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Import Pharmaceuticals & Medical Devices

CDSCO import licences, MDR 2017 device registration, clinical-trial imports and cold-chain clearance — managed end to end.

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The Most Regulated Import Category in India

Drugs, formulations, APIs, medical devices and IVDs are governed by the Drugs & Cosmetics Act and the Medical Devices Rules, 2017 — with CDSCO as the gatekeeper. We manage registrations, import licences and clearance for pharma companies, device manufacturers, CROs and hospitals.

Pathways We Manage

CategoryRequirement
Finished formulationsCDSCO import licence (Form 10 / 10A)
Bulk drugs / APIsForm 10 with product-specific permissions
Medical devices (Class A–D)MDR 2017 registration — risk-class based
In-vitro diagnosticsMDR 2017 IVD pathway
Clinical trial materialRule 30A import permission per study
Lab reagents / reference standardsCase-by-case NOC where not for human use

Our Pharma Import Services

  • CDSCO import licences for drugs and formulations
  • Medical device registration — dossier preparation and CDSCO liaison
  • Clinical trial import permissions coordinated with sponsors and CROs
  • IOR for foreign device companies without Indian entities
  • Cold-chain clearance at Mumbai Air Cargo with temperature integrity
  • Post-approval amendments and licence lifecycle management
Common Questions

Frequently Asked Questions

Do all medical devices need CDSCO registration now?
Under MDR 2017 the vast majority of notified devices require registration, with Class C and D fully mandatory. We confirm the current status for your specific device class before you ship.
Can a foreign device company sell in India without a subsidiary?
Yes — we act as both Authorised Indian Representative for the CDSCO registration and Importer of Record for the physical shipments.
Do you handle clinical trial material?
Yes — Rule 30A import permissions, coordination with the sponsor and ethics documentation, plus the physical import with cold-chain integrity where required.

Ready to Simplify Your Imports?

Tell us what you're importing — we'll respond within 24 hours with a clear assessment and a transparent quote.

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