Submit MD9 Application (Form MD7): Upload documents through the online portal.
6. Prepare for Audit: Conduct internal audits and training.
7. Respond to CDSCO Queries Promptly: Ensure smooth progression.

By following these actionable steps and leveraging expert guidance, you can successfully bring your powered radiation therapy patient support assembly to the Indian market with full CDSCO compliance.

For personalized assistance, connect with our regulatory experts today and streamline your licensing journey.