Imaging medical devices have revolutionized the way healthcare professionals diagnose and treat various conditions. They offer non-invasive insights into the human body. Hence, it is vital they perform as intended. Given that diagnosis depends on imaging findings, effective imaging devices are required for improved patient care. Central Drugs Standard Control Organization (CDSCO) sets regulatory standards for medical devices in India. Imaging medical devices manufacturers and importers are required to comply with the set regulatory guidelines. Also, they must be familiar with the evolving registration landscape. Moreover, it is mandatory to secure the CDSCO license for imaging medical devices. In this guide, we provide a detailed look into CDSCO registration for imaging medical devices. Additionally, we have provided an overview of the CDSCO imaging medical devices classification system. Furthermore, we have provided some tips on how to overcome the common CDSCO medical device license application hurdles.

Understanding CDSCO Classification for Imaging Medical Devices

Medical devices are classified based on the potential risks associated with their use. The CDSCO medical device classification system has been developed to simplify the CDSCO medical device license application process. Different forms and application processes are applicable for the different CDSCO classes, A, B, C, and D.

Imaging medical devices are crucial for accurate diagnosis and treatment planning. Their findings will impact patient prognosis and outcome. Hence, stringent guidelines have been formulated for CDSCO registration for imaging medical devices. The CDSCO classification system helps streamline the CDSCO registration process. To check which class your medical device belongs to, you can use our free tool.

CDSCO imaging medical devices classes

We have listed few examples of medical devices belonging to each CDSCO class.

CDSCO class A

• Nuclear sealed calibration source
• Nuclear electrocardiograph synchronizer
• Radionuclide test pattern phantom
• Diagnostic x-ray tube housing assembly
• Medical image storage device

CDSCO class B

• Non-foetal ultrasonic monito
• Ultrasonic pulsed doppler imaging system
• Ultrasonic pulsed echo imaging system
• Diagnostic x-ray high voltage generator
• Diagnostic ultrasonictransducer
• Flexible ultrasound colonoscope
• Flexible ultrasound duodenoscope
• Flexible ultrasound duodenoscope
• General-purpose ultrasound imaging system

Class C

• Angiographic x-ray
• Full-body MRI system, permanent magnet
• Full-body MRI system, resistive magnet
• Full-body MRI system, superconducting magnet
• Emission computed tomography system
• Fluorescent scanner
• Diagnostic x-ray beam-limiting device
• Cine or spot fluorographic x-ray camera
• Non-image-intensified fluoroscopic x-ray system
• Spot-film device
• Mammographic x-ray system
• Full-field digital mammography System
• Electrostatic x-ray imaging system

CDSCO class D

• Foetal cardiac monitor
• Transilluminator for breast evaluation

The New CDSCO Guidelines: What’s Changed?

CDSCO is committed to ensure patient safety and product efficacy. It has refined the guidelines for CDSCO registration for imaging medical devices. For Class C and Class D imaging medical devices, the focus is on rigorous testing and quality assurance. Additionally, it requires the imaging medical device manufacturing process to align with international manufacturing standards. Thus, these steps will help CDSCO achieve its aim of making India a global medical device hub.

The Deadline: Key Dates to Remember

CDSCO has transitioned Class C and Class D imaging medical devices from the mandatory registration system to a licensing structure. This has been detailed in GSR 102(E) dated 11.02.2020. Notably, this significant shift will be in effect from October 1, 2023.

Manufacturers and importers are advised to follow the Medical Devices Rules (MDR) 2017. They are required to submit their applications through CDSCO’s online portal, complete with the required documents and fees. For a more in-depth understanding, the official CDSCO circular is an invaluable reference.

CDSCO Registration for Imaging Medical Devices in India

CDSCO Registration for Imaging Medical Devices: Licensing, Requirements, and Forms

• Manufacturing class A and B imaging medical devices: MD 5 License is required to manufacture class A and B imaging medical devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Additionally, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D imaging medical devices: MD 9 License is required to manufacture class C and D imaging medical devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing imaging medical devices into India: MD 15 Import License has to be secured from the CDSCO to import imaging medical devices into India.

Documents Required for CDSCO Registration for Imaging Medical Devices

We have provided an overview of the documents required for securing the CDSCO imaging medical device license.

1. Sale Deed/Rent Deed of the Premises
2. Plant Master File
3. Building Layout with Dimension
4. Device Master File
5. Test License, if required for testing the imaging medical device
6. ISO 13485 Certificate
7. Organization identity proof
8. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
9. Environmental regulation compliance documents
10. Certificate of analysis of 3 consecutive batches

A Step-by-step Guide for the CDSCO Registration for Imaging Medical Devices

We have provided a step-by-step guide of the CDSCO imaging medical device license application journey.  

• Document preparation: Collate all necessary supporting documents, including clinical trial data and product specifications. Additionally, the documents have to be arranged per CDSCO requirements.

• Application Submission: File the application online on the official CDSCO online portal, SUGAM.
• Query Resolution: Promptly address any queries raised by CDSCO regarding the application.
• Inspection: Prepare for the CDSCO medical device facility inspection and audit phase.
• License Approval: CDSCO will review the application and verify the documents. Once all criteria are met, CDSCO will grant the license.

Validity of the CDSCO Imaging Medical Device License

CDSCO imaging medical device license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

Common CDSCO License Application Challenges and How to Overcome Them

Manufacturers and importers applying for the CDSCO imaging medical device license might encounter the following challenges. Hence, we have provided some tips on how to overcome them.

• Documentation Gaps: Ensuring all documents are current and meet CDSCO’s standards. Additionally, they should be arranged per CDSCO’s requirement.
• Delays in Query Resolution: Establishing a dedicated team to address CDSCO queries swiftly.
• Inspection Hurdles: Conducting regular internal audits of facilities to ensure they align with CDSCO guidelines.

How Can Pharmadocx Consultants Assist with CDSCO Registration for Imaging Medical Devices?

Pharmadocx Consultants offers a suite of services tailored for imaging medical device manufacturers:

• Expert Guidance: Assistance throughout the registration journey.
• Mock Audits: Conducting pre-inspection audits to ensure readiness.
• Query Resolution: Swiftly addressing CDSCO queries.
• End-to-End Support: Comprehensive backing from the initial application to license approval.
• Learn More

Compliance with CDSCO regulatory guidelines is mandatory for marketing medical devices in India. Regulatory compliance is a testament of the manufacturer’s dedication to patient safety and product quality. Moreover, ensuring regulatory adherence not only fosters trust but also solidifies the brand’s reputation in the market. Furthermore, the mandatory CDSCO registration for imaging medical devices ensures healthcare professionals are equipped with the most advanced diagnostic tools. However, the CDSCO guidelines can be difficult to comprehend. Furthermore, the CDSCO imaging medical device license application process can be tricky and arduous. With the support of our team of experts, you can have a smooth CDSCO regulatory journey. Are you planning to secure CDSCO license for imaging medical devices? Well, look no beyond. Simply drop an email at [email protected] or call/Whatsapp on 9996859227 to get started.