CDSCO License for Radionuclide dynamic function testing equipment
Medical Device Information
Intended Use
A device used to measure and record temporal variations of radioisotope concentrations in the body. Specialized devices, such as devices for thyroid uptake measurement, renograms, and radioisotope blood volume measurement, are included.
Comprehensive Guide to CDSCO Licensing for Radionuclide Dynamic Function Testing Equipment
Radionuclide dynamic function testing equipment plays a crucial role in radiotherapy by measuring temporal variations of radioisotope concentrations within the body. This includes specialized diagnostic devices such as thyroid uptake measurement tools, renograms, and radioisotope blood volume measurement devices. Given the device's complexity and patient safety implications, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to enter the Indian market.
With over 25 years of experience assisting more than 500 companies in navigating CDSCO licensing, we provide in-depth, actionable insights tailored to this device’s regulatory pathway.
CDSCO Regulatory Framework for Radionuclide Dynamic Function Testing Equipment
Under the Medical Device Rules (MDR) 2017, Radionuclide dynamic function testing equipment is classified as a Class B medical device due to its moderate risk profile. The CDSCO oversees regulatory approvals for such devices, ensuring compliance with safety, efficacy, and quality requirements. Licensing involves a detailed process including test license acquisition, product testing by notified laboratories, technical dossier submission, and facility audits.
These steps align with the notification File No. 29/Misc./03/2020-DC (180) dated 6.8.2021, which officially recognizes this device under the radiotherapy category.
For further clarity on classification, consult the Medical Device Classification guide.
Risk Classification and License Requirements
Being a Class B device, Radionuclide dynamic function testing equipment requires an MD5 manufacturing license. This license is granted by the State Licensing Authority and involves the following key phases:
- Obtaining a Test License (Form MD13) to facilitate product testing
- Conducting product testing at government-approved laboratories
- Preparing comprehensive technical documentation
- Undergoing an audit by a notified body
- Resolving queries raised by the CDSCO or notified bodies
- Final grant of the MD5 manufacturing license (Form MD5)
Manufacturing License Process (MD5)
The MD5 licensing process typically spans 3-4 months, broken down as follows:
Test License Application (Form MD13): Submit via the CDSCO MD Online Portal. Approval takes approximately 1.5-2 months.
Product Testing: Conducted at CDSCO-approved laboratories. Refer to the Testing Laboratories list for authorized facilities.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, and Risk Management documentation.
Application Submission (Form MD3 for MD5): Apply for the manufacturing license through the CDSCO portal.
Audit: A notified body from the Notified Bodies list performs the facility audit.
Query Resolution: Address any observations or queries raised.
License Grant: Upon satisfactory compliance, the MD5 license is issued.
Our detailed MD5 License Guide offers step-by-step assistance.
Manufacturing License Documents Required
For Radionuclide dynamic function testing equipment, the following documents are essential:
- Company Constitution and incorporation certificates
- Proof of ownership or lease agreement of manufacturing premises
- Technical staff qualifications and experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing, and validation processes (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing infrastructure (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File outlining hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Ensuring completeness and accuracy of these documents significantly reduces processing delays.
Import License Process (MD15)
While this guide primarily focuses on manufacturing licenses, importers of Radionuclide dynamic function testing equipment must apply for an MD15 import license granted by the Central Licensing Authority. The process includes:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, and other technical documentation
- Application submission on the CDSCO MD Online Portal using Form MD14
- Resolution of departmental queries
- License issuance (Form MD15)
The import license process typically takes 5-6 months. For detailed steps, refer to our Import License Guide.
Import License Documents Required
Importers must submit:
- Valid manufacturing license from the exporting country
- Free Sale Certificate or equivalent
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution and related corporate documents
Timeline and Processing Duration
| License Type | Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Application submission, approval |
| Product Testing | 2 – 4 weeks | Laboratory testing and report generation |
| MD5 License (Form MD3) | 1.5 – 2 months | Documentation review, audit, query resolution |
| Total Time | 3 – 4 months | From test license to final MD5 license grant |
Planning your application timeline accordingly is crucial to avoid market entry delays.
Government Fees and Costs
For Class B devices like Radionuclide dynamic function testing equipment, fees are as follows:
- Test License (MD13): Approximately Rs 5,000
- MD5 Manufacturing License Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs include laboratory testing fees and notified body audit charges, which vary depending on the scope.
Common Challenges and Solutions
Challenge 1: Delays in Test License Approval
- Solution: Submit a complete application with all required documents and follow up proactively via the CDSCO MD Online Portal.
Challenge 2: Incomplete or Inadequate Documentation
- Solution: Utilize checklists and expert consultation to prepare robust Device and Plant Master Files, and ensure Risk Management files are up to date.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal mock audits before the notified body visit and address any gaps promptly.
Challenge 4: Query Resolution Delays
- Solution: Respond to queries comprehensively and within stipulated timelines to avoid suspension of application processing.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape can be challenging. Our team, with over two decades of experience and a proven track record supporting 500+ companies, offers:
- End-to-end license application management
- Customized document preparation including DMF and PMF
- Pre-audit support and gap analysis
- Liaison with CDSCO officials and notified bodies
Partnering with experts reduces risks, accelerates approvals, and ensures regulatory compliance.
Getting Started with Your CDSCO License Application
To initiate your licensing process for Radionuclide dynamic function testing equipment:
- Assess Device Classification: Confirm the Class B risk category and understand applicable rules.
- Prepare Documentation: Begin compiling the Device Master File and Plant Master File per CDSCO guidelines.
- Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
- Coordinate Product Testing: Engage with notified testing laboratories early to schedule tests.
- Plan for Audit: Select a notified body from the official Notified Bodies list and prepare your manufacturing site.
- Submit Manufacturing License Application: Once testing and documentation are complete, file Form MD3 on the CDSCO portal.
Timely initiation and meticulous preparation streamline the licensing journey and facilitate a successful market entry.
For further personalized assistance, reach out to our regulatory experts who can tailor solutions specifically for your Radionuclide dynamic function testing equipment license application.
By understanding the detailed regulatory requirements and leveraging expert support, manufacturers and importers can confidently bring their Radionuclide dynamic function testing equipment to the Indian healthcare market with full CDSCO compliance.
