Medical Equipment

You import medical equipment for reasons that go beyond a simple balance sheet.

It's about the standard of care. You import because a specific diagnostic machine or surgical tool is essential for providing quality treatment. It's a necessity, not a choice.

You need the best technology. The best medical technology is global. To offer cutting-edge diagnostics or treatments, you have to source equipment from the best manufacturers in the world, wherever they may be.

Compliance is non-negotiable. This isn't about avoiding fines; it's about ensuring a device is legally approved and safe for use on Indian patients. CDSCO compliance is your ethical and legal responsibility.

A delay is a disruption to healthcare. A hospital can't function if a new MRI machine or a batch of critical instruments is stuck at the port. A delay in this sector isn't an inconvenience; it's a direct disruption to patient services.

The process for importing medical devices is rigid, unforgiving, and leaves zero room for error.

Identify the Equipment Required. Know the exact specifications and brand you need.

Supplier and Sourcing. Ensure your supplier can provide all the necessary international certifications, like CE or FDA approval. This is your first layer of due diligence.

Regulatory Approval and Classification. This is the most critical hurdle. Before you even think about shipping, you must know the CDSCO risk class (A, B, C, or D). This determines everything. You will need an Import License (Form MD-15) from CDSCO before the goods can be dispatched.

Import Documentation Preparation. Every document—invoice, packing list, certificate of origin—must match the CDSCO license details perfectly.

Customs Clearance. You file the Bill of Entry, but it's not a standard filing. It must be accompanied by the CDSCO import license and other regulatory documents.

Inspection and Quality Checks. Expect scrutiny. Customs and CDSCO have the right to inspect and draw samples to verify that what's in the box is exactly what you declared and that it meets all Indian quality standards.

Transportation to the Facility. This requires care. Sensitive medical equipment can be easily damaged.

Post-Import Regulatory Compliance. Your job isn't done when the machine arrives. You have post-market surveillance duties. You are responsible for tracking the device and reporting any adverse events to CDSCO.

Installation and Maintenance. Proper installation and calibration by certified engineers is the final step to ensuring the device is safe and effective for use.

Think of this as the complete medical file for your shipment. Every piece of paper must be perfect.

• The Import License (MD-15) from CDSCO. This is your entry ticket. Without it, the shipment will not be cleared.
• CE Certificates or FDA Approvals from the country of origin.
• The standard set: Commercial Invoice, Packing List, Bill of Lading / Airway Bill.
• A Certificate of Origin if you're claiming any duty benefits.
• The filed Bill of Entry (BoE).
• User manuals and technical specifications.

• CDSCO Approval and Licensing: CDSCO runs the show. Period. You must follow their risk-based classification system. Each class has a different, mandatory set of rules for licensing, labeling, and registration.
• Customs Duty and GST: While duties and taxes apply, the government sometimes offers duty exemptions for equipment used for charitable hospitals or for research and development. But you have to prove it with extensive documentation.
• Certification and Labeling Requirements: The labeling on the device must comply with Indian Medical Device Rules. This is a common point of failure.
• Inspection and Compliance: Don't be surprised if your shipment is flagged for inspection. They will check everything—from the labeling on the box to the technical specifications of the device itself.
• Post-Import Registration: Even after clearance, some devices must be formally registered in CDSCO's online portal to ensure they can be tracked while in use in the country.

Our job in this high-stakes process is to manage the entire regulatory burden for you.
We handle the complex CDSCO licensing process before you even place the order. We ensure every document submitted to customs is perfectly aligned with the CDSCO approval. We coordinate with the officers during an inspection. We don't just move a box; we manage the compliance that allows that box to be used safely and legally in India.

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