CDSCO License for Nuclear sealed  calibration source

Introduction to Nuclear Sealed Calibration Source and Regulatory Importance

A Nuclear Sealed Calibration Source is a specialized device comprising an encapsulated reference radionuclide used primarily for calibrating medical nuclear radiation detectors. This device plays a critical role in ensuring accurate diagnostics and safety in interventional radiology procedures. Given its radioactive content and medical application, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is essential to guarantee safety, efficacy, and compliance with Indian medical device regulations.

At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the nuances of navigating the CDSCO licensing landscape for such sensitive devices. This guide details the step-by-step process to obtain the necessary licenses, focusing specifically on the Class A risk classification applicable to Nuclear Sealed Calibration Sources.

CDSCO Regulatory Framework for Nuclear Sealed Calibration Source

Under the Medical Device Rules (MDR) 2017, as amended by CDSCO notifications, Nuclear Sealed Calibration Sources are classified as Class A medical devices due to their low risk profile but specialized use. The notification 29/Misc./03/2020-DC (146), dated 26.07.2021, includes these devices under the category of Interventional Radiology.

As per CDSCO, manufacturing of Class A devices requires an MD5 license issued by the State Licensing Authority. Importers also need to comply with CDSCO import regulations if sourcing these devices internationally.

Risk Classification and License Requirements

• Device Name: Nuclear Sealed Calibration Source
• Risk Class: A (Low Risk)
• Regulatory License: MD5 Manufacturing License (Form MD3 application)
• Authority: State Licensing Authority (for manufacturing)
• Test License: Required initially (Form MD13)

Class A devices like this require a structured approval process involving initial test license issuance, product testing, documentation review, and an audit by a notified body.

Manufacturing License Process (MD5)

1. Obtain Test License (Form MD13):

   • Submit application for test license to manufacture and test the product.
   • Duration: Approximately 1.5 to 2 months.

2. Product Testing:

   • Carry out product testing at CDSCO-recognized laboratories to validate safety and compliance.
   • Use the list of Testing Laboratories approved by CDSCO.

3. Document Preparation:

   • Compile required documentation including Device Master File, Plant Master File, Quality Management System (QMS) documentation, and risk management files.

4. Apply for MD5 Manufacturing License (Form MD3):

   • Submit the complete application along with supporting documents on the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • Arrange for a conformity assessment audit from a CDSCO notified body.
   • Review the Notified Bodies List for MD5 Audit to select an auditor.

6. Resolution of Queries:

   • Address any queries raised by the State Licensing Authority or the notified body promptly.

7. Grant of MD5 License:

   • Upon satisfactory compliance, the State Licensing Authority grants the manufacturing license (Form MD5).

The entire process typically spans 3 to 4 months.

Manufacturing License Documents Required

The documentation package for a Nuclear Sealed Calibration Source manufacturing license includes but is not limited to:

• Company Constitution Documents (Incorporation Certificate, Memorandum of Association, etc.)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File detailing design and specifications (Device Master File Guide)
• Plant Master File outlining manufacturing environment and processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (typically ISO 13485 compliant)

Ensuring all these documents are accurate and up-to-date reduces processing delays significantly.

Import License Process (MD15)

Though your device is Class A and manufacturing requires an MD5 license, if you plan to import Nuclear Sealed Calibration Sources, an MD15 import license from CDSCO’s Central Licensing Authority is mandatory.

Key steps include:

• Preparing required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and Device and Plant Master Files.
• Applying online via the CDSCO MD Online Portal.
• Responding promptly to any CDSCO queries.
• Awaiting grant of MD15 license, which typically takes 5 to 6 months.

Refer to our detailed Import License Guide for streamlined application support.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution Documents

Fees vary depending on device classification and number of products.

Timeline and Processing Duration

The timelines assume timely submission of complete documents and prompt response to regulatory queries.

Government Fees and Costs

For a Class A device like the Nuclear Sealed Calibration Source:

• MD5 Manufacturing License Fees:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD13 Test License Fee:

  • Included within the application fees; confirm exact fees during application.

• MD15 Import License Fees:

  • For Class A: Approximately $1,000 per site and$50 per product.

Additional costs include fees for notified body audits and product testing, which vary depending on the selected service provider.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents are the leading cause of application delays. Meticulously cross-check each document against CDSCO requirements.

• Delayed Product Testing: Coordinate early with CDSCO-approved testing labs to schedule tests and obtain timely reports.

• Audit Non-Compliance: Prepare for notified body audits through internal pre-audit checks and staff training.

• Regulatory Query Responses: Assign dedicated personnel to monitor application status and respond swiftly.

• Complex Import Documentation: Importers should maintain comprehensive records, including compliance certificates, to avoid customs clearance issues.

Our proven methodology includes pre-submission audits and proactive query management to mitigate these pain points.

Expert Consultation and Support

Navigating CDSCO licensing for nuclear sealed calibration sources involves technical, regulatory, and safety expertise. Our consultancy offers tailored support including:

• Document preparation aligned with CDSCO expectations
• Coordination with notified bodies and testing laboratories
• Application submission and follow-up on the CDSCO MD Online Portal
• Training on regulatory compliance and audit readiness

Our track record with 500+ successful CDSCO licenses underscores our ability to facilitate smooth approvals.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class A per the latest Medical Device Classification.

2. Initiate Test License Application: Prepare and submit Form MD13 for the test license via the CDSCO portal.

3. Select Testing Laboratory: Choose a CDSCO-recognized lab early (Testing Laboratories List) to avoid delays.

4. Compile Comprehensive Documentation: Utilize our Device Master File Guide and Plant Master File Guide to prepare your dossiers.

5. Plan for Notified Body Audit: Contact notified bodies from the Notified Bodies List and schedule audits post testing.

6. Submit MD5 Application: Apply through the CDSCO portal and monitor application status closely.

7. Engage with Experienced Consultants: Consider expert regulatory support to navigate complexities and expedite approvals.

By following these practical steps, manufacturers and importers of Nuclear Sealed Calibration Sources can confidently approach the CDSCO licensing process, ensuring compliance and timely market entry.

For personalized assistance, reach out to our expert team who have successfully guided numerous clients through similar regulatory journeys.