Posted by The manufacture and import of interventional radiology medical devices are subject to strict scrutiny and compliance with the Indian medical device rules 2017. These regulations, under the Central Drugs Standard Control Organization (CDSCO), are important to get the medical devices license.
The process involves finding the risk class of your device and filing the application form to obtain the respective license. This post explains the entire multi-step procedure pertaining to the CDSCO radiology medical devices licence and how, with the help of Dueran Consultants, you can make it easier.
What are Interventional Radiology Medical Devices?
Interventional radiology (IR) medical devices are essential for visualize internal body structures to diagnose and treat various conditions without needing the doctor to do open surgery. They combine advanced imaging systems that guide the procedures with precision tools that are used to do actual interventions.
IR devices are widely used in modern healthcare and must meet stringent & most recent CDSCO regulatory requirements to ensure the safety and performance of devices. Here’s a look at major IR medical devices:
- Imaging systems: MRI machines, X-ray units, and Doppler ultrasound systems that provide real-time visuals to guide procedures.
Radiology Device Regulatory Requirements by CDSCO
To register and get the license for your interventional radiology devices, you must first understand its risk class.
- Form MD 5 license is needed to manufacture Class A & B radiology medical devices
- Form MD 9 license is required for class C and D devices.
- Manufacturers without a medical device manufacturing facility should apply for a CDSCO loan license. They will have to manufacture their devices in the facility of a different medical device manufacturer holding a valid license under the rules.
All manufacturers, importers/ authorized agents of radiology medical devices need to comply with the CDSCO guidelines to get the approval. The regulatory process followed by CDSCO are as below:
- Risk-based classification of devices
- Filling for respective license
- Quality management systems compliance
- Labelling requirements as per MDR 2017
- Post-market Surveillance of Devices
CDSCO Classification of Interventional Radiology Medical Devices
| S No. | Medical Device Name | Risk Class |
| 1 | Scintillation (gamma) camera | A |
| 2 | Positron camera | A |
| 3 | Nuclear whole body counter | A |
| 4 | Bone densitometer | C |
| 5 | Bone sonometer | B |
| 6 | Emission computed tomography system. | C |
| 7 | Fluorescent scanner | C |
| 8 | Nuclear rectilinear scanner | A |
| 9 | Nuclear tomography system | C |
| 10 | Nuclear uptake probe | A |
| 11 | Nuclear whole body scanner | A |
| 12 | Nuclear scanning bed | A |
| 13 | Radionuclide dose calibrator | B |
| 14 | Radionuclide rebreathing system | C |
| 15 | Nuclear sealed calibration source | A |
| 16 | Nuclear electrocardiogra ph synchronizer | A |
| 17 | Nonfetal ultrasonic monitor | B |
| 18 | Ultrasonic pulsed doppler imaging system | B |
| 19 | Ultrasonic pulsed echo imaging system | B |
| 20 | Diagnostic ultrasonic transducer | B |
| 21 | Angiographic x- ray system | C |
| 22 | Diagnostic x-ray beam-limiting device | C |
| 23 | Cine or spot fluorographic x- ray camera | C |
| 24 | Electrostatic x- ray imaging system | C |
| 25 | Radiographic film marking system | A |
| 26 | Image- intensified fluoroscopic x-ray system | C |
| 27 | Non-image- intensified fluoroscopic x-ray system | C |
| 28 | Spot-film device | B |
| 29 | Diagnostic x-ray high voltage generator | A |
| 30 | Mammographic x-ray system | C |
| 31 | Photofluorograp hic x-ray system | C |
| 32 | Diagnostic x-ray tube housing assembly. | A |
| 33 | Diagnostic x-ray tube mount | A |
| 34 | Pneumoenceph alographic chair | B |
| 35 | Radiologic patient cradle | A |
| 36 | Radiographic film | A |
| 37 | Radiographic film cassette | B |
| 38 | Radiographic film/cassette changer | B |
| 39 | Programmer Wall-mounted | B |
| 40 | radiographic cassette holder | A |
| 41 | Radiographic film illuminator | A |
| 42 | Automatic radiographic film processor | C |
| 43 | Radiographic grid | A |
| 44 | Radiographic head holder | A |
| 45 | Radiologic quality assurance instrument | A |
| 46 | Radiographic intensifying screen | A |
| 47 | Radiographic ECG/respirator synchronizer | A |
| 48 | Radiologic table | A |
| 49 | Transilluminator for breast evaluation | D |
| 50 | Medical image storage device | A |
| 51 | Radiological computer- assisted diagnostic software for lesions suspicious of cancer | C |
| 52 | Medical image analyzer | B |
| 53 | Radiological computer aided triage and notification software | C |
| 54 | Full-body MRI system, permanent magnet | C |
| 55 | Full-body MRI system, resistive magnet | C |
| 56 | Full-body MRI system, superconducting magnet | C |
| 57 | Foetal cardiac monitor | C |
| 58 | Foetal Doppler system | C |
| 59 | Flexible ultrasound colonoscope | B |
| 60 | Flexible ultrasound duodenoscope | B |
| 61 | Flexible ultrasound gastroduodenos cope | B |
| 62 | Flexible ultrasound laparoscope | B |
| 63 | Flexible ultrasound bronchoscope | B |
| 64 | Bladder ultrasound imaging transducer | B |
| 65 | Blood flowmeter catheter, Doppler | C |
| 66 | General- purpose ultrasound imaging system | B |
CDSCO Approval Process for Interventional Radiology Medical Devices
The CDSCO registration process to get a radiology medical devices license consists of several steps. Here’s an overview of the major steps:
- Determine regulatory status – Check if the device comes under the CDSCO’s notified list. If it does not, file an application for the No Objection Certificate (NOC) at CDSCO.
- Appoint an Indian representative – Foreign manufacturers need to appoint Authorized Indian Agent (IAA) through whom compliance and communication for the import and market of radiology medical devices in India will be done.
- File your license application – Submit the application for your medical devices license at CDSCO’s MD Sugam portal.
- Regulatory review and queries – CDSCO will review it, and if something is needed, you will be notified about it on Medical Device Sugam Portal.
- Issuance of license – After Scrutiny of submitted documents and compliance of requirements under Medical Devices Rules 2017, CDSCO will issue the Medical device license.
- Validity of approvals – The validity of the import and manufacturing license issued under Medical Device Rules 2017 for your devices shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the licence holder deposits the licence retention fee every five years with the Licensing Authority.
Required Documentation for CDSCO Interventional Radiology Medical Devices Registration
The documents for IR medical device registration demonstrate your commitment to regulatory compliance and the Safety, Performance and quality of your devices. This include the following:
1. Formal letters & authorizations
- A detailed covering letter outlining the application purpose
- Authorization letter appointing the Indian Agent or local representative under Power of Attorney.
2. Regulatory forms & receipts
- Complete application form for device registration
- Government Challan as proof of fee payment
3. Licenses & certificates
- Copy of the valid wholesale license of the Indian Agent/Importer
- Free Sale Certificates
- ISO 13485 certification verifying quality management systems
- CE Full Quality Assurance (QA) certificate
- CE Design Examination Certificate or equivalent regulatory approval
- Declaration of Conformity confirming adherence to relevant standards
4. Supporting compliance records
- Recent audit report of the manufacturing facility
- Complete Plant Master File and Device Master File as per rules.
Challenges in CDSCO Interventional Radiology Medical Devices Registration
Getting a license to manufacture or import radiology medical devices is challenging because of the long-drawn processes involving extensive documentation and site audit. Here are the common areas that feel like hurdles to those trying to get a license.
1. Misclassifying devices
Companies often wrongly classify their devices, leading to application rejection. New manufacturers often struggle to find the right risk class for their radiology device. This happens because CDSCO keeps updating it periodically.
2. Documentation Pitfall
Another major and often irritating challenge is correct documentation. Those like Device Master File, Plant Master File, ISO certificates, Free Sale Certificate, and more need to be in the right format for review by the authorities. Even minor errors and missed details delays the approval process.
3. Finding the SUGAM portal complex
The SUGAM portal has been made keeping in minds the needs and background of the target users. Still, creating an account on the Medical Device Sugam portal, uploading documents, and submitting fees are confusing for many companies. The process becomes more complex, technical, and lengthy if the portal itself turns glitchy.
4. Finding a qualified Indian agent
Finding an Indian Authorized Agent is difficult for foreign manufacturers. If the agent does not have require license or experience, it leads to non-compliance.
5. Keeping pace with regulatory changes
Being aware of the most recent announcements and updates by CDSCO is another hurdle. If you miss any important update, it will reflect in your application process and, most often, cause a delay in approval.
How Dueran Consultant Helps You
Dueran Consultant helps you get past all the above challenges with end-to-end regulatory support. Our experienced professionals ensure that your application is accurate and as per the latest guidelines. If you are a manufacturer or an Indian agent, we assist you by managing regulatory compliance requirements on your behalf.
Concluding Words
A successful CDSCO approval for interventional radiology devices is a sign of the safety, performance and quality of your devices. However, following the exact process can be challenging due to the endless rules and regulations.
Our expertise enables your radiology devices to get quick approval. We offer our support in handling all compliance activities and keep you up-to-date from start to finish. Our professionals also communicate with regulatory agencies on your behalf so you don’t face any technical complexity.
Get in touch with us for affordable and hassle-free authorization of your radiology medical devices.
Frequently Asked Questions (FAQ’s)
1. Where can I find a classification list of medical devices?
You can find the list of medical devices on the official CDSCO website. Keep checking it to find out the risk class your device belongs to.
2. What are Classes of medical devices?
- Class A includes low-risk devices, like Nuclear whole-body Scanner.
- Class B includes low-to-moderate-risk devices, like Ultrasonic pulsed Doppler imaging system
- Class C has moderate-to-high-risk devices, like Electrostatic X- ray imaging system
- Class D has high-risk devices, like Transilluminator for breast evaluation
