Medical Device Exports to China: License Guide

Most US-manufactured medical devices can ship to China without a Bureau of Industry and Security (BIS) license, but the exceptions will cost you $364,992 per violation under current BIS civil penalty guidelines (15 CFR 764). The classification work that separates a routine shipment from a compliance disaster takes 15 minutes with the right documentation. Skip it, and you're betting your export privileges on luck.

Key Takeaways

• Medical devices "specially designed for medical end-use" that incorporate CCL-listed items qualify for EAR99 designation and ship to China without a license, provided they don't trigger end-user or end-use restrictions (15 CFR Part 774, Supplement No. 3)
• License applications for CCL items valued over $50,000 require a MOFCOM End-User Statement from China's Ministry of Commerce, with processing averaging 4–8 weeks (15 CFR §748.10)
• BIS added 787 Chinese entities to the Entity List by end of 2023, up from 218 in 2018 (BIS Licensing Strategy Report, 2024)

EAR99 classification: where medical devices fall

The majority of commercial medical devices land under EAR99 designation—subject to Export Administration Regulations but not listed on the Commerce Control List. Under Supplement No. 3 to Part 774, commodities "specially designed for medical end-use" that incorporate CCL-listed components qualify for EAR99 treatment. The exception: components controlled for Nuclear Nonproliferation (NP), Missile Technology (MT), or Chemical & Biological Weapons (CB) reasons.

Here's where SMB exporters get tripped up. That imaging system you're shipping to a hospital in Shanghai might be EAR99, but if it contains a 4A994 computer or 5A992 encryption module, you need to document why the incorporated component qualifies under the medical equipment exception. I've seen classification packages get kicked back three times because the technical specs didn't clearly establish that the controlled component was "essential to the functioning" and "customarily included in the sale" of the medical device.

One rejection was over a missing paragraph. Fixable in an hour, but the resubmission queue added two weeks.

The practical test: Can the medical device function without the controlled component? Is that component normally sold with the device? If both answers are yes, you're likely covered. If not, classify the component separately and check the Country Chart in Part 738.

Military end-user controls: the hidden trigger

EAR99 classification doesn't immunize your shipment from license requirements. Section 744.21 of the EAR imposes license requirements when you have knowledge that items in Supplement No. 2 to Part 744 are destined for a "military end user" in China. This applies regardless of whether your product is EAR99 or carries a specific ECCN.

The definition of "military end user" extends beyond obvious armed forces entities. It includes any party that develops, produces, maintains, or uses military items—which means that a hospital you're shipping to isn't necessarily a safe destination. BIS guidance is explicit: you need to conduct due diligence on whether that hospital serves civilian patients or functions as part of China's national armed services (BIS MEU FAQ, 2021).

A 200-person diagnostic equipment manufacturer learned this the hard way in Q2 2024. They'd shipped patient monitoring systems to what their sales team identified as a "regional medical center." Turned out the facility was affiliated with the People's Liberation Army.

Not worth the savings on the screening check.

The MOFCOM End-User Statement process

When your export requires a BIS license and the total transaction value exceeds $50,000, you'll need your Chinese importer to obtain an End-User Statement from China's Ministry of Commerce. For certain controlled cameras and computers, that threshold drops to $5,000.

The documentation requirements are straightforward on paper: contract details, end-user identification, product specifications, and MOFCOM's official seal. The operational reality is different. MOFCOM processes approximately 500–600 End-User Statements annually for US exporters. Processing times run 4–8 weeks in normal conditions, though the 2025 backlog has pushed some applications past 10 weeks.

Good luck getting status updates during Chinese New Year.

What doesn't work: assuming your Chinese distributor understands BIS requirements. They're juggling NMPA registration, customs declarations, and their own dual-use export controls under China's December 2024 regulations. Your license application sits in MOFCOM's queue while your production schedule burns.

Entity List screening: non-negotiable

BIS processing data from 2018 to 2023 shows that 16% of all license applications for China involved an Entity List party by 2023, compared to less than 1% in 2018 (BIS Licensing Strategy Report, 2024). The license review policy for most Entity List designations is presumption of denial.

Running the Consolidated Screening List before every shipment isn't optional. But single-point screening catches only direct matches. Entity List entries frequently include subsidiaries, affiliates, and predecessor entities that won't surface in a name-only search. Your buyer's parent company could trigger restrictions that don't apply to the purchasing entity directly.

Platforms like Lenzo consolidate OFAC, BIS, and other restricted party lists while surfacing ownership structures that single-list checks miss. For trade compliance operations processing 50+ China shipments monthly, the manual alternative—running separate searches across Treasury, Commerce, and State Department lists—adds 20–30 minutes per transaction.

Timeline reality for China shipments

Build 6–10 weeks into your lead time for any China shipment that might require a license. Standard BIS processing averaged 28 days before 2025, but the internal policy review initiated in February 2025 has introduced delays for applications submitted after that date. Nobody's talking about when that clears up.

The classification decision point happens before the sales contract closes, not when your freight forwarder is asking for documentation. A $75,000 diagnostic imaging system sale that requires an Entity List determination, MOFCOM End-User Statement, and BIS license could easily consume 14–16 weeks from classification to shipment clearance.

That's the real cost of China trade compliance for medical device exporters: not the license fee, but the pipeline delay that turns a Q4 revenue target into a Q1 problem.

FAQ

Do EAR99 medical devices require any export documentation for China?

No BIS license required for most China shipments. But you still screen the end-user against the Entity List and verify no prohibited end-use applies. EEI filing in AES is required for all ECCN items destined for China regardless of license status. EAR99 items shipped NLR skip that particular requirement.

What happens if my Chinese buyer is added to the Entity List after we sign the contract?

Contract date doesn't matter under the EAR. If the entity is listed at the time of export, license requirements apply. Some contracts include regulatory change clauses allowing renegotiation or termination, but the compliance obligation remains regardless of what your legal team negotiated. Check the Entity List designation for specific license exceptions—some listings permit certain categories of exports under license exception provisions, though for China designations since 2022, most carry a presumption of denial.

How do I verify whether a Chinese hospital qualifies as a military end user?

BIS guidance says evaluate whether the hospital is "part of the national armed services" based on its relationship to military entities and patient population served. Hospitals exclusively serving civilian patients generally don't trigger MEU restrictions. But hospitals that serve military personnel, develop military medical capabilities, or report to PLA administrative structures require enhanced due diligence and potentially a license. When in doubt, check if the hospital name contains "解放军" (PLA) or "军区" (military region).