An Indian licence number on the label
Most medical devices brought into India need an import licence in Form MD-15. Only an Indian agent authorised by the maker can hold one. The label must then show that licence number and the importer's name and address, added by sticker where they are not printed. X-ray adds a second gate, as the user needs AERB permission before it buys and may buy only type-approved units from authorised suppliers.
We're MediGear, the medical equipment distributor behind this page, with our company registered in England and Wales. Healthcare buyers in more than 80 countries rely on us for quotes, documents and freight. Name the model, or describe what you need, from diagnostic imaging equipment to patient monitors. We look for verified makers whose Indian agent holds the licence. Then we check the points on this page before your engineers and purchase team see the quote. Requests reach us through our buyers page, with no account to open.
Central institutes, private groups and mission hospitals
Requests come from across India's healthcare system, including central institutes, state systems and private groups:
- AIIMS and other New Delhi hospitals, plus JIPMER
- The newer AIIMS, six of them fully running, with Madurai, Rewari and Darbhanga still being built
- Tata Memorial Centre's cancer hospitals in Mumbai and other cities
- Private groups such as Apollo, Max, Fortis and Narayana Health, which can browse our cardiology equipment
- CMC Vellore, a mission hospital whose new Paediatric Speciality Centre at Ranipet held a block inauguration on 1 October 2026
- Hospitals on the AB PM-JAY panel, which gives cashless care at public and private hospitals
- Indian distributors and authorised agents that hold MD-15 import licences
Government hospitals and other government users must buy through GeM, the state's online market, for the goods it lists, under Rule 149 of the 2017 General Financial Rules. Central bodies also publish tenders on CPPP, the central government's tender site, which lists global tenders. In India's public health system, CMSS is the health ministry's central procurement agency, and states run their own buying bodies, such as TNMSC in Tamil Nadu. A private clinic buying one ultrasound unit follows none of these routes, though the model still needs its licence.
CDSCO, Form MD-15 and the authorised agent
CDSCO, the Central Drugs Standard Control Organisation, regulates all medical devices under the Drugs and Cosmetics Act 1940 and the Medical Devices Rules 2017. The import licence is applied for online in Form MD-14, through CDSCO's online system for medical devices or the National Single Window System. Only an authorised agent, appointed by the overseas maker through a power of attorney, can apply, and it must hold a licence to manufacture or wholesale devices, or an MD-42 registration.
A temporary exemption once allowed registered devices to be sold without a licence, but it has ended for every risk class. CDSCO decides on an MD-15 application within nine months, and its online list of approved devices shows what is already covered. If a model has no licence, the maker's agent must get one before the model can come in. We cannot hold or apply for that licence, as we are not an authorised agent in India, and nothing here is regulatory advice.
AERB permission before an X-ray purchase
The Atomic Energy Regulatory Board (AERB) licenses medical X-ray equipment through its eLORA system, under the Atomic Energy Act 1962 and the radiation protection rules of 2004. Before buying, the user must get AERB permission to procure. It may then buy only type-approved or NOC-validated models from authorised suppliers, as set out in AERB's guidance for new X-ray facilities. Diagnostic imaging systems in India fall into two AERB categories: CT and interventional work in the licence category, and other diagnostic X-ray in the registration category. Send the model number, and the quote states its AERB status.
No diagnostic X-ray unit may be used on patients until its licence for operation is in place. Walls, doors, ceiling and floor need shielding, and a CT console must sit in a separate room. Each X-ray department needs a safety officer approved by AERB, and quality checks by an authorised agency follow at least once every two years and after any repair that affects radiation safety.
Type D and M sockets, reports and records
Before quoting, we put four questions to the maker:
- Three plug types. The IEC lists type C, D and M plugs for India on 230 V and 50 Hz, with type M for larger units. A unit built for 110 V or 60 Hz needs a different factory build.
- Reports for AERB.An AERB-authorised agency does QAy, so agree early which agency will do it and who will service the unit.
- Spares. Ask how the maker's Indian agent supports wear parts, and whether spare parts and consumables can be included in the first order.
- Record links. ABDM, the national digital health mission, links patient records, so check DICOM and HL7 with your IT team.
Anything still open goes to the maker in writing, because the label must show the import licence number and the importer's details.
ICEGATE filing and plant quarantine
CBIC, India's customs board, runs customs, and declarations are filed online through ICEGATE. Device imports clear at ports notified by CDSCO, which has mapped them to ICEGATE. The file sent with each order holds:
- Commercial invoice and packing list
- A certificate of origin, where it is needed
- HS codes, line by line
- A copy of the MD-15 import licence held by the maker's agent
- Labels that show the import licence number and the importer's details
Wood packing must meet ISPM 15 under the Plant Quarantine Order of 2003. It must carry the treatment mark or travel with an endorsed plant health certificate, as recorded in customs standing orders at Nhava Sheva. Customs inspects wooden packing, and anything unmarked goes to the Plant Quarantine Officer for treatment, destruction or return.
Nhava Sheva, Mundra or Chennai
- Open with the model. Tell us the model, quantity and site through the RFQ form or by email. For portable X-ray machines or any other X-ray unit, add your AERB procurement permission.
- Check the licence line. For catalogue items, the quote usually comes within 48 hours and shows the MD-15 status, certification, lead time and port.
- Approve before we order. Only your written approval, by email or letter, sends the order to the maker.
- Sea and air routes. Sea freight into JNPA at Navi Mumbai, Mundra in Gujarat or Chennai, or air freight into Delhi's IGI Airport, whose cargo terminals have cold storage.
We ship the units and any medical equipment supplies on the order to the port or airport you nominate. From there, the goods are cleared through the customs system, and the onward leg to the hospital is arranged on your side. Tell us early if the site is far inland so we can plan the road leg with the sea crossing.
New units first, with limits on used ones
A district clinic needing one monitor or an item of hospital furniture can order just that, as single units are normal on most catalogue lines. Larger public projects are quoted as multi-line requests; see government tender for GeM and CPPP work, and hospital labs can browse Lab, Pathology and Blood Bank for laboratory equipment in India. Our refurbished range covers pre-owned units, but refurbished medical equipment in India faces tight import controls. Used critical-care equipment cannot be imported for re-use, and listed high-end used equipment needs MoEFCC permission through the National Single Window System. That route asks for at least seven years of residual life, the maker's backing for spares, and a one-year warranty followed by three years of maintenance. A pre-owned X-ray unit more than seven years old may not be importable, so we check the status with you before quoting refurbished medical devices in India.
Disclaimer
This page offers general information for buyers in India and is not an offer to supply. Do not rely on it as legal, regulatory or customs advice. Every quote depends on what makers can supply, and an order stands only when both sides have agreed it in writing. Imported devices need an MD-15 licence held by the maker's Indian agent, and X-ray units need AERB permission before purchase and a licence for operation before use. Import clearance and your regulatory position sit with you and your importer, since we are not an Indian importer, licence holder or authorised agent.
Has AERB cleared the purchase?
For an X-ray unit, AERB permission to procure comes first, and only type-approved models may be supplied. Send the model number or a data sheet with your permission details, and we'll quote with the licence route, the CE file and the sea leg.
Frequently Asked Questions
The model number or specifications are enough; email connect@medigear.uk or use the RFQ form on the buyer's page, and no account is needed. We quote for AIIMS institutes, state hospitals, private groups, mission hospitals and lab equipment suppliers. Indian distributors, including medical equipment suppliers in Delhi, can send the same.
For anyone in medical device distribution, the import licence comes first. An Indian authorised agent, appointed by the overseas manufacturer through a power of attorney, applies for the MD-15 licence in Form MD-14 through CDSCO's online system for medical devices. The agent must hold a manufacturing or wholesale licence or an MD-42 registration.
The import licence number and the importer's name and address, along with the manufacturing site address and date of manufacture, added by sticker where they are not printed. We check these details with the maker's agent before we quote.
Yes, for diagnostic imaging devices that use X-ray. The user gets AERB procurement permission first and may buy only type-approved or NOC-validated models from authorised suppliers. A licence for operation is then needed before any patient use, and quality assurance follows at least once every two years.
For medical equipment supply in Delhi, air freight goes into IGI Airport, and sea freight can go into JNPA at Navi Mumbai, Mundra in Gujarat or Chennai. Clearance and the onward leg are arranged on your side once the unit reaches the port or airport you nominate.
Customs is run by CBIC, with electronic filing through ICEGATE, and device imports clear at ports notified by CDSCO. We send the commercial invoice, packing list, origin papers, HS codes and a copy of the MD-15 licence with each consignment.
Yes. One unit is a normal request on most catalogue lines, and any minimum order a maker sets comes up in our first reply. The model still needs its MD-15 licence through the maker's agent, which we confirm before quoting.
Licences come first. If the maker's agent still needs an MD-15 for the model, CDSCO has up to nine months to decide, and X-ray also needs AERB procurement permission. Stock and the sea leg add to that, and each quote states the lead time and route.