CDSCO License for Nuclear whole body counter
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body.
Comprehensive Guide to CDSCO Licensing for Nuclear Whole Body Counter (Class A Medical Device)
As a specialized device in Interventional Radiology, the Nuclear Whole Body Counter plays a crucial role in measuring radionuclide levels in the entire body. Given its medical significance and safety considerations, obtaining the correct CDSCO license is essential for manufacturers and importers aiming to market this device in India.
With over 25 years of experience and having supported 500+ companies in successful CDSCO licensing, we bring you an expert, practical guide tailored specifically for Nuclear Whole Body Counters classified as Class A medical devices.
CDSCO Regulatory Framework for Nuclear Whole Body Counter
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017, which align devices with global safety and quality standards. The Nuclear Whole Body Counter is notified under Notification number 29/Misc./03/2020-DC (146) dated 26.07.2021, falling under the Class A risk category.
This classification mandates a State Licensing Authority-issued manufacturing license (MD5), ensuring adherence to safety, quality, and performance standards before the device enters the Indian market.
Risk Classification and License Requirements
Why Class A?
The Nuclear Whole Body Counter is categorized as Class A due to its low risk potential, primarily because it is non-invasive and functions to detect radionuclides without direct intervention inside the body.
Licensing Requirements for Class A Devices
- Manufacturing License: Form MD3 (MD5 License)
- Issuing Authority: State Licensing Authority
- Application Submission: Via CDSCO MD Online Portal
Manufacturing License Process (MD5) for Nuclear Whole Body Counter
The step-by-step process includes:
Test License Application (Form MD13): Obtain a test license that allows initial manufacturing and testing of the device. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct testing in CDSCO-approved laboratories to validate device safety and performance. Refer to the list of testing laboratories for approved facilities.
Preparation of Documentation: Compile necessary documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) records.
Application Submission (Form MD3): Submit the manufacturing license application on the CDSCO portal.
Audit by Notified Body: Engage with a notified body for an on-site audit. Select from the list of notified bodies for Class A device audits.
Resolution of Queries: Respond promptly to any departmental or notified body queries.
Grant of Manufacturing License (Form MD5): Upon satisfactory review and audit, the license is granted.
Manufacturing License Documents Required for Nuclear Whole Body Counter
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership or legal occupancy of manufacturing premises
- Technical staff qualifications and experience certificates
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, components, and specifications (Device Master File guide)
- Plant Master File (PMF) outlining manufacturing processes and quality controls (Plant Master File guide)
- Essential Principles Checklist ensuring compliance with Indian Medical Device Rules
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Nuclear Whole Body Counter
If importing the Nuclear Whole Body Counter into India, an import license (MD15) from the Central Licensing Authority is mandatory.
Process Overview:
- Document preparation including existing manufacturing license, Free Sale Certificate, CE certificate, ISO 13485:2016
- Submit application via CDSCO portal
- Address any queries from the licensing authority
- License grant within 5-6 months
For detailed guidelines, refer to our Import License Guide.
Import License Documents Required
- Valid Manufacturing License of the product
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution
Timeline and Processing Duration
| License Type | Approximate Timeline | Key Steps Included |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application, Testing, Approval |
| Manufacturing License (MD5) | 3 - 4 months total (including test license) | Document prep, audit, query resolution, license grant |
| Import License (MD15) | 5 - 6 months | Document prep, query resolution, license grant |
Government Fees and Costs
| License Type | Fee Details |
|---|---|
| MD5 Manufacturing License | Rs 5,000 per application + Rs 500 per product |
| Test License (MD13) | Included in MD5 process |
| MD15 Import License | Class A: 50 per product |
Note: Fees are subject to periodic revision; always confirm on the official CDSCO MD Online Portal.
Common Challenges and Solutions
Delayed Testing: To avoid delays, pre-book slots at CDSCO-approved labs early and ensure sample submission follows lab protocols.
Incomplete Documentation: Use comprehensive checklists and consult guides like the Device Master File guide to avoid rejection.
Audit Non-Conformities: Prepare thoroughly for notified body audits by maintaining QMS and plant documentation in audit-ready condition.
Query Management: Respond promptly and clearly to CDSCO and notified body queries to prevent processing delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for specialized devices like Nuclear Whole Body Counters. Leveraging experienced consultants accelerates approvals and ensures compliance.
Our team has successfully guided over 500 manufacturers and importers through the CDSCO licensing maze, providing end-to-end support from documentation to audit preparation. Reach out for tailored assistance to meet your regulatory goals confidently.
Getting Started with Your CDSCO License Application
Classify Your Device: Confirm your Nuclear Whole Body Counter as Class A using the Medical Device Classification resource.
Register on CDSCO Portal: Create your account at the CDSCO MD Online Portal.
Prepare Documentation: Gather all mandatory documents, focusing on the Device Master File, Plant Master File, and Risk Management File.
Apply for Test License (MD13): Initiate the process by submitting your test license application.
Schedule Laboratory Testing: Coordinate with CDSCO-approved labs to ensure timely testing.
Engage a Notified Body: Identify and book audit dates with notified bodies from the official list.
Submit MD5 Application: Once testing and documentation are complete, submit the manufacturing license application.
Respond to Queries: Maintain clear communication with CDSCO and notified bodies for efficient resolution.
Receive License and Commence Manufacturing: Upon grant, comply with ongoing post-market surveillance and regulatory requirements.
By following these steps and partnering with seasoned experts, your Nuclear Whole Body Counter can successfully enter the Indian market with full regulatory compliance.
For personalized assistance or detailed queries, feel free to contact our regulatory consultancy team.
Leverage our 25+ years of expertise and the success of 500+ clients to streamline your CDSCO licensing journey for Nuclear Whole Body Counters.
