Where an armed force or an emergency can open a door for a device that is not yet approved, who holds the key, and who would buy if war broke out. 41 markets, read at each authority's own text, as of November 2, 2026.
Military and emergency access to unapproved medical devices is possible in most of the 41 markets on this page, but a route written for the armed forces exists in only 7 of them. If you make a trauma or field-care device, that difference decides who you talk to first. Where the law names the military, the defense ministry or the armed forces' medical service holds the route. Everywhere else, an emergency or government route may let a military hospital bring your device in, but it was written for something else.
Key takeaways
Each market sits in one of five groups. Click a market to jump to its card.
Military route 7 markets. A written route that names the armed forces or the defense ministry and gives access to devices that are not approved.
United States, Germany, France, Switzerland, Spain, Israel, Australia
Military named, narrower 4 markets. The military is named, but as one applicant in a general route, or for something narrower than access.
Emergency or government route 26 markets. No military wording, but a government, emergency or exceptional route a military hospital could use. That use is our reading.
Canada, Colombia, Argentina, Peru, Chile, Costa Rica, European Union, Italy, Poland, United Kingdom, Saudi Arabia, United Arab Emirates, Egypt, Nigeria, Kenya, Ethiopia, Botswana, Japan, South Korea, Taiwan, Singapore, Malaysia, Thailand, Indonesia, Philippines, India
Little premarket barrier 3 markets. Most devices need no premarket approval today.
Closed 1 market. Supply to the armed forces is barred or licensed under sanctions.
The law on the books in peacetime is not the whole story. When full-scale war began in February 2022, Ukraine's Health Ministry waived its device conformity rules for a time, then withdrew the waiver. Its standing rules still let a ministry or other state body apply for devices that do not meet Ukraine's technical regulations, for military personnel during martial law, a state of emergency or a "special period". The buyer changed too: since January 1, 2026, the Defense Ministry's Defence Procurement Agency (DOT) has been the single procurer for the army, including medical property, while a separate state enterprise buys for the Health Ministry.
Three things tend to happen when a country goes to war, and they are why each card below lists a wartime buyer and decision maker:
We do not predict conflicts. We record the legal machinery, so that if one starts you know where the decision sits.
Route today. Emergency use authorization on a Secretary of Defense determination of a specific, imminently life-threatening risk to US forces; and Defense-requested expedited FDA review of IDEs, 510(k)s and PMAs. No declaration on the military ground covers a device yet (2018: freeze-dried plasma; 2026: pain drugs).
Who applies and decides. The Secretary of Defense requests; HHS declares; FDA authorizes
If war broke out: who buys. The Defense Health Agency runs military medical facilities; the Defense Logistics Agency is the Defense Department's executive agent for medical materiel.
If war broke out: who decides. FDA, through a §564 emergency use authorization that starts with a Secretary of Defense determination. The Defense Production Act can prioritize and allocate supply of devices, but does not replace FDA clearance.
Source: 21 U.S.C. 360bbb-3(b)(1)(B)(ii) and 360bbb-3c (Public Law 115-92, 2017); 10 U.S.C. 1073c; Defense Production Act, 50 U.S.C. 4511
Route today. Special Access Program: a device not licensed in Canada can be supplied for emergency use or when conventional therapies have failed or are unavailable. No defense provision in the regulations.
Who applies and decides. A health care professional applies; Health Canada decides
If war broke out: who buys. Canadian Forces Health Services, which runs a strategic stockpile of medical products; Public Services and Procurement Canada holds the statutory authority to buy defense supplies.
If war broke out: who decides. Health Canada. In a declared war emergency, the government may make any order it considers necessary; the Health Minister can also make interim orders under the Food and Drugs Act without a war.
Source: Medical Devices Regulations, SOR/98-282, sections 69 to 72; Emergencies Act, Part IV; Food and Drugs Act s.30.1; Defence Production Act s.10
Route today. Devices cleared by FDA, the European Commission or eight other named authorities may be imported unregistered for consolidated public-sector purchases whose buyers include the Navy's health system (the Defense ministry is not named). The supplier must file for registration within 10 working days of the first import.
Who applies and decides. The supplier applies to COFEPRIS
If war broke out: who buys. The Army and Air Force health service (Sanidad), buying through the Defense ministry's health acquisitions section; the Navy's health system buys through consolidated public-sector purchases. Military purchases may skip public tenders.
If war broke out: who decides. COFEPRIS. The constitutional emergency power is general; no war law names devices.
Source: Acuerdo on import permits to guarantee public-sector supply, Diario Oficial, December 4, 2024, Articles 1, 2, 6, 8; Ley Orgánica del Ejército y Fuerza Aérea Arts. 90-91; Ley de Adquisiciones 2025 Art. 54; Constitution Art. 29
Route today. "Organizações militares" are listed among the bodies that may import products for a linked health unit's own use. An unregistered product needs approval by Anvisa's board and must be unavailable in Brazil. The rule speaks of products under health surveillance; it does not say "device".
Who applies and decides. The military organization applies; Anvisa's board decides
If war broke out: who buys. Each force buys for its own health units through its health directorate and contracting units; we found no single defense medical buyer.
If war broke out: who decides. Anvisa's board. A war-time siege decree or the national mobilization law can add requisition and redirected production. In 2020 a COVID statute let health products be imported without Anvisa registration, a precedent but not standing law.
Source: Anvisa RDC 488/2021, Articles 1 and 4; Constitution Arts. 137-139; Lei 11.631/2007 (Mobilização Nacional); Lei 13.979/2020 (precedent)
Route today. INVIMA may exceptionally authorize import without registration in a calamity or emergency declared by the health ministry, among other cases. The application needs a free-sale certificate from the country of origin, so a device approved nowhere does not qualify.
Who applies and decides. The importer applies; INVIMA decides
If war broke out: who buys. The Dirección General de Sanidad Militar, which administers the military health system's funds, and each force's health directorate.
If war broke out: who decides. INVIMA, once the health ministry declares an emergency. In a declared external war, the government's decrees can suspend incompatible laws and order expropriation for the war's needs.
Source: Decreto 4725 de 2005, Article 48; Ley 352/1997 Arts. 9-11; Constitution Art. 212; Ley 137/1994 Art. 26
Route today. Compassionate use of a device for one patient at a time. A device approved nowhere must be in a controlled trial with a published clinical study. No disaster or emergency device import route found.
Who applies and decides. The treating physician applies; ANMAT decides
If war broke out: who buys. Each force's contracting directorate, which can buy by emergency direct contracting.
If war broke out: who decides. ANMAT. The defense law lets the government requisition goods in war or its imminence; we found nothing that lets ANMAT's registration be set aside beyond single-patient use.
Source: ANMAT Disposición 3315/2005 (whether still in force is not confirmed); Ley 23.554 de Defensa Nacional Art. 34
Route today. Exceptional import authorization without registration for use in a declared urgency or emergency, for research and training, for individual treatment, or where a product is needed and unavailable.
Who applies and decides. DIGEMID decides
If war broke out: who buys. The Agencia de Compras de las Fuerzas Armadas, the Defense ministry's purchasing agency for the joint command and the three forces.
If war broke out: who decides. DIGEMID, through provisional authorization once an emergency or siege is declared. The mobilization law allows requisition (its current status is not confirmed).
Source: Ley 29459, Article 16; Decreto Legislativo 1128; Constitution Art. 137; Ley 28101
Route today. The ISP director may authorize provisional sale or use of devices without conformity checks in a national emergency or urgent need. Most device types need no registration at all, but a 2026 decree is bringing 39 more types under control in phases.
Who applies and decides. The ISP director decides
If war broke out: who buys. The forces' logistics and supply directors, who hold purchasing power under the armed forces' procurement law.
If war broke out: who decides. The ISP director, under the national-emergency authorization. A state of assembly in foreign war lets the President requisition goods, and he may delegate to armed forces commanders.
Source: Decreto 825/1998, Article 4; Decreto Exento 25/2026; Ley 18.928; Constitution Art. 43; Ley 18.415 Arts. 2, 17-21
Route today. In urgency or public need, the health ministry may authorize a health provider to import and use unregistered devices, deciding within 10 days. Costa Rica has no army.
Who applies and decides. The health provider applies; the Ministry of Health decides
If war broke out: who buys. No army. In a declared emergency, the national emergency commission (CNE) takes single command and buys outside ordinary procedure; war is an express trigger.
If war broke out: who decides. The Ministry of Health, under its 10-day urgency authorization. Whether the emergency regime reaches device registration is unclear.
Source: Decreto 34482-S, Article 19; Ley 8488 Arts. 4, 31-33
Route today. No military exemption anywhere in the MDR. Each member state may authorize a specific device that has not been through conformity assessment, in the interest of public health or patient safety. The only military reference protects conscripts in clinical investigations.
Who applies and decides. The national authority of each member state
If war broke out: who buys. No EU body buys medical materiel for national armed forces; each member state buys for its own.
If war broke out: who decides. Each member state's national authority under Article 59. The EU-wide emergency authorization the Commission proposed in December 2025 would apply only to biological, chemical, environmental or unknown-origin health threats, not conventional battlefield trauma.
Source: Regulation (EU) 2017/745, Articles 59 and 67; Regulation (EU) 2022/2371; COM(2025) 1023 (proposal)
Route today. The Federal Ministry of Defence grants Article 59 special approvals (and the IVD equivalent) for devices used for special tasks of the Bundeswehr.
Who applies and decides. The Federal Ministry of Defence
If war broke out: who buys. The Bundeswehr's Kommando Gesundheitsversorgung (its procurement organization in Koblenz) buys medical materiel centrally, with the Bundeswehr's infrastructure and services office as contracting authority.
If war broke out: who decides. The Federal Ministry of Defence, under MPDG §90(3). In a state of defense, laws on securing supply let the government direct production and requisition goods; none suspends the MDR.
Source: Medizinprodukterecht-Durchführungsgesetz (MPDG) §90(3); Basic Law Arts. 80a, 115a; Wirtschaftssicherstellungsgesetz §1; Bundesleistungsgesetz §§1-2
Route today. ANSM may authorize the Minister of Defense to use a device that lacks its MDR certificate, when no suitable device is available and the use meets specific national-defense needs. It covers devices made by the armed forces health service, made to the ministry's order, or imported by it. Widened on August 19, 2026.
Who applies and decides. The Ministry of Defense applies; ANSM authorizes
If war broke out: who buys. The armed forces health service's supply directorate (DAPSA), a central purchasing body that buys and stores health products and equipment for the forces at home and abroad.
If war broke out: who decides. ANSM, on the Defense Ministry's request. In war the state can requisition goods and services, and since August 2026 it can order any company to hold up to 24 months of strategic inputs for defense equipment, including medical support.
Source: Code de la santé publique L.5211-3 IV (IVDs: L.5221-3 IV), as amended by Loi n° 2026-791, Article 24; Code de la défense L.2212-1, L.1339-1 (Loi 2026-791, Art. 10)
Route today. Exemptions for devices placed on the market only within the Army or for its special tasks. Separately, a doctor may use a single non-conforming device in a life-threatening condition, without an application, if no conforming device exists and the patient consents.
Who applies and decides. The Interior Department, in agreement with the Defense Department
If war broke out: who buys. The Army Pharmacy (Armeeapotheke), which supplies the Army's medical materiel in all situations.
If war broke out: who decides. The Interior Department with the Defense Department, for Army-only devices. In active service the Army can require private property; the national supply law treats medical products as vital goods.
Source: Medical Devices Ordinance (SR 812.213), Article 22(2) and (3); Military Act Art. 80; National Economic Supply Act Arts. 31, 34
Route today. Devices without CE marking may be authorized for Spanish military health facilities outside Spain, if they are legally sold in another country and no suitable alternative can be supplied from Spain. Abroad only; a device approved nowhere does not qualify.
Who applies and decides. The Defense Health Inspectorate (Inspección General de Sanidad de la Defensa)
If war broke out: who buys. The Defense Health Inspectorate, as contracting authority, with the Defense military pharmacy center.
If war broke out: who decides. AEMPS inside Spain; the Defense Health Inspectorate for facilities abroad. In conflicts and disasters the government can task Defense with making devices, subject to AEMPS authorization. A state of alarm or siege allows requisition of goods and intervention in factories.
Source: Real Decreto 1155/2020, first additional provision (d); Real Decreto 1155/2020; Ley Orgánica 4/1981 Arts. 11, 32-33
Route today. National Article 59 derogation: the manufacturer applies and the health ministry decides within 60 days; a separate single-patient route. No military provision.
Who applies and decides. The manufacturer applies; the Ministry of Health decides
If war broke out: who buys. No single central buyer: Defense contracting units such as the Directorate of Commissariat and General Services buy medical devices.
If war broke out: who decides. The Ministry of Health, under the ordinary Article 59 route. Parliament declares a state of war and confers powers on the government; the military code allows requisition of materials, instruments and equipment.
Source: D.Lgs. 137/2022, Article 11; Constitution Art. 78; Codice dell'ordinamento militare Arts. 370, 387
Route today. National Article 59 permit. The applicants are healthcare providers and public health bodies, not the manufacturer. No military provision.
Who applies and decides. A healthcare provider or public body applies; the regulator decides
If war broke out: who buys. The Defense Ministry's military health department sets policy; the forces' central medical supplier could not be confirmed on an official page.
If war broke out: who decides. The civilian regulator, on a healthcare provider's application (military hospitals included). Martial law lets the state task and manage suppliers and require goods for the forces, but does not waive device rules.
Source: Medical Devices Act 2022, Article 29; Act on Martial Law Art. 25; Homeland Defence Act Arts. 638, 648
Route today. Humanitarian and exceptional use of a non-UKCA-marked device to protect patients' health. No armed-forces provision in the device regulations.
Who applies and decides. The manufacturer or UK Responsible Person applies; MHRA decides
If war broke out: who buys. Defence Equipment & Support, the Ministry of Defence's procurement agency; Defence Medical Services is the clinical lead.
If war broke out: who decides. The MHRA, through exceptional use. Emergency regulations under the Civil Contingencies Act can requisition property and can disapply or modify an enactment, which in principle reaches the device regulations.
Source: Medical Devices Regulations 2002; Civil Contingencies Act 2004 s.22
Route today. Closed. EU, UK and US sanctions bar or require licenses for supply to the Russian armed forces; the EU's medical exemption covers non-military users only.
Source: Council Regulation (EU) 833/2014; US EAR 746.8 and 744.21
Route today. The Israel Defense Forces' manufacture, marketing, possession and use of medical equipment are governed by army orders, provided they ensure benefit outweighs risk.
Who applies and decides. The IDF
If war broke out: who buys. The Defense Ministry's Defense Procurement Directorate, which buys for every IDF branch.
If war broke out: who decides. The IDF itself, under army orders. In a state of emergency, emergency regulations can change or suspend any law, and ministers can control the production and use of any commodity.
Source: Medical Equipment Law 5772-2012, section 20(b); Basic Law: The Government ss.38-39; Commodities and Services (Control) Law 1957
Route today. SFDA may exclude devices from marketing authorization in "public emergencies such as natural disasters, wars, or epidemics". An import permit is still needed.
Who applies and decides. An importer with a healthcare provider's declaration; SFDA decides
If war broke out: who buys. The Armed Forces Medical Services of the Ministry of Defense; public health purchasing runs through NUPCO, which in 2019 agreed to study taking over the forces' medical supply chain.
If war broke out: who decides. SFDA, under its emergency waiver, which names war.
Source: Implementing Regulation of the Medical Devices Law, 8.3 First (A); SFDA MDS-REQ 5; Implementing Regulation of the Medical Devices Law, 8.3
Route today. Emergency use approval for medical products the state needs in a declared health emergency, epidemic or pandemic. The procedures await an executive regulation.
Who applies and decides. The Emirates Drug Establishment
If war broke out: who buys. Tawazun Council, which runs procurement for the Ministry of Defence and security agencies.
If war broke out: who decides. The Emirates Drug Establishment; the Cabinet can also exempt medical products from marketing authorization. Martial law is the only condition under which the constitution may be suspended.
Source: Federal Decree-Law No. 38 of 2024, Article 11; Federal Decree-Law 38/2024 Art. 5(3)
Route today. Special import of an unregistered device for personal use or a hospital, on the user's signed pledge, never in commercial quantities. Government buying runs through the Unified Procurement Authority.
Who applies and decides. The user or hospital applies; the Egyptian Drug Authority decides
If war broke out: who buys. The Armed Forces Medical Services Department; by law, government hospitals buy medical supplies through the Unified Procurement Authority (whether the military does is not confirmed).
If war broke out: who decides. The Egyptian Drug Authority, through special import. A declared emergency, which can be triggered by war, lets the President requisition property and control the sale of goods.
Source: EDA guideline GL.CAMD.007 (September 2025); Law 151/2019; Law 162/1958 Arts. 1, 3; Law 151/2019 Art. 3
Route today. Device registration has not started ("still in development", per SAHPRA). A licensed medical device establishment can supply now. State international tenders must buy registered devices.
Who applies and decides. A licensed establishment supplies
If war broke out: who buys. Armscor, the defense acquisition agency (whether the Military Health Service's consumables go through it is not confirmed).
If war broke out: who decides. SAHPRA, though device registration is not yet in force. In a state of national defense or emergency, the President can make regulations to deal with it.
Source: SAHPRA medical devices page; Medical Device Regulations 2016, regulation 2(2); Defence Act 2002 ss.89-91; State of Emergency Act 1997 s.2
Route today. Emergency use authorization covers devices including IVDs, primarily in declared public health emergencies; the emergencies described include "any incident with a significant potential to affect national security".
Who applies and decides. The applicant files with NAFDAC
If war broke out: who buys. The Nigerian Army Medical Corps, buying through the Ministry of Defence's Department of Procurement.
If war broke out: who decides. NAFDAC, through an emergency use authorization once an emergency is declared.
Source: NAFDAC Guidelines for Emergency Use Authorization for Medical Products (effective July 25, 2025); Constitution s.305
Route today. The Pharmacy and Poisons Board may authorize import of a specified quantity of an unregistered health product, for a specified period, to a specified person or institution.
Who applies and decides. The importer applies; the Pharmacy and Poisons Board decides
If war broke out: who buys. The Kenya Defence Forces' Directorate of Medical Services; the Ministry of Defence tenders for medical equipment itself.
If war broke out: who decides. The Pharmacy and Poisons Board. When Kenya is at war, public-security regulations may suspend other laws and requisition property.
Source: Legal Notice 100 of 2022, rule 16; Preservation of Public Security Act ss.3(4), 4(2)(g)
Route today. A permit to import or use an unregistered medicine or medical device "in compelling circumstances".
Who applies and decides. The Ethiopian Food and Drug Authority decides
If war broke out: who buys. We could not confirm the defense health department or its buyer on an official page.
If war broke out: who decides. The Ethiopian Food and Drug Authority. A state of emergency gives the Council of Ministers broad power by regulation.
Source: Proclamation 1112/2019, Article 20(5); Constitution Art. 93
Route today. In a public health emergency or in the public interest, the regulator may deviate from registration procedures. The new Act's start date has not been confirmed.
Who applies and decides. The Botswana Medicines Regulatory Authority
If war broke out: who buys. We could not confirm the Botswana Defence Force's medical buyer on an official page.
If war broke out: who decides. The Botswana Medicines Regulatory Authority. A proclaimed public emergency lets regulations take possession of property and suspend laws.
Source: Medicines and Related Substances Act 29 of 2025, section 38; Emergency Powers Act (Cap. 22:04) ss.3-4
Route today. Since September 8, 2026, devices made, imported or supplied for the Defence Department are exempt from ARTG inclusion, if a Defence clinical governance committee approves each device before use and Defence keeps custody and records.
Who applies and decides. Defence (a Defence medical practitioner directs use)
If war broke out: who buys. The Department of Defence; we could not confirm the name of its current medical buying office on an official page.
If war broke out: who decides. Defence itself, under item 2.20. For civilians, the Health Minister can exempt devices, a power a national emergency declaration also opens. Any goods needed for military purposes can be required under the Defence Act.
Source: Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 4 Part 2, item 2.20; Therapeutic Goods Act s.41GS; National Emergency Declaration Act 2020 s.11; Defence Act 1903 s.67
Route today. Devices need only a database notification within 30 working days of arrival; there is no premarket approval for most devices.
Who applies and decides. The importer notifies
If war broke out: who buys. Defence Health, the New Zealand Defence Force's health agency, which buys clinical products itself.
If war broke out: who decides. No premarket approval to bypass; the sponsor notifies after import. Emergency controllers can provide for the supply of essential goods.
Source: Medicines Act 1981 and the WAND notification requirements; Emergency Management Act 2026
Route today. In an armed attack, the health ministry can grant special import approval for devices needed to treat evacuees, without the usual cabinet-order step. No Self-Defense Forces exemption from device approval.
Who applies and decides. The importer applies; the Ministry of Health, Labour and Welfare approves
If war broke out: who buys. The Acquisition, Technology & Logistics Agency and the Self-Defense Forces' supply depots, which procure medical materiel.
If war broke out: who decides. The Ministry of Health, Labour and Welfare keeps device approval. In an armed attack, governors can buy or expropriate supplies for civilian relief, and the Civil Protection Act's goods list names medical devices.
Source: Civil Protection Act (Act No. 112 of 2004), Article 92; SDF Act Arts. 26, 103; Civil Protection Act Arts. 81, 92
Route today. MFDS can supply urgently needed devices, including any the head of a central government agency requests, imported without a license by a state body. From December 10, 2026, each device is designated first and the Korea National Institute of Medical Device Safety Information imports it.
Who applies and decides. A ministry requests; MFDS designates
If war broke out: who buys. The Armed Forces Medical Command; the Defense Acquisition Program Administration is the legal buyer, and medical items it buys through the Public Procurement Service go to that service.
If war broke out: who decides. MFDS. The Defense Minister can ask it to designate an emergency import. In war, the Requisition Act lets the Defense Minister (or a martial-law commander) requisition medical devices, which it names.
Source: Medical Devices Act, Article 15-2; Requisition Act Art. 5; Martial Law Act Arts. 7, 9; Defense Acquisition Program Act Art. 25
Route today. Special case-by-case approval to make or import a specific device, including to respond to a public health emergency.
Who applies and decides. The central health authority approves
If war broke out: who buys. The Defense Ministry's Medical Affairs Bureau, whose pharmaceutical division plans peacetime and wartime medical supply; the ministry's procurement office runs the joint medical-materiel tenders.
If war broke out: who decides. The Ministry of Health and Welfare, through special approval. A presidential emergency decree opens mobilization, and the Defense Ministry can then requisition supplies.
Source: Medical Devices Act, Article 35; Constitution Additional Articles Art. 2(3); All-out Defense Mobilization Readiness Act; Martial Law Act Art. 11
Route today. Military use of devices is supervised under the national regulations and military rules: oversight, not an exemption. Military medical research bodies are on the US Entity List.
If war broke out: who buys. The Central Military Commission's Logistic Support Department (names only; we do not cover supply to the PLA).
If war broke out: who decides. The revised National Defense Mobilization Law (in force October 1, 2026) calls up drugs, equipment and facilities for wartime medical care.
Source: Regulations on the Supervision and Administration of Medical Devices (State Council Order 739), Article 106; National Defense Mobilization Law (revised 2026) Art. 54
Route today. No device law yet; listing is voluntary. A bill to create a statutory regime is planned.
If war broke out: who buys. No local armed forces; defense is a central government matter.
If war broke out: who decides. No device approval exists to bypass. In an emergency, the Chief Executive in Council may make any regulations, including on imports and taking property.
Source: Medical Device Administrative Control System (voluntary); Emergency Regulations Ordinance (Cap. 241)
Route today. An emergency device made, imported or supplied for or on behalf of the Government is exempt from licensing and registration, once the Minister designates it for a civil defence emergency or a serious infectious disease. Separately, a doctor may obtain an unregistered device for a patient.
Who applies and decides. The Minister designates, on HSA's opinion
If war broke out: who buys. The Defence Science and Technology Agency, MINDEF's acquisition agency; HQ Medical Corps leads the SAF's medical service.
If war broke out: who decides. The Minister, on HSA's opinion, under regulation 13C, which needs a declared civil defence emergency. The Civil Defence Act's definition covers events whether or not they are caused by an enemy attack or a warlike act. The government can also requisition any goods.
Source: Health Products (Medical Devices) Regulations 2010, regulations 8 and 13C; Civil Defence Act 1986 s.102; Requisition of Resources Act s.12
Route today. Special access exemption from registration, by notification to the Medical Device Authority (RM 300; up to 14 working days). No armed-forces category.
Who applies and decides. A local importer or manufacturer notifies MDA
If war broke out: who buys. The Ministry of Defence's Procurement Division.
If war broke out: who decides. The Medical Device Authority, under the special access exemption. In a declared security area, the National Security Council can take temporary possession of movable property.
Source: Medical Device (Exemption) Order 2024, P.U.(A) 78/2024 (replacing the 2016 Order); National Security Council Act 2016 s.30
Route today. State agencies, and the Thai Red Cross, may make, import or sell devices without registration when preventing, diagnosing or treating disease. A separate permit covers import in an emergency or disaster.
Who applies and decides. The state agency files a statement of purpose with Thai FDA
If war broke out: who buys. Each service's medical department appears to buy for itself; we could not confirm a central military medical buyer.
If war broke out: who decides. No decision needed for state agencies, which may import unregistered devices under section 27(1). Under martial law, the military may requisition tools and equipment of all kinds, and martial law prevails over laws at variance with it.
Source: Medical Devices Act B.E. 2551 (2008), section 27(1) and (8); Martial Law Act B.E. 2457, sections 2 and 10
Route today. Emergency use authorization in an emergency, disaster, outbreak or health crisis; and a special-route import without a marketing authorization, with the minister's approval.
Who applies and decides. The Minister of Health or the food and drug authority decides
If war broke out: who buys. The Defense Ministry's Defense Equipment Center buys defense equipment; we could not confirm on an official page who buys the armed forces' medical materiel.
If war broke out: who decides. The Minister of Health, through emergency use authorization or special-route import. In a declared state of war, the 1959 state-of-danger law allows taking goods of any kind and overriding other laws; that law is before the Constitutional Court in 2026.
Source: Permenkes 5/2026, Articles 50(3) and 62; Perppu 23/1959, Pasal 37 and 44
Route today. Compassionate special permit for an unregistered device, decided in seven working days; the device must already be registered by its origin or another regulator.
Who applies and decides. The FDA decides
If war broke out: who buys. We could not confirm the armed forces' medical buyer on an official page. Emergency negotiated procurement is allowed under the 2024 procurement law.
If war broke out: who decides. The FDA. Martial law does not suspend the constitution, and emergency powers need an act of Congress. In 2020 a pandemic law let donated products certified by established regulators in and freed device purchases from procurement rules, a precedent but not standing law.
Source: FDA Administrative Order 2025-0024; Constitution Art. VI s.23(2), Art. VII s.18; RA 12009 s.35; RA 11469 (precedent)
Route today. The health ministry may waive all or part of the clinical trial for devices urgently needed for national defense and security, epidemics or disasters. Registration is still required.
Who applies and decides. The Ministry of Health decides
If war broke out: who buys. We could not confirm the Military Medical Department's buying role on an official page.
If war broke out: who decides. The Ministry of Health. Under martial law, the commander can compulsorily purchase or requisition property. A new Law on State of Emergency, in force July 1, 2026, lets the Prime Minister apply measures the law does not provide for.
Source: Decree 98/2021, Article 13(3), as amended by Decree 96/2023; Law on National Defense 2018 Art. 21; Law on State of Emergency 104/2025 Art. 12
Route today. An import license for clinical investigation, test, evaluation, demonstration or training. No defense provision in the device rules.
Who applies and decides. The importer applies; the Central Licensing Authority decides
If war broke out: who buys. The Directorate General Armed Forces Medical Services procures, stocks and issues military medical equipment through its medical store depots (per a 2012 national audit report).
If war broke out: who decides. The Central Licensing Authority. A proclaimed national emergency lets Parliament legislate on any matter, but no wartime law of that kind is in force today.
Source: Medical Devices Rules 2017, rule 40; Constitution Arts. 352-353
We read each change at the authority's own document and keep the result, dated, on one page across our markets.
See the regulatory changes tracker →Of the 41 markets on this page, seven have a written route that names the military: the United States, Germany, France, Switzerland, Spain (for its facilities abroad), Israel and Australia. Ukraine has one too. Brazil, Mexico and Vietnam name the military inside broader routes.
Not under any military route we read. The armed forces, a defense ministry or another government body starts it, and the manufacturer supplies the evidence. Under the general emergency routes, the applicant is usually a hospital, an importer or a doctor.
Usually two things: the government gains emergency powers to requisition supplies or set rules aside, and the armed forces become a much larger buyer. Ukraine waived its device conformity rules for a time in February 2022 and later withdrew the waiver. The last column on this page lists who buys for the armed forces and who would decide on an unapproved device.
No. Every route here bridges a gap: one patient, one emergency, one military need. Most bar resale, and none replaces registration. Keep the civilian file moving.
For the story behind the military routes, with a worked example for a trauma device, read Military use of unapproved medical devices: which countries allow it, and who holds the key.
We read each market's device law, regulations and, where they exist, defense and emergency-powers laws, at the authority's own text or its official gazette, as of November 2, 2026. Where a law does not name the armed forces, saying a military hospital could use a route is our reading. Where we could not confirm that an instrument is still in force, the card says so. This page is a summary for planning, not legal or regulatory advice; check the current instrument before acting.
Most companies come to us with one of these four questions. Each one is a conversation, not a form.