CDSCO Registration for Ultrasound Machine: Complete Guide for Importers and Manufacturers 

• Ultrasound machines are regulated as medical devices under MDR 2017 — classified across Class A, B, C, and D based on intended use and patient risk.
• Importers need Form MD-14 application and MD-15 import license from CDSCO before clearing any ultrasound equipment at Indian customs.
• Manufacturers require Form MD-3/MD-5 (Class A/B) or MD-7/MD-9 (Class C/D) — with Class C/D manufacturing licenses approved centrally by CDSCO.
• Wholesale distributors of ultrasound machines must obtain a separate MD-41 wholesale license (Form MD-42 grant) before supplying in the Indian market.

Introduction

CDSCO registration for ultrasound machines is mandatory under the Medical Devices Rules (MDR), 2017. Ultrasound machines fall under Class C or Class D depending on intended use. Importers file Form MD-14 and receive an MD-15 import license. Manufacturers of Class A/B file MD-3 for an MD-5 license; Class C/D manufacturers file MD-7 for an MD-9 license. Wholesale distributors require an MD-41 application and MD-42 license. All licenses are issued through the CDSCO Sugam portal.

What Is CDSCO and Why Does It Regulate Ultrasound Machines?

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for medical devices, operating under the Ministry of Health and Family Welfare. Under the Medical Devices Rules, 2017 (MDR 2017) — notified under the Drugs and Cosmetics Act, 1940 — all medical devices sold or imported in India must be registered and licensed with CDSCO.

Ultrasound machines, also called ultrasonography equipment or sonography machines, use high-frequency sound waves to produce real-time images of internal body structures. They are used across diagnostic radiology, obstetrics, cardiology, emergency medicine, and point-of-care settings. Because they are used directly in clinical decision-making affecting patient outcomes, CDSCO brings them under mandatory regulatory oversight.

CDSCO registration for ultrasound machines ensures that every device entering the Indian market — whether imported or manufactured domestically — meets safety, performance, and quality standards before it is used on patients.

Medical Device Classification: Understanding Class A, B, C, and D

Under MDR 2017, all medical devices are classified into four risk-based classes. The classification determines which regulatory pathway applies — who approves the licence, what documents are needed, and how long the process takes.

Class	Risk Level	Regulatory Authority	Examples (General)
Class A	Low risk	State Licensing Authority (SLA)	Tongue depressors, bandages, basic diagnostic tools
Class B	Low-moderate risk	State Licensing Authority (SLA)	Hypodermic needles, suction equipment, simple diagnostic devices
Class C	Moderate-high risk	CDSCO (Central)	Haemodialysis machines, ventilators, diagnostic imaging devices
Class D	High risk	CDSCO (Central)	Implantable devices, cardiac stents, high-risk life-support equipment

Note: Ultrasound machines are predominantly classified as Class C or Class D under MDR 2017 depending on their intended clinical application. This means their import and manufacturing licenses are approved centrally by CDSCO — not by the State Licensing Authority.

Ultrasound Machine Classification Under CDSCO MDR 2017

CDSCO classifies ultrasound machines under the Medical Devices Rules, 2017, referring to the Third Schedule which lists notified medical devices subject to regulation. The classification of ultrasound equipment is based on intended use, patient contact type, and clinical risk profile.

Class A Ultrasound Devices — Low Risk

Class A devices have the lowest risk profile. Most ultrasound machines used in direct diagnostic or therapeutic applications do not fall in this class. However, some peripheral or ancillary ultrasound-related accessories with no direct patient risk may be categorised here.

CLASS A — Low Risk Ultrasound-Related Devices
Device Type	Typical Use	Patient Contact	Regulatory Body
Ultrasound gel / coupling medium	Coupling agent for probe-skin contact	Indirect / surface	State Licensing Authority
Ultrasound probe covers / sheaths (non-sterile)	Probe hygiene barrier	Indirect	State Licensing Authority
Ultrasound equipment accessories (cables, mounts)	Ancillary support hardware	None	State Licensing Authority

Class B Ultrasound Devices — Low to Moderate Risk

Class B ultrasound-related devices present a slightly elevated risk profile but are still managed at the state level. Standalone diagnostic ultrasound machines that are non-invasive and used for general-purpose imaging may in some configurations fall here, but most imaging systems are Class C.

CLASS B — Low to Moderate Risk Ultrasound Devices
Device Type	Typical Use	Patient Contact	Regulatory Body
Basic handheld ultrasound devices (non-diagnostic output)	Limited-use bedside screening	Non-invasive surface	State Licensing Authority
Ultrasound therapy units (physiotherapy, low-intensity)	Musculoskeletal physiotherapy	External contact	State Licensing Authority
Fetal Doppler (handheld, non-imaging)	Monitoring fetal heartbeat externally	External contact	State Licensing Authority

Class C Ultrasound Devices — Moderate to High Risk

The majority of diagnostic ultrasound machines used in Indian hospitals, clinics, and diagnostic centres fall under Class C. These include general-purpose B-mode scanners, colour Doppler systems, and portable diagnostic ultrasound units. Class C devices require central CDSCO approval for both import and manufacturing licences.

CLASS C — Moderate to High Risk Ultrasound Machines (CDSCO Regulated)
Ultrasound Machine Type	Clinical Application	Key Feature	Regulatory Body
2D B-Mode Ultrasound Scanner	Abdominal, obstetric, pelvic imaging	Real-time 2D grayscale imaging	CDSCO (Central)
Colour Doppler Ultrasound System	Vascular, cardiac, obstetric blood flow	Colour-coded blood flow mapping	CDSCO (Central)
Power Doppler Ultrasound System	Low-velocity vascular flow imaging	Enhanced sensitivity to slow flow	CDSCO (Central)
3D Ultrasound Scanner	Obstetric fetal anatomy, organ volume	Three-dimensional reconstruction	CDSCO (Central)
4D / Real-Time 3D Ultrasound Scanner	Live fetal imaging, cardiology	Real-time volumetric imaging	CDSCO (Central)
Portable / Handheld Diagnostic Ultrasound	Emergency, point-of-care, rural health	Battery-powered mobile unit	CDSCO (Central)
Wireless / Pocket Ultrasound Device	Point-of-care scanning, telemedicine	Smartphone-connected transducer	CDSCO (Central)
Cart-Based Diagnostic Ultrasound Workstation	Radiology departments, OPD imaging	Full-featured trolley-mounted system	CDSCO (Central)
Musculoskeletal (MSK) Ultrasound System	Joint, tendon, nerve imaging	High-frequency linear transducer	CDSCO (Central)
Breast Ultrasound Scanner	Breast lesion characterisation	High-resolution linear imaging	CDSCO (Central)
Thyroid / Superficial Organ Ultrasound System	Thyroid, lymph node, salivary gland	High-frequency probe	CDSCO (Central)
Transcranial Doppler (TCD) System	Cerebrovascular blood flow	Low-frequency pulsed Doppler	CDSCO (Central)
Ophthalmic Ultrasound (A-scan / B-scan)	Ocular biometry, retinal imaging	High-frequency eye probe	CDSCO (Central)
Veterinary Diagnostic Ultrasound	Animal diagnostic imaging	Adapted for animal anatomy	CDSCO (Central)

Class D Ultrasound Devices — High Risk

Class D ultrasound systems are the highest-risk category — typically those used in invasive procedures, cardiac interventions, or where device failure poses direct life-threatening risk. These require the most rigorous CDSCO review and the strictest quality and clinical data standards.

CLASS D — High Risk Ultrasound Machines (CDSCO Regulated)
Ultrasound Machine Type	Clinical Application	Key Feature	Regulatory Body
Echocardiography System (Echo Machine)	Cardiac structure and function assessment	Cardiac-specific probes and protocols	CDSCO (Central)
Transesophageal Echocardiography (TEE) System	Intraoperative and ICU cardiac monitoring	Invasive — probe inserted via oesophagus	CDSCO (Central)
Intravascular Ultrasound (IVUS) System	Coronary artery imaging during catheterisation	Invasive intravascular catheter probe	CDSCO (Central)
High Intensity Focused Ultrasound (HIFU) System	Non-invasive tumour ablation, uterine fibroids	Therapeutic — tissue destruction	CDSCO (Central)
Ultrasound-Guided Biopsy / Intervention System	Image-guided tissue sampling and procedures	Real-time needle guidance	CDSCO (Central)
Intraoperative Ultrasound System	Surgical guidance during open and laparoscopic surgery	Sterile, OR-integrated imaging	CDSCO (Central)
Endoscopic Ultrasound (EUS) System	GI tract and surrounding organ imaging	Invasive endoscope-mounted transducer	CDSCO (Central)
Laparoscopic Ultrasound Probe System	Intra-abdominal imaging during laparoscopy	Laparoscope-compatible probe	CDSCO (Central)

CDSCO License Forms for Ultrasound Machines: Complete Overview

India's MDR 2017 framework uses specific application and licence forms depending on whether you are an importer, manufacturer, or wholesale distributor. Here is how the form structure works for ultrasound machines:

Activity	Application Form	Licence / Grant Form	Issued By	Applicable Class
Import of ultrasound machines	MD-14	MD-15	CDSCO	All classes (A–D)
Wholesale distribution	MD-41	MD-42	State Licensing Authority	All classes (A–D)
Manufacturing (Class A / B)	MD-3	MD-5	State Licensing Authority	Class A & B
Manufacturing (Class C / D)	MD-7	MD-9	CDSCO (Central)	Class C & D

Note: Since most ultrasound machines are Class C or Class D, their manufacturing licenses (MD-7 → MD-9) are approved by CDSCO centrally. Class A/B ultrasound accessories manufactured domestically use the MD-3 → MD-5 pathway through the State Licensing Authority.

MD-14 Application: Import License for Ultrasound Machines

Any company or entity that wants to import ultrasound machines into India for commercial sale, demonstration, or distribution must first obtain a valid import license in Form MD-15 by filing a Form MD-14 application with CDSCO.

Who Must File Form MD-14?

• Foreign ultrasound machine manufacturers exporting to India through an Indian authorised agent
• Indian importers and distributors bringing ultrasound systems from overseas OEMs
• Authorized Indian representatives (AIR) of foreign medical device companies
• Companies importing for re-export, clinical evaluation, or exhibition (separate pathways may apply)

MD-14 Application Process — Step by Step

• Register on the CDSCO Sugam portal (sugam.gov.in) as an importer entity
• Appoint an Authorized Indian Representative (AIR) if the manufacturer is a foreign entity
• Classify the ultrasound machine correctly under MDR 2017 Third Schedule
• Prepare the complete Technical File / Device Master Record (DMR)
• Ensure the device holds a valid CE Mark, US FDA clearance, or approval from a recognized international regulatory authority (MDSAP member country)
• File Form MD-14 online on the Sugam portal with all required documents and fee payment
• CDSCO scrutinizes the application — may raise technical or clinical queries
• Respond to any Additional Information (AI) requests within stipulated timelines
• CDSCO grants the import license in Form MD-15 upon satisfactory review

Documents Required for MD-14 (Import License — Ultrasound Machine)

Document	Details / Requirement
Form MD-14 (duly filled)	Online submission via CDSCO Sugam portal
Certificate of incorporation / business registration	Of the Indian importer entity
Authorisation letter from foreign manufacturer	Appointing the Indian entity as AIR / importer
Foreign regulatory approval (CE / US FDA / TGA etc.)	Valid approval from recognised authority
ISO 13485 certificate of manufacturer	Quality management system certification
Device description and intended use	Clear clinical indication and mode of action
Risk classification justification	Per MDR 2017 classification rules
Essential Principles Checklist (EPC)	Compliance with Schedule III of MDR 2017
Summary Technical Documentation (STED) / Technical File	Performance, safety, biocompatibility data
IEC 60601-1 compliance data	Electrical safety of medical electrical equipment
IEC 60601-2-37 compliance data	Specific to diagnostic ultrasound equipment
Clinical evaluation report / clinical data	Evidence of safety and performance
Labelling (draft) and Instructions for Use (IFU)	In English; Hindi optional but recommended
Post-market surveillance plan	How adverse events will be monitored
Unique Device Identification (UDI) details	As applicable under CDSCO UDI framework
Import Export Code (IEC) of importer	Issued by DGFT, India
Declaration of conformity	By manufacturer

Government Fee for MD-14 (Import License)

Fee Category	Approximate Fee (INR)
Application fee — Class A device	As per MDR 2017 Second Schedule
Application fee — Class B device	As per MDR 2017 Second Schedule
Application fee — Class C device	As per MDR 2017 Second Schedule
Application fee — Class D device	As per MDR 2017 Second Schedule
Import licence renewal fee	Per Second Schedule of MDR 2017

Note: CDSCO revises fee schedules periodically. Always verify the current fee applicable to your device class on the official CDSCO Sugam portal before filing. Fee amounts differ by class and are prescribed under the Second Schedule of MDR 2017.

MD-15: Grant of Import License for Ultrasound Machines

Once CDSCO completes its review of the MD-14 application and is satisfied with all submitted documents and compliance data, it grants the import license in Form MD-15. This is the legal document that authorizes you to import specific ultrasound machine models into India.

Key Features of the MD-15 Import License

• Device-specific — the license specifies the exact model(s) of ultrasound machine covered
• Importer-specific — issued in the name of the Indian entity (importer or AIR)
• Covers the manufacturer's name, manufacturing site, and country of origin
• Validity of 3 years for Class C and D devices; renewable before expiry
• Any model change, manufacturer site change, or labelling update requires license amendment
• A copy of the MD-15 license is required by Indian customs for clearance of each shipment

MD-15 Licence Parameter	Details
Form	MD-15
Issued by	CDSCO (Central)
Covers	Specified ultrasound machine model(s) from a specified manufacturer
Validity	3 years (Class C / D); as notified for Class A / B
Renewal	Apply before expiry via Sugam portal
Amendment	Required for any change in device, site, or labelling

MD-41 Application: Wholesale License for Ultrasound Machines

Any company that supplies, distributes, or sells ultrasound machines to hospitals, clinics, diagnostic centres, or other end-users in India must hold a valid wholesale license. The application for this license is filed in Form MD-41 with the State Licensing Authority of the state where the wholesale business operates.

Who Needs an MD-41 Wholesale License?

• Medical device distributors supplying ultrasound machines to hospitals or diagnostic centres
• Importers who also act as distributors for their own imported portfolio
• Regional wholesalers and stockists of ultrasound equipment
• Branches or depots of national distribution companies operating in specific states

MD-41 Application Process

• Register with the State Licensing Authority (SLA) of the relevant state
• Prepare premises details — dedicated storage area for medical devices is required
• Appoint a technically qualified person (as required by the SLA)
• File Form MD-41 with required documents — online via the state portal or physical submission depending on state
• SLA may conduct a premises inspection
• Pay prescribed state fee
• SLA grants the wholesale license in Form MD-42 upon satisfactory review

Documents Required for MD-41 (Wholesale License)

Document	Details
Form MD-41 (duly filled)	Submitted to State Licensing Authority
Proof of business premises	Ownership or rental agreement
Layout plan of storage / office premises	Storage area must meet SLA standards
Business registration certificate	GST registration, company incorporation etc.
Copy of MD-15 import licence (for importer-distributors)	Showing valid import licence for products being distributed
Details of technically qualified person	As required under MDR 2017 and state notifications
Declaration of compliance	Signed by the applicant / proprietor

MD-42: Grant of Wholesale License for Ultrasound Machines

The State Licensing Authority issues the wholesale license in Form MD-42 after reviewing the MD-41 application and, where applicable, inspecting the premises. This license must be displayed at the place of business and renewed on time.

MD-42 Licence Parameter	Details
Form	MD-42
Issued by	State Licensing Authority (SLA)
Covers	Wholesale distribution of specified medical device categories in the state
Validity	As specified by SLA — typically 5 years
Renewal	Apply before expiry with updated documents
Display requirement	Licence must be displayed at the place of business

MD-3 Application and MD-5 License: Manufacturing License for Class A and B Ultrasound Devices

Domestic manufacturers of Class A or Class B ultrasound-related devices — such as physiotherapy ultrasound units, coupling gels, or basic diagnostic accessories — apply for a manufacturing license through Form MD-3 with the State Licensing Authority.

MD-3 Application Process (Class A / B Manufacturing)

• Identify the correct State Licensing Authority for the manufacturing state
• Ensure manufacturing premises comply with Schedule I of MDR 2017 (GMP requirements)
• Prepare quality management system documentation aligned to ISO 13485
• Appoint qualified technical staff as required under MDR 2017
• File Form MD-3 with the SLA along with all required documents and fee
• SLA conducts a GMP inspection of the manufacturing facility
• Address any inspection observations within specified timelines
• SLA grants the manufacturing license in Form MD-5 upon satisfactory compliance

Documents Required for MD-3 (Class A / B Manufacturing License)

Document	Details
Form MD-3 (duly filled)	Submitted to State Licensing Authority
Proof of manufacturing premises	Ownership / lease agreement
Site master file / plant layout	Manufacturing, QC, storage areas
List of medical devices to be manufactured	With device description and intended use
ISO 13485 quality management system documentation	Or equivalent QMS aligned to MDR 2017 Schedule I
Equipment list and qualification records	All manufacturing and testing equipment
Qualification and experience of technical staff	As per MDR 2017 Schedule II
Process validation and test protocols	For each device class being manufactured
Risk management file (ISO 14971)	Device risk analysis documentation
Draft labels and Instructions for Use (IFU)	For each device intended for manufacture

MD-5: Grant of Manufacturing License (Class A / B)

MD-5 Licence Parameter	Details
Form	MD-5
Issued by	State Licensing Authority (SLA)
Applicable to	Class A and Class B medical device manufacturers
Validity	As specified under MDR 2017 — typically 5 years
Renewal	Before expiry; re-inspection may be required
Scope	Facility and device category specific

MD-7 Application and MD-9 License: Manufacturing License for Class C and D Ultrasound Machines

This is the most critical licensing pathway for domestic manufacturers of diagnostic ultrasound machines in India. Since most ultrasound imaging systems are Class C or Class D, their manufacturing licenses are applied for via Form MD-7 and approved centrally by CDSCO — not the State Licensing Authority.

MD-7 Application Process (Class C / D Manufacturing)

• Register on the CDSCO Sugam portal as a medical device manufacturer
• Ensure manufacturing facility is established and GMP-compliant per Schedule I of MDR 2017
• Obtain ISO 13485 certification from an accredited certification body
• Prepare the complete Technical File / Device Master Record for each ultrasound model
• Generate clinical evaluation / performance data — literature review or clinical trial as applicable
• Prepare Essential Principles Checklist (EPC) per Schedule III of MDR 2017
• File Form MD-7 on the Sugam portal with all required documents and prescribed fee
• CDSCO scrutinizes the application — may raise technical, clinical, or quality queries
• CDSCO conducts or arranges an audit of the manufacturing facility (GMP audit)
• Respond to all CDSCO queries within stipulated timelines
• CDSCO grants the manufacturing license in Form MD-9 upon satisfactory review and inspection

Documents Required for MD-7 (Class C / D Manufacturing License — Ultrasound Machine)

Document	Details / Notes
Form MD-7 (duly filled)	Online submission via CDSCO Sugam portal
Certificate of incorporation	Company registration documents
ISO 13485 certificate	From NABCB-accredited or internationally recognised CB
Manufacturing site details and layout	Full GMP-compliant facility documentation
Device description and intended use statement	For each ultrasound model
Risk classification justification	Per MDR 2017 Third Schedule rules
Essential Principles Checklist (EPC)	Schedule III MDR 2017 compliance mapping
Risk management file (ISO 14971)	Risk analysis, evaluation, and control
Design history file / technical documentation	Engineering drawings, design verification, validation
IEC 60601-1 test report	General electrical safety — accredited lab
IEC 60601-2-37 test report	Safety of diagnostic ultrasound equipment — accredited lab
IEC 62304 software lifecycle documentation	For ultrasound devices with embedded software
IEC 62133 / battery safety (if applicable)	For portable/wireless ultrasound devices
Biocompatibility data (ISO 10993)	For patient-contact components
Clinical evaluation report	Per MEDDEV 2.7/1 or equivalent Indian guidelines
Post-market surveillance plan	Complaint handling, vigilance, PMCF plan
Sterilisation documentation (if applicable)	For sterile accessories
Draft labelling and IFU	In English; as per MDR 2017 labelling requirements
Unique Device Identification (UDI) details	Per CDSCO UDI requirements
Declaration of conformity	Signed by authorised signatory

MD-9: Grant of Manufacturing License (Class C / D)

MD-9 Licence Parameter	Details
Form	MD-9
Issued by	CDSCO (Central Drugs Standard Control Organisation)
Applicable to	Class C and Class D medical device manufacturers
Validity	3 years (as per MDR 2017)
Renewal	Apply before expiry; GMP re-audit may be required
Scope	Facility, device category, and specific model(s)
Post-grant obligation	Mandatory adverse event reporting, PMCF, CDSCO vigilance

MD-14 vs MD-3 vs MD-7: Which License Do You Need?

Criteria	MD-14 / MD-15 (Import)	MD-3 / MD-5 (Mfg A/B)	MD-7 / MD-9 (Mfg C/D)	MD-41 / MD-42 (Wholesale)
Who it is for	Importers of ultrasound machines	Manufacturers — Class A/B devices	Manufacturers — Class C/D devices	Wholesale distributors
Filed with	CDSCO (Central)	State Licensing Authority	CDSCO (Central)	State Licensing Authority
Ultrasound class relevance	All classes (A–D)	Class A/B accessories only	Class C/D ultrasound machines	All classes (A–D)
GMP inspection	Document review only	SLA site inspection	CDSCO GMP audit	Premises inspection
ISO 13485 required	Overseas manufacturer's	Yes (or equivalent)	Yes (mandatory)	Not typically
Clinical data required	Yes (for Class C/D)	Limited (Class A/B)	Yes (mandatory for C/D)	No
Typical timeline	6–18 months (Class C/D)	3–9 months	9–24 months	4–12 weeks

Key Standards and Compliance Requirements for Ultrasound Machines in India

CDSCO expects ultrasound machine manufacturers and importers to demonstrate compliance with internationally recognized technical standards. Here are the primary standards applicable to ultrasound equipment:

Standard	Scope	Applicable To
IEC 60601-1:2005+A1:2012	General electrical safety for medical electrical equipment	All powered ultrasound machines
IEC 60601-2-37:2007+A1:2015	Safety of diagnostic ultrasound equipment	All diagnostic ultrasound systems
IEC 62304:2006+A1:2015	Software lifecycle processes for medical device software	Ultrasound systems with embedded software / AI
ISO 10993 (series)	Biocompatibility of medical devices	Patient-contact probes and accessories
ISO 14971:2019	Risk management for medical devices	All ultrasound devices
ISO 13485:2016	Quality management system for medical devices	All manufacturers
IEC 62133 / IEC 62368-1	Battery / audio-video safety standards	Portable / wireless ultrasound devices
AIUM / IEC 61157	Acoustic output measurement	Diagnostic ultrasound output labelling

CDSCO Ultrasound Machine Registration: Timeline Overview

Licence Type	Typical Processing Time	Main Factors Affecting Timeline
MD-15 Import Licence (Class C/D ultrasound)	6 to 18 months	Document completeness, CDSCO query rounds, clinical data quality
MD-15 Import Licence (Class A/B accessories)	2 to 6 months	Simpler documents, SLA processing
MD-9 Manufacturing Licence (Class C/D)	9 to 24 months	GMP audit scheduling, technical file review, query responses
MD-5 Manufacturing Licence (Class A/B)	3 to 9 months	SLA workload, GMP inspection scheduling
MD-42 Wholesale Licence	4 to 12 weeks	State SLA workload, premises inspection

Note: These timelines are indicative. A complete and well-prepared application with all documents correct from the first submission significantly reduces the total processing time.

Post-Market Obligations After Getting CDSCO License for Ultrasound Machine

Obtaining the licence is only the beginning. Once your ultrasound machine is on the Indian market, both importers and manufacturers have ongoing regulatory obligations under MDR 2017.

• Adverse Event Reporting: Any serious incident or malfunction must be reported to CDSCO within specified timelines
• Field Safety Corrective Actions (FSCA): Initiate and report any product recalls or safety corrections
• Post-Market Clinical Follow-Up (PMCF): Ongoing clinical data collection to support continued safety evidence
• Periodic Safety Update Reports (PSUR): Submit as required by CDSCO
• Vigilance reporting: Annual summary reporting of complaints and adverse events
• Labelling updates: Any change requires CDSCO approval before implementation
• License renewal: File before expiry — operating with an expired license is a violation

CDSCO 2026 Regulatory Updates for Medical Devices Including Ultrasound Machines

India's medical device regulatory framework is evolving rapidly. Here is what importers and manufacturers need to be aware of in 2026:

Mandatory CDSCO Registration Now Covers More Device Categories

CDSCO has progressively brought more medical device categories under mandatory MDR 2017 registration through notification waves. Ultrasound machines were among the earlier categories notified, and enforcement has strengthened significantly since 2022. As of 2026, CDSCO actively scrutinises import shipments at ports and seizes non-licensed ultrasound devices.

Digital Submission via Sugam Portal

The CDSCO Sugam portal has become the primary gateway for all MD-14 and MD-7 applications. Paper-based submissions are no longer accepted for import and Class C/D manufacturing licences. Applicants must ensure their digital certificates, signatures, and uploaded documents meet portal requirements.

UDI (Unique Device Identification) Framework

CDSCO is implementing a UDI system for medical devices in India, aligned with global frameworks like FDA UDI and EU MDR UDI. Ultrasound machine importers and manufacturers should begin UDI implementation planning as mandatory compliance timelines approach.

AI-Enabled and Software-Driven Ultrasound Systems

Ultrasound machines with integrated AI diagnostic algorithms, deep-learning analysis, or cloud-connected features are subject to additional regulatory scrutiny. CDSCO is developing specific guidance on AI/ML-based medical devices. If your ultrasound machine has AI-assisted diagnosis features, factor in additional documentation requirements for your IEC 62304 software lifecycle and clinical evaluation.

Why Work with a CDSCO Medical Device Consultant for Ultrasound Machine Registration?

CDSCO registration for ultrasound machines — particularly Class C and D systems — is technically complex. The documentation requirements, standard compliance expectations, and regulatory timelines make it one of the more demanding registration exercises under MDR 2017. Here is where expert support makes a tangible difference:

Challenge	How a Consultant Helps
Correct device classification	Ensures the right class is assigned, avoiding misclassification rejections
Technical file preparation	Builds a complete, CDSCO-compliant STED / DMR from existing OEM documents
Standard compliance mapping	Maps IEC 60601-1, IEC 60601-2-37, ISO 14971, etc. to CDSCO EPC
Application filing on Sugam	Handles all portal submissions, fee payments, and documentation uploads
Query response management	Drafts precise, technically sound responses to CDSCO queries
GMP audit preparation	For manufacturers: prepares facility for CDSCO GMP inspection
Wholesale licence coordination	Manages MD-41 filings across multiple states for distribution networks
Post-market compliance	Sets up adverse event reporting, PMCF, and vigilance processes
Renewal tracking	Proactively tracks MD-15 and MD-9 expiry to prevent licence lapse

Silvereye Certifications works with ultrasound machine importers and manufacturers on end-to-end CDSCO registration — from initial device classification and technical file preparation through to MD-15 or MD-9 license grant and ongoing post-market compliance support. Their team is familiar with both the Sugam portal workflows and the technical documentation standards CDSCO expects for Class C and D diagnostic imaging devices.

Conclusion

CDSCO registration for ultrasound machines in India is a structured, multi-step process governed by the Medical Devices Rules, 2017. The pathway you follow depends entirely on whether you are importing or manufacturing, and which device class your ultrasound machine falls under.

For most importers of diagnostic ultrasound systems, the journey is Form MD-14 to Form MD-15, with CDSCO reviewing a comprehensive technical file that includes CE/FDA approval, ISO 13485, IEC 60601-2-37 test data, and clinical evaluation evidence. For domestic manufacturers of Class C or D ultrasound machines, the route is Form MD-7 to Form MD-9 — including a GMP audit of the manufacturing facility.

Wholesale distributors must separately hold an MD-42 license from the State Licensing Authority before distributing in the Indian market. And Class A/B device manufacturers use the simpler MD-3/MD-5 state-level pathway.

The regulatory investment is significant — but so is the Indian medical imaging market. Getting the registration right the first time, with complete documentation and a clear compliance strategy, is the fastest path to market entry. Silvereye Certifications supports both importers and manufacturers through the complete CDSCO ultrasound machine registration process, from classification to license grant.

Frequently Asked Questions