CDSCO Registration for X-Ray Equipment: Complete Guide For Manufacturer, Importer & Wholesaler

• Most complete X-ray systems are Class C: CDSCO's official radiology classification list places general-purpose, mammographic, fluoroscopic, and dental X-ray systems in Class C, requiring the Central Licensing Authority route.
• Components and accessories are often Class A/B: Film cassettes, high-voltage generators, tube housings, and beam-limiting devices are typically Class B, while basic measurement accessories are Class A.
• Importers always use MD-14/MD-15: Regardless of class, an authorized Indian agent files Form MD-14 and receives the import license on Form MD-15 from CDSCO.
• Wholesalers always use MD-41/MD-42: Any business stocking, supplying, or distributing X-ray equipment needs the registration certificate granted on Form MD-42, applied for via Form MD-41.

Introduction

CDSCO registration for X-ray equipment is mandatory under the Medical Devices Rules, 2017, and the process depends on the specific device's risk class. According to CDSCO's official radiology classification notice, basic accessories like an X-ray film ruler are Class A, imaging components like film cassettes and high-voltage generators are Class B, and most complete X-ray imaging systems — general-purpose, mammographic, fluoroscopic, dental, and mobile/portable units — are Class C.

Class A/B manufacturers apply on Form MD-3 and receive the license on Form MD-5 from the State Licensing Authority. Class C manufacturers apply on Form MD-7 and receive the license on Form MD-9 directly from CDSCO's Central Licensing Authority. Importers use Form MD-14 (granted as MD-15), and wholesalers/distributors use Form MD-41 (granted as MD-42), regardless of class.

What Is CDSCO Registration for X-Ray Equipment?

CDSCO registration for X-ray equipment is the regulatory approval issued by the Central Drugs Standard Control Organization (CDSCO), under India's Ministry of Health and Family Welfare, that authorizes a business to manufacture, import, or distribute X-ray imaging systems and their components in India. This covers complete diagnostic X-ray systems (general-purpose, mobile, portable, dental, mammographic, fluoroscopic) as well as individual components like high-voltage generators, tube housings, detectors, and film cassettes. These devices are regulated under the Medical Devices Rules, 2017 (MDR 2017), notified under the Drugs and Cosmetics Act, 1940.

CDSCO originally notified 66 radiology medical devices on 13 September 2021, and has since issued more detailed, updated classification notices — including a comprehensive Interventional Radiology risk classification list dated 27 November 2025 that names specific X-ray system types and components individually. Because a complete X-ray machine and a simple accessory like a film ruler carry very different risk profiles, CDSCO applies different licensing routes depending on the exact product, rather than treating all X-ray equipment as a single category.

How CDSCO Classifies X-Ray Equipment: Class A, B & C

Based on CDSCO's most recent official radiology classification notice, X-ray equipment is distributed primarily across Class A, B, and C. Notably, this update does not place any complete X-ray imaging system in Class D — the highest-risk classification in radiology is reserved for select invasive, catheter-based imaging-adjunct devices (such as certain intravascular ultrasound catheters) rather than X-ray machines themselves.

Class A X-Ray Equipment

Class A X-ray-related devices are low-risk accessories that support imaging without generating or directly controlling X-ray beams themselves:

Class B X-Ray Equipment

Class B covers the individual components and accessories that make up an X-ray system — generators, detectors, cassettes, and imaging support hardware:

Class C X-Ray Equipment

Class C is where most complete, patient-facing X-ray imaging systems sit — general-purpose diagnostic units, fluoroscopy systems, mammography systems, and dental imaging systems:

If your product is a complete X-ray imaging system rather than a standalone component, it is very likely to fall in Class C and require the MD-7/MD-9 manufacturing route through CDSCO's Central Licensing Authority.

Who Needs CDSCO Registration for X-Ray Equipment?

CDSCO registration applies separately to each role in the X-ray equipment supply chain, and the manufacturing form depends on class:

CDSCO Manufacturing License: MD-3/MD-5 (Class A/B) vs. MD-7/MD-9 (Class C)

Class A/B X-Ray Components — Form MD-3 & MD-5

• Applicant must be a registered business entity with a defined manufacturing premise in India.
• Quality Management System aligned with ISO 13485:2016, proportionate to the specific component.
• Application filed on Form MD-3 via the CDSCO SUGAM portal, with a Site Master File and Device Master File.
• Reviewed and granted by the State Licensing Authority (SLA) on Form MD-5.
• Typical processing time: approximately 3–6 months.

Class C X-Ray Systems — Form MD-7 & MD-9

• Applicant must meet the same business-entity and premise requirements, with a substantially more rigorous Quality Management System given the ionizing-radiation function of the equipment.
• Application filed on Form MD-7 via the SUGAM portal, with a comprehensive Device Master File, electrical safety and radiation-safety compliance data, and performance testing data.
• Reviewed and granted directly by CDSCO's Central Licensing Authority on Form MD-9.
• A facility inspection by CDSCO's Medical Device Officers is typically scheduled within 60 days of a complete application.
• Typical processing time: approximately 6–9 months, reflecting the deeper technical review required for Class C imaging systems.

Documents Required for X-Ray Equipment Registration

Common Documents (All Classes)

• Covering letter and duly filled application form (MD-3 for Class A/B, MD-7 for Class C).
• Proof of constitution of the firm (incorporation certificate, partnership deed, GST registration).
• Site Master File describing the manufacturing premises and layout.
• Device Master File covering technical specifications, intended use, and labelling.
• Details of manufacturing plant, machinery, and quality-control equipment.
• Undertaking of compliance with Essential Principles of safety and performance under MDR 2017.

Additional Documents for Class C X-Ray Systems

• Electrical safety testing data (per IEC 60601 series) appropriate to a powered radiological device.
• Radiation-safety and dose-output performance data demonstrating compliance with applicable radiological safety standards.
• Image quality/performance testing data appropriate to the system's imaging modality (general radiography, fluoroscopy, mammography, or dental).
• Risk management documentation aligned with ISO 14971 principles.

CDSCO Import License for X-Ray Equipment (MD-14 & MD-15)

Foreign manufacturers cannot sell X-ray equipment directly in India, regardless of class. They must appoint an Authorized Indian Agent who holds a valid wholesale license (Form MD-42) or manufacturing license, and who files the import application on Form MD-14. CDSCO's Central Licensing Authority reviews the application — with depth proportionate to the equipment's class — and grants the import license on Form MD-15.

Documents Required for MD-14 Application

• Covering letter and duly filled Form MD-14.
• Government fee payment challan.
• Notarized and apostilled Power of Attorney from the foreign manufacturer authorizing the Indian agent.
• Copy of the agent's Wholesale License (MD-42) or Manufacturing License.
• Free Sale Certificate or Marketing Authorization from the regulatory authority of the country of origin.
• Device Master File and Plant Master File of the foreign manufacturing site, including electrical and radiation-safety data appropriate to the equipment's class.
• ISO 13485 certificate and any applicable CE marking or equivalent international approval.

CDSCO Wholesale / Distributor License for X-Ray Equipment (MD-41 & MD-42)

Any business that stocks, exhibits, sells, or distributes X-ray equipment in bulk — including diagnostic imaging equipment distributors and biomedical equipment suppliers — needs a wholesale registration, regardless of the equipment's class. The application is made on Form MD-41, and the State Licensing Authority grants the registration certificate on Form MD-42.

Eligibility and Documents for MD-41/MD-42

• A dedicated storage premise of adequate size with proper shelving, cleanliness, and record-keeping arrangements suitable for sensitive electronic imaging equipment.
• A technically competent person overseeing storage and distribution.
• Duly filled Form MD-41, business constitution proof, premises address proof and layout plan, technical competence proof, and the fee payment receipt.
• A Drug Inspector conducts a physical inspection of the storage premises before the State Licensing Authority issues the registration certificate on Form MD-42.

Fees for X-Ray Equipment Registration

Government fees differ by licence type and risk class, prescribed under the First Schedule of MDR 2017. Class C fees are meaningfully higher than Class A/B, reflecting the deeper technical review involved. Fees are revised from time to time, so always verify the current amount on the SUGAM portal before submitting payment.

Processing Timeline & Validity

As a best practice, begin renewal filing at least 90 days before expiry for Class C X-ray systems, since Central Licensing Authority review depth for imaging equipment can extend the timeline if performance or radiation-safety data needs updating.

Benefits of CDSCO Registration for X-Ray Equipment

• Legal market access: A valid CDSCO authorisation, matched to the correct class, is what allows X-ray equipment to be manufactured, imported, or sold in India.
• Hospital and diagnostic centre procurement eligibility: Government hospitals, diagnostic imaging centres, and procurement tenders require CDSCO documentation before empanelling an X-ray equipment supplier.
• Protection from penalties: Registered businesses avoid the seizure, fines, and legal action that come with selling unregistered medical devices.
• Export credibility: A CDSCO license strengthens your regulatory profile when X-ray equipment is later exported to markets that recognize Indian approvals.

Penalties for Non-Compliance

Manufacturing, importing, or distributing X-ray equipment without the applicable CDSCO authorization is a violation of the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940. Consequences can include seizure of stock, suspension or cancellation of any related licenses, financial penalties, and prosecution under the Act, which in serious or repeat cases can extend to imprisonment. Because X-ray equipment involves ionizing radiation and directly affects diagnostic accuracy, non-compliance in this category is treated seriously by CDSCO, hospital procurement bodies, and radiation-safety regulators alike.

Common Mistakes to Avoid

• Assuming a complete X-ray imaging system qualifies for the lighter Class A/B pathway — most complete systems are Class C and need the MD-7/MD-9 route.
• Applying under the wrong form — filing MD-3 for a Class C imaging system (which needs MD-7), or MD-7 for a Class A/B component (which only needs MD-3).
• Confusing CDSCO medical device registration with AERB radiation-safety clearance — both are required for X-ray equipment, and neither substitutes for the other.
• Submitting an incomplete Device Master File without electrical safety or radiation-performance data.
• Assuming a single license covers manufacturing, import, and wholesale activity — each role needs its own authorization.
• Not verifying the exact device name and variant against CDSCO's most recent radiology classification notice before filing.

Conclusion

X-ray equipment registration in India comes down to one key distinction: are you registering a complete imaging system, or a standalone component? Complete systems — general-purpose, mammographic, fluoroscopic, and dental X-ray machines — are overwhelmingly Class C and require the MD-7/MD-9 route through CDSCO's Central Licensing Authority, while individual components like cassettes and generators are typically Class A/B and follow the lighter MD-3/MD-5 state-level route. Getting that distinction right, and preparing complete electrical safety and radiation-performance documentation from the outset, is what determines how smoothly your registration proceeds.

The team at Silvereye Certifications specializes in end-to-end CDSCO medical device registration support — from device classification and technical dossier preparation to SUGAM portal submissions and post-approval compliance management for X-ray equipment manufacturers, importers, and distributors across India.

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