CDSCO Import Registration in India: The Class A and B Equipment Pathway

India is among the largest growth markets for imported hospital equipment, and its import pathway runs through CDSCO, the Central Drugs Standard Control Organisation. Distributors and hospital groups planning Class A and Class B equipment imports, the low- and moderate-risk categories that cover most ward furniture, trolleys and non-sterile equipment, benefit from understanding the registration logic before the purchase order, not after the shipment. This guide outlines the CDSCO pathway for Class A and B equipment, the documents that anchor it, and how exporters and importers divide the work.

Registration requirements differ by market and risk class; the Africa-side certificate package is covered separately in our African tender certificates guide, and India’s system follows its own logic under the Medical Devices Rules. Neighboring market pathways, such as UAE registration, are covered in our UAE medical device registration guide.

How India classifies equipment

parallel registration routes in India

India’s Medical Devices Rules classify devices by risk from Class A, low risk, to Class D, the highest. Much of the equipment a hospital outfitting project needs, ward beds, trolleys, examination lighting, non-sterile furniture-grade items, falls into Class A or B, which places it on the lighter end of the regulatory ladder: Class A devices are registered through a licensing process for import that centers on the manufacturer’s documentation, while Class B adds evaluation of technical documentation. The authoritative source is the CDSCO official portal, where the rules, classification lists and forms are published, and importers should work from the current classification list rather than from a supplier’s description, because classification is determined by intended use and risk, not by what the product is called.

The import registration pathway for Class A and B

Two registrations sit in series. First, the overseas manufacturer holds an import registration or license, obtained through an authorized Indian agent, with the manufacturing site’s quality system documentation, free sale evidence from the home market and device master files in the set. Second, the importer holds its own import license tied to the registered products. Timelines are measured in months rather than weeks, which is the planning fact that changes project schedules: equipment destined for a hospital opening should enter registration early, alongside the order calendar rather than after the factory production slot. Free sale and legalization documents, the same family of paperwork used in other markets, follow the pattern described in our free sale certificate and apostille guide.

Documents that anchor the file

The working set: manufacturer’s quality system certificate, ISO 13485 for most equipment makers; free sale certificate from the country of origin, legalized or apostilled as required; device master documentation describing the product and intended use; the authorized agent appointment for the Indian entity; and labeling that meets Indian requirements. Buyers comparing suppliers should treat these as producible documents, not promises: a factory that ships CE-marked equipment can usually assemble the set, but assembly time belongs on the project schedule, and the certificate package discipline mirrors what we described for African tenders.

Dividing the work between exporter and importer

The manufacturer’s share: quality system certificates, device documentation, free sale evidence, and factory details for the registration. The importer’s share: the Indian entity, the agent appointment, application filings and fees, and labeling localization. A manufacturer such as Sanyang Medical, exporting hospital equipment across five regions with CE and ISO 13485 certification and documentation support built into its product programs, supplies the factory-side set; the importer’s filings remain the importer’s, and starting them early is what keeps a hospital project’s equipment list legal on arrival day.

Video: operating room equipment overview

The overview shows the equipment categories typically covered by Class A and B registrations for hospital projects.

Frequently asked questions