CDSCO License for Brachytherapy radionuclide phantom,  test object

Comprehensive Guide to CDSCO Licensing for Brachytherapy Radionuclide Phantom (Class A Medical Device)

As experienced regulatory consultants with over 25 years and a track record of assisting 500+ companies, we understand the critical importance of securing your CDSCO manufacturing or import license efficiently. This guide focuses specifically on the Brachytherapy radionuclide phantom test object, a Class A oncology device used in radiation therapy performance evaluations, and outlines the full regulatory pathway, timelines, costs, and documentation you need for compliance.

CDSCO Regulatory Framework for Brachytherapy Radionuclide Phantom

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. The device in question, classified as Class A (low risk), falls under state jurisdiction for manufacturing licenses but central authority for import licenses. The device is notified under File No. 29/Misc./03/2020-DC (153) — Part 1 dated 11.10.2022, confirming its regulatory classification and requirements.

Risk Classification and License Requirements for Class A Devices

Class A medical devices, like the brachytherapy radionuclide phantom, are considered low risk and require an MD5 manufacturing license or MD15 import license before marketing or manufacturing in India. Here's what you need to know:

• Manufacturing License: MD5 license issued by the State Licensing Authority
• Application Form: MD3 for manufacturing
• Timeline: Approximately 3-4 months from test license to final approval
• Import License: MD15 license issued by the Central Licensing Authority
• Timeline: 5-6 months

For more details on classification, see our Medical Device Classification guide.

Manufacturing License Process (MD5) for Brachytherapy Radionuclide Phantom

1. Obtain Test License (Form MD13): This preliminary license allows product testing and takes about 1.5 to 2 months.
2. Product Testing: Conduct tests in CDSCO-approved government laboratories to validate safety and performance. Find a list of Testing Laboratories on the CDSCO portal.
3. Document Preparation: Compile technical and quality management documentation.
4. Submit Application (Form MD3): File your MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for audit services. Refer to the Notified Bodies List for authorized agencies.
6. Respond to Queries: Address any clarifications requested by CDSCO or the notified body promptly.
7. License Grant (Form MD5): Upon satisfactory evaluation, the license is issued.

Manufacturing License Documents Required

To ensure a smooth approval process, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Facility details, quality control measures, and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulatory standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
• Test Reports from Government Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably compliant with ISO 13485:2016

Import License Process (MD15) for Brachytherapy Radionuclide Phantom

For importers wishing to bring this Class A device into India, the MD15 license is mandatory. The process includes:

• Document preparation as per CDSCO requirements
• Submission of Form MD14 via the CDSCO MD Online Portal
• Resolution of any departmental queries
• Final grant of license on Form MD15

Unlike manufacturing, no test license is required, but you must provide certificates such as Free Sale Certificate, ISO 13485:2016, CE Certificate, and a valid manufacturing license from the country of origin.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

For the MD5 manufacturing license (Class A devices):

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

For the MD15 import license (Class A devices):

• Site Fee: $1,000 (approx. Rs. 75,000)
• Product Fee: $50 (approx. Rs. 3,750) per product

Note the fees are subject to change; always confirm on the CDSCO portal.

Common Challenges and Practical Solutions

• Delayed Test Reports: To avoid bottlenecks, pre-select government-approved labs and schedule tests early.
• Incomplete Documentation: Use detailed checklists for Device Master File and Plant Master File preparation.
• Audit Non-compliance: Conduct internal mock audits and rectify gaps before notified body visits.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to CDSCO queries.

Our long-standing experience has shown that proactive planning and early engagement with notified bodies and testing labs smoothen the process significantly.

Expert Consultation and Support

Navigating CDSCO regulations for specialized devices like the brachytherapy radionuclide phantom requires expert knowledge. We offer end-to-end consultancy services including:

• Gap analysis and documentation support
• Application preparation and submission
• Coordination with notified bodies and testing laboratories
• Post-approval compliance and vigilance

Our proven methodology has helped numerous manufacturers and importers reduce approval timelines and avoid costly rejections.

Getting Started with Your CDSCO License Application

1. Identify License Type: Confirm if you require an MD5 manufacturing license or MD15 import license.
2. Prepare Documentation: Begin compiling all required documents, focusing on Device and Plant Master Files.
3. Plan Product Testing: Contact government-approved testing labs early to schedule tests.
4. Engage Notified Body: For MD5, select a notified body for audit; consult the Notified Bodies List.
5. Submit Online Application: Use the CDSCO MD Online Portal for all submissions.
6. Track and Respond: Monitor application status and address any queries promptly.

By following these strategic steps and leveraging our expertise, you can confidently enter the Indian market with your brachytherapy radionuclide phantom device, ensuring compliance and timely market access.

For a detailed walkthrough of the MD5 license process, visit our MD5 License Guide.

We invite you to reach out for personalized consultation to streamline your CDSCO licensing journey and safeguard your product’s regulatory compliance.