Shipping FDA-approved Medical Devices
About FDA-approved medical devices
Medical devices are primarily used to diagnose, treat, prevent, cure, or alleviate diseases or conditions. The FDA considers a product to be a device, and subject to FDA regulation if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.
For more information, please visit the FDA website for a detailed description: Click here👈
What types of FDA medical devices can we ship?
Medical devices are classified into Class I, II, and III. The device classification regulation defines the regulatory requirements for a general device type.
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
We currently only support the transport of medical devices in Class I and Class II.
Examples of Commonly Imported U.S. FDA Medical Devices:
- Medical Bandages: gauze bandages, cohesive bandages, tubular bandages, elastic net bandages, waterproof bandages, athletic tapes, etc.
- First And Aid
- Medical Ice Packs
- Adult Diapers: standard adult diapers, pull-up style diapers, underpads, pads/liners, special purpose diapers, etc.
- Medical Wheelchair: manual wheelchair, electric wheelchair, special type wheelchair, etc.
- Beauty Apparatus
Why Choose Us?
- We have more than ten years of experience in the FDA transportation field.
- Full compliance with the transportation of goods, transparent customs clearance process.
- We provide each batch of goods with FDA declaration and release records.
Professional Logistics Experts
We specialize in transporting FDA-approved products to ensure transportation safety.
Choose us for guaranteed FDA transportation from China to the USA.
Full compliance and safety, transparent customs clearance.