[Sharing] EVERBIZ | Going to the US in Practice
This time it’s not about new regulations – we’re sharing a medical device warehouse in the US.
One of our US clients is a company in the X-ray industry. They have a dedicated medical device warehouse in Cleveland, Ohio, with some space currently unused, and would like to share it by area with Chinese medical device companies that need it. The warehouse also has a lead-shielded room. We thought this might be useful for companies working on the US market, so we’re passing it on.
Exterior of the site buildings
Why It’s Worth a Look
After obtaining FDA (US Food and Drug Administration) market authorization, many companies get stuck at the “landing” stage: where to store goods once they arrive in the US, who handles customs, who acts as importer, and who deals with customer complaints and recalls.
An ordinary third-party logistics warehouse can store goods but is usually unfamiliar with medical device import requirements and unwilling to take on the regulatory responsibilities of an importer. A warehouse run by a medical device company already receives, ships and keeps records according to FDA requirements every day – that is the biggest difference from an ordinary warehouse.
Warehouse Overview
- Area: about 3,800 m² (41,000 sq. ft)
- Location: Cleveland, Ohio, USA (Cleveland, OH 44139)
- Stored goods: mainly large medical and industrial X-ray equipment
- Special feature: a lead-shielded room that can be used for commissioning radiation equipment such as X-ray machines; compliance conditions for shared use are still being confirmed.
Interior: epoxy flooring, yellow-line zoning, office workstations and separate function rooms
Large interior space with ample ceiling height and a gantry crane for moving large equipment
The site photos show several details:
- Epoxy flooring – clean, low dust, with clearly marked zones;
- Separate compartments and function rooms with observation windows, which can be used to separate quarantine, released and isolation areas;
- A gantry crane and handling equipment suitable for large, heavy equipment;
- Several loading docks with door seals and signal lights that connect directly to container trucks.
External loading docks with door seals and red/green signal lights
Interior dock doors and controls
Services Available
1. Customs clearance and import
Assistance with customs formalities for goods entering the US, including cooperation with FDA import review.
2. Warehousing and receiving/shipping
Charged by occupied area, with goods in and out charged per pallet – suitable for stocking and distribution.
3. Acting as Initial Importer
This is the most valuable part of the service – see below.
4. Discounted freight
Discounted freight rates through the company’s existing logistics channels.
Reference Prices
The following are reference quotes provided by the warehouse, in US dollars; actual terms are subject to the signed agreement.
| Item | Price | Notes |
|---|---|---|
| Monthly storage fee | $2 / sq. ft / month | Charged by occupied area – about $21.5 / m² / month; e.g. 100 m² costs about $2,150 / month |
| Receiving/shipping | $25 / pallet | Standard pallets, charged separately for inbound and outbound |
| Other warehouse work | $50 / hour | E.g. unpacking, labeling, counting |
| Initial Importer annual service | $3,000 / year | Includes FDA registration, import/export record keeping, receiving/shipping records and complaint information transfer |
| Routine customs clearance | $200–300 / entry | Depending on the case |
| FDA-related matters | $150 / hour | E.g. handling FDA examinations and holds, coordinating recalls and corrective actions |
What Exactly Is an Initial Importer?
Many companies confuse the US Agent with the Initial Importer, but they are two different roles.
Regulatory requirements
- Definition: An initial importer is an importer who furthers the marketing of a foreign device in the US, distributing or using it – usually the first US company to take possession of the imported goods. (21 CFR 807.3(g); CFR = Code of Federal Regulations)
- Registration: initial importers must register their establishment with the FDA and update it annually; foreign manufacturers must also list their US importers when registering. (21 CFR Part 807; FDA “Device Registration and Listing” page)
- Adverse event reporting: when an importer becomes aware that a device may have caused or contributed to a death or serious injury, it must report to the FDA and the manufacturer; malfunctions must be reported to the manufacturer. (21 CFR 803 Subpart D, e.g. 803.40; MDR = Medical Device Reporting)
- Corrections and recalls: importers have reporting and record-keeping obligations for corrections and removals. (21 CFR Part 806)
So a reliable initial importer is not just “the person who receives the goods” but the one who guards complaints, adverse events and recalls for you in the US. Having a medical device company do this gives more confidence in terms of expertise.
An Extra Hurdle for X-Ray Equipment
In the US, an X-ray machine is not only a medical device but also a radiation-emitting electronic product, subject to the radiation performance standards of the FDA’s CDRH (Center for Devices and Radiological Health).
Regulatory requirements
- Diagnostic X-ray equipment must meet federal performance standards. (21 CFR 1020.30–1020.33)
- When importing electronic products subject to radiation standards, FDA Form 2877 (Declaration for Imported Electronic Products Subject to Radiation Control Standards) must accompany the entry. (21 CFR Part 1005; FDA “Importing and Exporting Electronic Products” page)
Our note (not regulatory text)
Storing, displaying and commissioning X-ray equipment in the US may also involve state radiation safety regulation. The compliance conditions for shared use of the lead-shielded room are therefore still being confirmed by the warehouse; interested companies can register their needs in advance.
Who It Suits
- Companies that have obtained or are applying for FDA 510(k) (premarket notification) or other authorizations and are preparing to stock goods in the US;
- Companies with X-ray machines, DR (digital radiography), CT (computed tomography) and other radiation equipment that need compliant storage;
- IVD instrument and large equipment manufacturers needing a US distribution point or service parts store;
- Companies without a legal entity in the US that need someone to act as initial importer;
- Companies needing only tens to hundreds of square meters that don’t want to lease an entire warehouse.
EVERBIZ Can Help Connect You with Local Resources
When going to the US, product registration is only the beginning – import, warehousing, after-sales and post-market obligations also need someone on the ground. What we value most about this resource is that it “understands medical devices”.
EVERBIZ does not operate this warehouse; our role is to make the introduction and support companies with FDA registration, importer obligations and post-market compliance.
If you’re interested, contact us and we’ll put you in touch
Please briefly state: product type, expected area, whether you need the lead-shielded room, and whether you need initial importer services.
Contact: yuanjiao.huang@everbiz.de
The regulatory content in this article is for reference only and does not constitute legal advice; prices and services are subject to final confirmation by the warehouse.