CDSCO License for Nuclear whole body scanner

Comprehensive Guide to CDSCO Licensing for Nuclear Whole Body Scanner (Class A Medical Device)

At our consultancy, with over 25 years of regulatory expertise and having successfully guided 500+ medical device companies, we understand the nuances of obtaining CDSCO licenses for complex devices like the Nuclear Whole Body Scanner. This device, classified as Class A under Indian regulations, falls within the Interventional Radiology category and requires meticulous compliance with CDSCO norms to ensure timely market entry.

Understanding the Nuclear Whole Body Scanner and Its Regulatory Importance

A Nuclear Whole Body Scanner is designed to image and quantify the distribution of radionuclides across the entire body using a wide-aperture detector moving relative to the patient. Given its application in nuclear medicine and diagnostic imaging, regulatory oversight ensures safety, efficacy, and quality assurance before it reaches Indian patients and healthcare providers.

The device is notified under notification number 29/Misc./03/2020-DC (146), dated 26.07.2021, emphasizing its regulated status by the Central Drugs Standard Control Organization (CDSCO).

CDSCO Regulatory Framework for Nuclear Whole Body Scanner

As a Class A device, the Nuclear Whole Body Scanner is considered low risk. However, it still requires a structured regulatory pathway primarily governed by the State Licensing Authority via the MD5 license process under the Medical Device Rules, 2017.

Manufacturers must demonstrate compliance with essential principles, quality management systems, and technical documentation to ensure product safety and performance.

Risk Classification and License Requirements for Class A Devices

According to the Medical Device Rules and the Medical Device Classification guide, Class A devices include low-risk devices like the Nuclear Whole Body Scanner. For these, the mandatory licensing process involves obtaining the MD5 manufacturing license (Form MD3) from the State Licensing Authority.

Additionally, a test license (Form MD13) must be obtained initially to conduct product testing at government-approved laboratories.

Manufacturing License Process (MD5) for Nuclear Whole Body Scanner

The MD5 license issuance follows a multi-step process:

1. Test License Application (Form MD13): The first step is applying for a test license, allowing testing of the Nuclear Whole Body Scanner at CDSCO-recognized labs.

2. Product Testing: Testing must be conducted in notified laboratories listed on the CDSCO Testing Laboratories page. This ensures the device meets safety and performance standards.

3. Preparation of Technical Documentation: Post-testing, prepare comprehensive documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

4. Application for MD5 License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal to the State Licensing Authority.

5. Audit by Notified Body: An on-site audit by a notified body (refer to the List of Notified Bodies) will assess compliance with manufacturing and quality standards.

6. Queries Resolution: Address any queries or observations raised by the CDSCO or notified body promptly.

7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license, allowing manufacturing of the Nuclear Whole Body Scanner in India.

Manufacturing License Documents Required for MD5

• Company Constitution documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical personnel
• Fire and Pollution NOCs
• Device Master File (technical specifications and design details) – see our detailed Device Master File guide
• Plant Master File describing manufacturing facilities – learn how to prepare it in our Plant Master File guide
• Essential Principles Checklist for compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation – refer to our Risk Management resource
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certification recommended)

Import License Process (MD15) for Nuclear Whole Body Scanner

If you are an importer intending to bring the Nuclear Whole Body Scanner into India, the MD15 import license must be obtained from the Central Licensing Authority.

Key steps include:

• Preparing comprehensive documentation including existing manufacturing licenses, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate if applicable, Device and Plant Master Files, wholesale license, and company constitution.
• Application submission on the CDSCO MD Online Portal.
• Addressing any queries from CDSCO and subsequent grant of the MD15 license.

The import license process typically takes 5-6 months due to the thorough review of technical and quality documentation.

Import License Documents Required

• Manufacturing License of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution
• Company Constitution documents

Timeline and Processing Duration

Overall, expect the entire manufacturing license process to take about 3-4 months from test license application to final grant. Import licenses (MD15) take slightly longer, approximately 5-6 months.

Government Fees and Costs

• Test License (MD13): No separate fee mentioned but included in overall process
• MD5 Manufacturing License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

For a Nuclear Whole Body Scanner, assuming a single product application, the total fees approximate Rs 5,500.

Additional costs include product testing fees charged by notified laboratories, audit fees payable to notified bodies, and consultancy fees if applicable.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Engage with multiple CDSCO-approved testing laboratories early. Refer to the Testing Laboratories list to select labs with shorter lead times.

Challenge: Incomplete documentation leading to queries and rejections.

Solution: Use our comprehensive checklists and expert review to ensure all documents like Device Master File and Risk Management File are meticulously prepared.

Challenge: Audit non-compliance due to gaps in manufacturing practices.

Solution: Conduct internal mock audits and gap assessments before notified body audits to ensure readiness.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we provide end-to-end support—from initial device classification and documentation preparation to test license applications, coordination with notified bodies, and final license grant.

Our experts stay updated with CDSCO's latest regulatory updates and can streamline your Nuclear Whole Body Scanner's licensing process.

Getting Started with Your CDSCO License Application

1. Device Classification Confirmation: Verify your device's risk class and applicable notification.
2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to commence testing.
3. Select Testing Laboratory: Choose an appropriate CDSCO-approved lab to ensure timely testing.
4. Prepare Technical Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documentation.
5. Schedule Notified Body Audit: Identify and engage a notified body early by reviewing the Notified Bodies List.
6. Submit MD5 License Application: Once test reports and audit clearance are in place, apply for the manufacturing license.
7. Respond to Queries Promptly: Maintain proactive communication with CDSCO.

Embarking on this process with a structured approach and expert guidance will significantly enhance your chances of smooth and timely licensing.

For personalized assistance and to leverage our deep regulatory expertise, contact us today to get your Nuclear Whole Body Scanner CDSCO licensing underway.