Regulatory and commercial legal for foreign medical-device companies in India.
A foreign medical-device company can invest one hundred percent in India under the automatic route, but market access runs through the Medical Devices Rules 2017 and the CDSCO, which classify devices by risk and impose registration, import-licensing, and quality obligations accordingly. The regulatory status of a device, Class A to Class D, determines the licensing path, the clinical-evidence expectations, and the compliance burden, and the regime has progressively brought more device categories into mandatory regulation.
Beyond registration, the company must address import licences, an authorised Indian agent, labelling, post-market surveillance, and the distribution and channel arrangements through which the device reaches hospitals and patients. We classify the device and map the regulatory pathway, manage the CDSCO registration and import licensing, appoint and structure the authorised-agent relationship, and build the distribution, pricing, and post-market compliance so the product reaches the market lawfully.
Classifying the device under the risk-based Class A to D framework, which governs the registration and licensing pathway.
Managing device registration, import licensing, and the quality and documentation requirements with the CDSCO.
Structuring the authorised Indian agent and the agency agreement that supports the import and regulatory position.
Building labelling, vigilance, and post-market-surveillance compliance under the Medical Devices Rules.
Structuring the one hundred percent FDI, holding structure, and FEMA reporting.
Negotiating distribution and channel agreements and addressing any price-control exposure for notified devices.
Yes. Medical devices allow one hundred percent foreign investment under the automatic route. The gating issue is regulatory market access through the CDSCO under the Medical Devices Rules 2017, not the FDI approval.
Under the Medical Devices Rules 2017, devices are classified by risk from Class A to Class D, and the class determines the registration, import-licensing, clinical-evidence, and quality obligations administered by the CDSCO. More categories have progressively been brought into mandatory regulation.
Yes. Import and registration generally require an authorised Indian agent holding the appropriate licence, who carries regulatory responsibilities. Structuring this relationship correctly is central to a compliant import and distribution model.
No. No engagement is treated as accepted until conflicts, scope and terms are confirmed in writing. An initial discussion is confidential and is used only to understand the matter and assess fit.
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