Military Use of Unapproved Medical Devices: Which Countries Allow It, and Who Holds the Key

Military use of unapproved medical devices is allowed by law in at least eight countries, and in none of them can the manufacturer file for it. If you make a trauma device, such as a hemorrhage-control dressing, a field airway or a resuscitation system, your first serious buyer may be an army rather than a hospital. Armed forces sometimes need these products before civilian approval is in hand, and several governments have written rules that let them. The catch is who those rules are written for.

We read the laws and regulations themselves in more than 40 countries and the EU, as of November 2, 2026. Here is where a military route exists, who controls it, and what that means for a company with a device that is not yet approved. For every market, including who would decide if war broke out there, see our military and emergency device access list across 41 markets.

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Countries with a military route, at a glance

These routes are moving. Australia's opened in September. When the next one changes, it will be in our monthly email. Email Tell me

Australia: a new Defence exemption (September 2026)

Since September 8, 2026, Australia's medical device regulations exempt devices from inclusion on the Australian Register of Therapeutic Goods (ARTG) when they are manufactured in Australia for the Defence Department, imported or exported for it, or supplied for it or by a Defence medical practitioner. The change is item 2.20 of Schedule 4, added by an amending regulation dated September 3, 2026. It covers medicines too, through a parallel change to the medicines regulations.

The exemption comes with five conditions:

• A Defence doctor directs use. The device is used by, or on the direction of, a Defence medical practitioner.
• A committee approves it first. Before the device is used on anyone, a Defence clinical governance committee must consider it appropriate.
• Defence keeps custody. The device stays with the Defence Department from the moment it takes possession until use or disposal.
• Defence keeps records of each device, its manufacturer and sponsor, and the quantity.
• TGA can see them. Defence must hand the records to the regulator on request.

This is genuinely new. Before September, the only Defence-related exemption in those regulations covered visiting foreign forces training in Australia, and only for their own members or the Australian Defence Force. For a company outside Australia, the practical meaning is simple: the decision sits with Defence's clinical governance committee, not with TGA.

United States: the law covers devices, the declarations so far do not

Section 564 of the Federal Food, Drug, and Cosmetic Act lets FDA authorize emergency use of an unapproved "drug, device, or biological product". In 2017, Public Law 115-92 added a military trigger that goes beyond chemical, biological, radiological and nuclear threats: a determination by the Secretary of Defense of a military emergency involving an agent that may cause "an imminently life-threatening and specific risk to United States military forces". In that case, the request for emergency use must come from the Secretary of Defense.

We found two declarations made on this ground:

• 2018, hemorrhage. On June 7, 2018, the Deputy Secretary of Defense determined that deployed forces faced combat casualties with uncontrolled hemorrhage from firearms, projectiles and explosive devices. HHS declared on July 9, 2018, for freeze-dried plasma. FDA has since authorized freeze-dried plasma products under it, including one in August 2024.
• 2026, acute pain. On July 15, 2026, the Secretary of War (the title used in the notice) made a new determination. HHS declared on August 31, 2026, for drugs to manage moderate to severe acute pain in casualties.

Here's the catch. Neither declaration covers a device. A trauma device would need a new determination and declaration that reach it, and only the Pentagon can start that.

The more realistic US door is faster review. The same 2017 law lets the Secretary of Defense ask FDA to expedite a medical product's development and the review of its investigational device exemption (IDE), 510(k) or PMA when there is a specific, imminently life-threatening risk to US forces. FDA must then act, which can include regular meetings with the sponsor, senior reviewers, a cross-disciplinary project lead and help making the clinical trials as efficient as practicable. The end point is an ordinary clearance or approval, reached sooner.

Separately, a physician can use an unapproved device in a single life-threatening emergency without FDA's prior approval, if no alternative exists and there is no time to seek it, and FDA must be told afterwards. That helps one patient. It is not a way to supply an army.

Germany: the Defence Ministry grants the EU exemption

The EU Medical Devices Regulation has no armed-forces exemption. Its only military reference lets member states keep extra protections for people doing compulsory military service who take part in clinical investigations. What it does have is Article 59: any national authority may authorize a specific device that has not been through conformity assessment, "in the interest of public health or patient safety or health", within its own territory.

Germany gives that power to the military. Under §90(3) of the Medical Devices Law Implementation Act (MPDG), the Federal Ministry of Defence grants Article 59 special approvals (and the equivalent for IVDs) when the device is to be used for special tasks of the Bundeswehr, and it informs the European Commission and the other member states itself. Inside the Bundeswehr, its own bodies enforce the device rules.

France: the Minister of Defense can use a device without its certificate

France wrote a military route into its Public Health Code. Under Article L.5211-3 IV, the regulator, ANSM, may authorize the Minister of Defense to use a medical device and its accessories even though they lack the conformity certificate the EU MDR requires, when no suitable device is available and the use meets specific national-defense needs. It covers devices made by the armed forces health service (SSA), devices made to the ministry's order, and devices the ministry imports. Article L.5221-3 IV does the same for IVDs.

On August 16, 2026, the military programming law widened it: devices made to the ministry's order may now be distributed by any entity of the armed forces health service, not only its supply depots. In a chemical, biological, radiological or nuclear crisis, the health service can also hand these devices to other ministries.

Switzerland and Spain: two narrower routes

• Switzerland. The Medical Devices Ordinance (Article 22(3)) lets the Interior Department, in agreement with the Defense Department, grant exemptions for devices placed on the market only within the Army or for its special tasks. The text sets no further conditions. Separately, Article 22(2) lets a doctor use a single non-conforming device on a patient in a life-threatening condition, without asking anyone, if no conforming device exists and the patient consents.
• Spain. A 2020 royal decree on medicines and devices in the armed forces lets the Defense Health Inspectorate authorize devices without CE marking for Spanish military health facilities outside Spain, if they are legally sold in another country and no suitable alternative can be supplied from Spain. A device approved nowhere does not qualify.

Ukraine: named military grounds, applied for by the state

Health Ministry Order No. 2462 of October 29, 2020 sets out when devices that do not meet Ukraine's technical regulations may be put into use, without the right to sell them on. Two of its six grounds are military: medical support of service members, police and others performing national security and defense tasks during martial law, a state of emergency or a "special period"; and medical support of foreign armed forces admitted to Ukraine.

The applicant is a ministry, another central or local government body, or an individual. The Ministry decides within ten working days, free of charge. A manufacturer reaches this route through a Ukrainian government customer, not on its own.

Israel: army orders

Israel's Medical Equipment Law of 2012 binds the state, but section 20(b) carves out the Israel Defense Forces. The IDF's manufacture, marketing, possession and use of medical equipment that would otherwise need registration are governed by army orders, provided those orders ensure the benefit to patients outweighs the risk.

Close to a military route

Several countries do not name the military, but have a government or emergency route a defense medical service could use. That use is our reading where the text does not say so.

• Thailand. State agencies, including government hospitals, may make, import or sell devices without registration for diagnosis and treatment (Medical Devices Act, section 27(1)).
• Saudi Arabia. SFDA may waive marketing authorization in "public emergencies such as natural disasters, wars, or epidemics".
• Brazil and Mexico. Brazil's hospital import rule lists "military organizations" among the importers that may bring in unregistered products, with Anvisa's approval. Under a December 2024 rule, Mexico lets devices cleared by FDA, the European Commission and eight other authorities enter unregistered for consolidated public-sector purchases whose buyers include the Navy's health system. The supplier must file for registration within 10 working days of the first import.
• Japan. In an armed attack, the health ministry can grant special import approval for devices needed to treat evacuees.

Where there is no military route

• United Kingdom. The UK's device regulations contain no armed-forces provision. A manufacturer can apply to the MHRA to supply a non-UKCA-marked device to protect a patient's health when no legitimate alternative exists. That is a patient route, not a military one.
• South Korea. Emergency use approval under the special act on public-health crisis medical products covers devices, but a crisis there means a pandemic, the use of biological or chemical weapons, or a nuclear or radiological emergency. Battlefield trauma is not a trigger.
• Most of the rest of the EU. Article 59 is available, but through health authorities, on public-health grounds. Italy, Poland, Finland and Romania have no armed-forces carve-out.

What this means if you make a trauma device

• Sell to the medical service, not the regulator. Every military route above is opened by the buyer: a defense ministry, a clinical governance committee, the armed forces. Your job is to give them a file they can approve, with your quality system, bench data and any clinical evidence.
• Start where the door is newest or clearest. Australia's exemption is explicit, recent and run by a named committee. In Europe, France's route names the Minister of Defense outright.
• In the US, aim for clearance, faster. Ask whether the device answers a risk that would justify a Pentagon request for expedited review of your IDE, 510(k) or PMA.
• Keep the civilian file moving. A military route gets the device to soldiers, not to the hospital market. Australia's exemption covers Defence use only, and Ukraine's clearance carries no right to sell on.

A worked example. Say you make a hemorrhage-control device with no FDA clearance and a CE certificate still in review. In Australia, the Defence Force could use it under item 2.20 once its clinical governance committee approves it, with no ARTG entry. In Germany, the Bundeswehr would need the Defence Ministry's Article 59 approval. In the US, the faster door is not an emergency use authorization but a Pentagon request that FDA expedite your 510(k). In each case, the conversation that matters is with the defense medical service.

Frequently asked questions

Can a manufacturer apply for military use of an unapproved device?

Not in the countries we read. In Australia, the US, Germany, France, Switzerland, Spain, Ukraine and Israel, the armed forces, a defense ministry or another government body starts the route. The manufacturer supports the application.

Does the US allow emergency use authorization of devices for the military?

The law does: since 2017, a Secretary of Defense determination of a specific, imminently life-threatening risk to US forces can support emergency use of a drug, device or biological product. The two declarations we found on that ground, from 2018 and 2026, cover freeze-dried plasma and pain drugs, not devices.

What changed in Australia in 2026?

From September 8, 2026, devices manufactured, imported or supplied for the Defence Department are exempt from ARTG inclusion, provided a Defence clinical governance committee approves each device before use and Defence keeps custody and records.

Does the EU MDR exempt military devices?

No. Article 59 lets a national authority authorize a specific device in the interest of public health. Germany gives that power to its Federal Ministry of Defence for the Bundeswehr's special tasks, and France lets its regulator authorize the Minister of Defense to use a device that lacks its MDR certificate for specific national-defense needs.

Which countries have a military route for unapproved medical devices?

Of the more than 40 countries we read, eight have a written route that names the military: Australia, the United States, Germany, France, Switzerland, Spain (for its forces abroad), Ukraine and Israel. Brazil, Mexico and Vietnam name the military inside broader routes. Our full list covers 41 markets.

The short version

Military routes for unapproved devices exist in Australia, the US, Germany, France, Switzerland, Spain, Ukraine and Israel. Each one is held by the military or the state. Your regulator is still the regulator, but your first approver may be a defense medical service.

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Sources, read on November 2, 2026: Australia, Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 4 Part 2 item 2.20, inserted by F2026L01167 (dated September 3, 2026), and the compilation in force on July 1, 2026; United States, 21 U.S.C. 360bbb-3 (FD&C Act §564) and 360bbb-3c, as amended by Public Law 115-92 (2017); FDA notice FR Doc. 2018-17303 (freeze-dried plasma); HHS notice FR Doc. 2026-18008 (September 3, 2026); FDA, Expanded Access for Medical Devices; Regulation (EU) 2017/745, Articles 59 and 67 (consolidated text); Germany, Medizinprodukterecht-Durchführungsgesetz §90; Ukraine, Ministry of Health Order No. 2462 of October 29, 2020; Israel, Medical Equipment Law 5772-2012, section 20; United Kingdom, Medical Devices Regulations 2002 and MHRA guidance on exceptional use of non-UKCA-marked devices; South Korea, Special Act on Public Health Crisis Medical Products, Articles 2 and 12; France, Code de la santé publique L.5211-3 and L.5221-3, as amended by Loi n° 2026-791 of August 16, 2026, Article 24; Switzerland, Medical Devices Ordinance (SR 812.213) Article 22; Spain, Real Decreto 1155/2020, first additional provision; Thailand, Medical Devices Act B.E. 2551, section 27; Saudi Arabia, Implementing Regulation of the Medical Devices Law, 8.3; Brazil, Anvisa RDC 488/2021, Article 1; Mexico, Acuerdo of December 4, 2024 on import permits for public-sector supply; Japan, Civil Protection Act, Article 92. This is a summary for planning, not legal or regulatory advice; check the current instrument before acting.