CDSCO License for Patient positioning device for extremity diagnostic imaging and  radiotherapy

Comprehensive Guide to CDSCO Licensing for Patient Positioning Devices in Radiotherapy

Patient positioning devices for extremity diagnostic imaging and radiotherapy are critical medical devices designed to precisely position and immobilize patients’ arms and legs during diagnostic imaging, image-guided surgeries, interventional therapies, and radiotherapy. Their use enhances the accuracy of treatment delivery and diagnostic outcomes, making regulatory compliance essential for manufacturers and importers targeting the Indian market.

With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we provide expert guidance on navigating the regulatory framework for this Class B radiotherapy device.

CDSCO Regulatory Framework for Patient Positioning Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India under the Ministry of Health and Family Welfare. For patient positioning devices classified as Class B (low moderate risk), the regulatory pathway involves obtaining an MD5 manufacturing license if manufacturing locally or an MD15 import license if importing.

The governing notification is File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, which specifically includes devices used in radiotherapy.

Manufacturers must comply with the Medical Device Rules, 2017 and submit applications via the CDSCO MD Online Portal.

Risk Classification and License Requirements for Class B Devices

Patient positioning devices fall under Class B risk classification due to their moderate impact on patient safety and performance. This classification mandates:

• MD5 Manufacturing License (Application Form MD3)
• License granted by the State Licensing Authority
• Compliance with quality management systems (ISO 13485:2016)
• Submission of detailed technical and safety documentation

For importers, the applicable license is the MD15 import license, granted by the Central Licensing Authority.

Learn more about Medical Device Classification for detailed categorization.

Manufacturing License Process (MD5) for Class B Patient Positioning Devices

The MD5 license process typically takes 3 to 4 months and involves several key steps:

1. Test License Application (Form MD13): Obtain a test license valid for 3-6 months to conduct product testing.
2. Testing at Government-Approved Labs: Submit samples to CDSCO-recognized labs for performance and safety testing. Find the list of approved Testing Laboratories.
3. Document Preparation: Compile comprehensive technical files, including Device Master File and Plant Master File.
4. License Application (Form MD3): Submit MD5 manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for a mandatory quality system audit. Review the Notified Bodies List for MD5 Audit.
6. Query Resolution: Address any queries or clarifications raised by CDSCO or notified bodies promptly.
7. License Grant: Upon satisfactory review and audit, CDSCO issues the MD5 license.

Manufacturing License Documents Required for Patient Positioning Devices

Documentation is critical. The following are essential:

• Company constitution and registration proof
• Proof of premises ownership or lease
• Details and qualifications of the technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File outlining risk assessment and mitigation strategies (Risk Management)
• Test Reports from approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process (MD15) for Patient Positioning Devices

For importers, the MD15 license is mandatory, with a typical timeline of 5 to 6 months. The process includes:

1. Document Preparation: Compile necessary certificates and files.
2. Application Submission (Form MD14): File MD15 license application on the CDSCO MD Online Portal.
3. Query Resolution: Promptly respond to CDSCO queries.
4. License Grant: CDSCO issues the import license.

No test license is required for imports.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent international approvals
• Device and Plant Master Files
• Wholesale license for distribution
• Company constitution and registration certificates

Timeline and Processing Duration

Total: Approximately 3 to 4 months for MD5 manufacturing license.

For import license (MD15), expect around 5 to 6 months due to the centralized process.

Government Fees and Costs

• MD5 License:
  • Rs 5,000 per application
  • Rs 500 per product
• MD15 Import License (Class B):
  • Approximately Rs 1,60,000 per site (USD 2000 approx)
  • Rs 80,000 per product (USD 1000 approx)

Note: Fees are subject to change; always verify current fee schedules on the CDSCO portal.

Common Challenges and Solutions

Challenge 1: Document Completeness and Accuracy

• Solution: Maintain a robust document control system and use expert templates for Device and Plant Master Files.

Challenge 2: Delays in Product Testing

• Solution: Engage with approved testing labs early and confirm their current workload.

Challenge 3: Audit Non-compliance

• Solution: Conduct pre-audit internal assessments and ensure QMS compliance before notified body visits.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with clear, evidence-backed explanations.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for Class B radiotherapy devices with stringent quality and safety expectations. Our 25+ years of consulting experience include:

• Preparing flawless applications
• Coordinating with testing labs and notified bodies
• Streamlining audit preparations
• Providing tailored regulatory strategies

We ensure you avoid common pitfalls and expedite your time-to-market in India.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Use the Medical Device Classification tool to validate your device’s risk class.
2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
3. Apply for Test License (MD13): Initiate your test license application to start product testing.
4. Engage Testing Labs and Notified Bodies Early: Contact labs listed on the portal and select a notified body for audit.
5. Prepare Device and Plant Master Files: Refer to our detailed guides to compile comprehensive files.
6. Develop QMS and Risk Management Files: Implement ISO 13485:2016 and risk management per international standards.
7. Submit MD5 License Application (Form MD3): After testing, submit your manufacturing license application.
8. Prepare for Audit: Conduct internal audits and readiness assessments.
9. Resolve Queries Promptly: Assign a dedicated team to handle queries efficiently.

Embarking on this journey with expert support ensures compliance and smooth licensing for your patient positioning device in India’s radiotherapy market. Contact us today to leverage our proven track record and accelerate your CDSCO licensing success.