CDSCO License for Patient Positioning System, Ultrasound

Comprehensive Guide to CDSCO Licensing for Patient Positioning System, Ultrasound (Class C)

Navigating the regulatory landscape for medical devices in India requires precision, expertise, and up-to-date knowledge. As specialists with over 25 years of experience assisting 500+ companies, we bring you an authoritative guide to securing your CDSCO license for the Patient Positioning System, Ultrasound—a Class C radiotherapy device. This critical device aids in precise external beam radiation treatment by using ultrasound imaging and sophisticated tracking software, making regulatory compliance paramount for patient safety and market access.

CDSCO Regulatory Framework for Patient Positioning Systems in Radiotherapy

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. For devices like the Patient Positioning System, which falls under radiotherapy and uses advanced ultrasound imaging for treatment accuracy, strict adherence to the CDSCO regulations ensures safety, quality, and efficacy.

The device is classified under Class C risk category due to its direct role in patient treatment and potential impact on health outcomes. Consequently, it demands a manufacturing license under the MD9 category granted by the Central Licensing Authority.

Risk Classification and License Requirements for Class C Devices

According to the CDSCO classification system, Class C devices are medium-to-high risk and require thorough evaluation before approval. This classification mandates:

• Manufacturing License: Application via Form MD7 for MD9 license
• Import License: Application via Form MD14 for MD15 license
• Test License: Often required initially via Form MD13

For detailed classification criteria, consult our Medical Device Classification resource.

Manufacturing License Process for Patient Positioning System (MD9 License)

The manufacturing license process for Class C devices is centralized and typically takes 4 to 5 months. Here’s a step-by-step breakdown:

1. Test License (Form MD13): This preliminary license is mandatory and takes approximately 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved government laboratories. Refer to the list of testing laboratories for approved facilities.
3. Document Preparation: Assemble comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Apply through the CDSCO MD Online Portal using Form MD7.
5. Audit by CDSCO Inspectors: Post-application, an audit inspects manufacturing premises and processes.
6. Query Resolution: Address any observations or queries raised during the audit.
7. License Grant: Upon successful completion, the MD9 manufacturing license is issued.

For an in-depth walkthrough, see our MD9 License Guide.

Manufacturing License Documents Required

Accurate and complete documentation is critical to avoid delays. For your Patient Positioning System, ensure you have:

• Company Constitution and ownership proof of manufacturing premises
• Technical staff credentials (qualification and experience)
• Fire Safety NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications and design (Device Master File guide)
• Plant Master File (PMF) outlining manufacturing infrastructure (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File following ISO 14971 guidelines (Risk Management resource)
• Product Test Reports from CDSCO-approved labs
• Device labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process for Patient Positioning System (MD15 License)

If you plan to import the Patient Positioning System into India, the MD15 import license process, governed by the Central Licensing Authority, typically takes 5 to 6 months. The key steps include:

1. Document Preparation: Compile all necessary certificates including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
2. Application Submission: File your application on the CDSCO MD Online Portal using Form MD14.
3. Evaluation and Queries: CDSCO reviews documents and may raise queries.
4. License Grant: After satisfactory response, the MD15 import license is issued.

Detailed guidance is available in our Import License Guide.

Import License Documents Required

For Class C imports, prepare the following:

• Valid Manufacturing License from the manufacturing country
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent regulatory approvals
• Device Master File and Plant Master File
• Wholesale license (if applicable)
• Company Constitution and ownership proof

Timeline and Processing Duration

Government Fees and Costs

For your Class C Patient Positioning System, fees are as follows:

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• Test License (MD13): Applicable fees as per CDSCO norms
• MD15 Import License: $3,000 per site +$1,500 per product

Budgeting for these fees early helps avoid surprises during the application process.

Common Challenges and Solutions

Challenge: Delays in obtaining test reports from government-approved labs.

Solution: Engage early with certified labs listed on the CDSCO Testing Laboratories page and schedule tests well in advance.

Challenge: Incomplete or inconsistent documentation leading to audit observations.

Solution: Utilize comprehensive checklists and consult our Device Master File and Plant Master File guides to ensure thorough documentation.

Challenge: Complex queries from CDSCO during review.

Solution: Prepare detailed, evidence-backed responses and seek expert regulatory support to minimize back-and-forth.

Expert Consultation and Support

With 25+ years of regulatory consulting and over 500 successful CDSCO license applications, we offer tailored assistance including:

• Gap analysis and compliance roadmap
• Document preparation and review
• Liaison with CDSCO authorities and notified bodies
• Post-approval support and renewals

Our expertise can significantly reduce your approval timelines and enhance compliance confidence.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your Patient Positioning System falls under Class C using official CDSCO guidelines.
2. Prepare Documentation: Begin compiling the Device Master File, Risk Management File, and QMS documents.
3. Engage Testing Labs: Contact government-approved labs early to schedule product testing.
4. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
5. Plan for Audit: Prepare your manufacturing facility and processes for the CDSCO inspection.
6. Consult Experts: Leverage our proven expertise to guide you through each step.

Starting early and following a structured approach is key to successfully launching your Patient Positioning System in India’s regulated medical device market. Reach out to us to streamline your CDSCO licensing journey and gain timely market access.