Selling medical devices to public health systems.

The two layers

Every market has two gates for device suppliers:

1. Regulatory approval, usually through a local representative. No hospital can buy an unapproved device.
2. Procurement rules: who buys (central purchasing bodies, group purchasing organisations or individual hospitals), and any origin rules or national preferences.

European Union

Approval:

• CE marking under the Medical Devices Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR). Class IIa and above need a notified body; class I is self-declared (except sterile, measuring and reusable instruments).
• Non-EU manufacturers must appoint an EU authorised representative (Art. 11).
• Transition for legacy devices (Regulation 2023/607), if you had a quality system and a notified-body application in place by 26 May 2024 and a signed agreement by 26 September 2024:
  • class III and class IIb implantables: until 31 December 2027;
  • other classes: until 31 December 2028.
• IVDs (Regulation 2024/1860): class D until 31 December 2027, class C until 31 December 2028, class B and sterile class A until 31 December 2029.
• EUDAMED: four modules became mandatory on 28 May 2026: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.

Procurement:

• Above-threshold tenders follow Directive 2014/24 and appear on TED. See how to bid for EU tenders on TED.
• Buyers include national and regional central purchasing bodies and hospital groups (in France, for example, UGAP, Resah and UniHA; in Italy, Consip and the regional aggregators), plus hospitals tendering on their own.

Origin rules: since 30 June 2025, under the International Procurement Instrument, Chinese operators are excluded from device tenders of €5 million or more, and winners must keep Chinese-origin content to 50% or less.

Coming: the Commission proposed a targeted MDR/IVDR revision on 16 December 2025, covering classification, clinical evidence, notified-body involvement and digital devices. It’s still before Parliament and Council.

United Kingdom

Approval:

• Great Britain accepts UKCA marks and, for now, CE marks:
  • devices under the old EU directives (MDD, AIMDD): until 30 June 2028, or earlier certificate expiry;
  • IVDD devices and devices under the EU MDR or IVDR: until 30 June 2030.
• Every device must be registered with the MHRA (£240 per application). Non-UK manufacturers need a UK Responsible Person.
• Northern Ireland follows EU rules.
• Pending: the MHRA consulted from February to April 2026 on recognising EU CE marks indefinitely, and on a reliance route for some devices. It wasn’t law as of June 2026.

Procurement:

• NHS Supply Chain runs national frameworks. Regional hubs (such as the NHS London Procurement Partnership) and individual trusts also tender.
• Tenders follow the Procurement Act 2023 and appear on Find a Tender. See how to bid for UK government contracts.
• Digital health tools need the DTAC assessment. A shorter form became mandatory by 6 April 2026.
• The government launched value-based procurement guidance for medtech in October 2025, piloted with 13 trusts and rolled out through NHS Supply Chain during 2026.

Indian suppliers: NHS purchases of goods are covered by the UK–India trade agreement, but health services and medical staffing aren’t. See Indian companies bidding for UK government contracts.

United States

Approval:

• FDA 510(k), De Novo or PMA, plus establishment registration and device listing.
• Since 2 February 2026, FDA’s Quality Management System Regulation incorporates ISO 13485:2016 by reference.

Procurement:

• The VA Federal Supply Schedule 65 II A covers medical equipment and supplies.
• The Defense Logistics Agency buys through its own electronic catalogue and prime vendor programmes.
• Notices appear on SAM.gov. See how to register in SAM.gov.

Origin rules:

• The Trade Agreements Act applies to FSS contracts: products must come from the US or a designated country. The EU, UK, Japan, Korea, Canada and Australia are designated; India and China aren’t.
• A Section 232 investigation into medical consumables and devices opened in September 2025. No device tariffs had been imposed as of September 2026.

Canada

Approval:

• Class II–IV devices need a Health Canada Medical Device Licence, which requires an MDSAP certificate.
• Class I devices are sold through an importer or distributor holding an establishment licence.

Procurement: hospital buying is provincial. Shared-services bodies and group purchasing organisations such as HealthPRO and Mohawk Medbuy run most tenders.

Origin rules:

• The federal Buy Canadian Policy has applied since 16 December 2025.
• The interim reciprocal procurement policy (14 July 2025) generally excludes suppliers from countries without a trade agreement with Canada from federal procurement.
• Both are federal, with little direct effect on provincial hospital buying, though some provinces are reviewing US contracts.

Australia

Approval:

• Devices must be included in the ARTG by an Australian sponsor.
• Approvals from comparable regulators (EU, US, Canada, Japan, Singapore, and the UK since December 2025) can support the application.

Procurement:

• HealthShare NSW buys for New South Wales.
• HealthShare Victoria (formerly HealthPurchasing Victoria) runs collective agreements that Victorian public health services must use unless exempt.
• Other states tender through their own portals. See how to bid for government contracts in Australia.

Origin rules: no device origin ban. State industry-participation policies can apply.

Japan

Approval:

• Under the PMD Act:
  • class III–IV and novel devices need MHLW approval after PMDA review;
  • designated class II and III devices are certified by registered certification bodies;
  • class I devices are notified.
• Foreign manufacturers need a Japan-based Marketing Authorisation Holder and foreign manufacturer registration (valid five years).

Procurement:

• Mainly the National Hospital Organization and national university hospitals, under the WTO GPA.
• Comprehensive evaluation (price plus quality) is mandatory for medical technology above SDR 385,000 (¥77 million).
• See how to bid for government contracts in Japan.

Korea

Approval: MFDS notification (class I), certification (class II) or approval (class III–IV), plus Korean GMP. The Digital Medical Products Act, in force since 24 January 2025, covers digital devices and drug–digital combinations.

Procurement: the Public Procurement Service runs tenders on KONEPS, where national and university hospitals also tender. Comprehensive evaluation applies to medical technology above SDR 385,000. See how to bid for government contracts in South Korea.

Brazil

Approval:

• ANVISA: classes I–II are notified and classes III–IV registered (RDC 751/2022; IVDs under RDC 830/2023).
• A Brazil Registration Holder is required, and classes III–IV need Brazilian GMP certification.
• Reliance route (since June 2024): class III–IV devices already approved by the FDA, Health Canada, the TGA or Japan’s MHLW can use a faster review, though a full dossier is still needed.

Procurement: SUS purchasing is split across the federal Ministry of Health, states and municipalities, under Law 14.133/2021. Notices appear on PNCP and Compras.gov.br. See how to bid for public contracts in Brazil.

Preferences: national products can get a preference margin of up to 10%, rising to 20% for products of national technological development (Law 14.133, Art. 26).

New in 2026: Law 15.210/2025 added Art. 44-A to the procurement law, in effect from about March 2026. For SUS diagnostic or therapeutic equipment above R$50,000 (or with running costs above R$50,000 a year):

• tenders must consider proper use over the equipment’s life;
• the notice must show the buyer can operate it, or has a plan to.

EU suppliers: the EU–Mercosur agreement excludes SUS-related procurement, so device sales to SUS get no treaty protection.

India

Approval:

• CDSCO licensing under the Medical Devices Rules 2017, now mandatory for all classes.
• Imports need an import licence (Form MD-15), applied for by an Indian authorised agent.

Procurement: central buyers must use GeM for items listed on it. State medical services corporations and AIIMS run their own e-tenders. See how to register on GeM.

Origin rules:

• The Make in India order applies, with the Department of Pharmaceuticals as the nodal ministry for devices.
• Supplier classes:
  • Class-I local supplier: at least 50% local content;
  • Class-II: 20–50%;
  • non-local: below 20%, excluded from most tenders.
• Global tenders are barred below ₹200 crore unless the device is on the Department of Pharmaceuticals’ exemption list (354 devices). The list was reopened for review in February 2026.

United Arab Emirates

Approval:

• Federal device regulation moved from the Ministry of Health and Prevention to the Emirates Drug Establishment on 29 December 2025. Existing certificates stay valid until they expire.
• Registration goes through a UAE-licensed local agent.

Procurement:

• The federal procurement law excludes medicines and medical supplies, and the India–UAE CEPA excludes medicines.
• Abu Dhabi: Rafed, the PureHealth group purchasing organisation, became the designated distributor for the Department of Health’s Unified Procurement Program in 2025.
• Dubai: the Dubai Health Authority tenders through Dubai eSupply.
• Northern emirates: Emirates Health Services.
• See In-Country Value certificates.

Saudi Arabia

Approval: an SFDA Medical Device Marketing Authorization (MDMA) through the GHAD system. Foreign manufacturers need a Saudi-resident authorised representative. CE or FDA approval supports the file but doesn’t replace it.

Procurement: NUPCO buys centrally for the Ministry of Health and other government health providers, under the Government Tenders and Procurement Law, with e-tendering on Etimad.

Origin rules:

• National products get a 10% price preference: foreign bids are evaluated as 10% higher.
• Items on the local content authority’s mandatory list must be national. A March 2025 update added 116 items, including 103 medical supplies.

China

Approval: NMPA registration for imported class II–III devices and filing for class I, through a China-based legal agent.

Procurement: high-value consumables are bought through volume-based procurement run by national and provincial alliances, which has driven deep price cuts.

Origin rules:

• Since 6 July 2025, EU companies are excluded from government device purchases with budgets above RMB 45 million, in retaliation for the EU measure. EU-invested manufacturers producing in China are exempt.
• Since 1 January 2026, qualifying domestic products get a 20% price-evaluation discount in government procurement.

Practical advice

• Approval first, tenders second. Start the regulatory process early; it’s the longest step everywhere.
• Choose your local representative carefully. In Japan and Brazil the local holder owns the registration, so changing partner later can mean re-registering. Where you can, use an independent representative or your own subsidiary.
• Map origin rules to your supply chain. EU, US and Chinese rules now depend on where components are made, not just where the company is based.
• Target central buyers. NUPCO, NHS Supply Chain, HealthShare, Rafed and the US VA schedules each open a whole system with one contract.
• Consider partnering in protected markets. In India and Brazil, local manufacturing or a joint venture can turn a non-local bid into a preferred one. See consortium and joint venture bidding rules.

What changed in 2025–2026

• EU: EUDAMED’s first four modules became mandatory (28 May 2026); a targeted MDR/IVDR revision was proposed (16 December 2025).
• EU and China: the EU excluded Chinese bidders from device tenders ≥ €5m (30 June 2025); China excluded EU firms above RMB 45m (6 July 2025) and introduced a 20% domestic preference (1 January 2026).
• UK: consultation on indefinite CE recognition (February–April 2026); DTAC refresh (by April 2026); NHS value-based procurement (from October 2025).
• US: QMSR in force (2 February 2026); a Section 232 investigation into devices, with no tariffs as of September 2026.
• Canada: Buy Canadian Policy (16 December 2025) and the reciprocal procurement policy.
• Brazil: the new equipment rule for SUS (Law 15.210/2025).
• UAE: device regulation moved to the Emirates Drug Establishment (29 December 2025).
• Saudi Arabia: medical supplies added to the mandatory local list (March 2025).
• India: the global tender exemption list reopened for review (February 2026).
• Korea: Digital Medical Products Act (24 January 2025).
• Australia: the UK became a comparable overseas regulator (December 2025).

Questions

Sources

• MHRA: regulating medical devices in the UK
• MHRA: medical devices, EU regulations for MDR and IVDR
• FDA: Quality Management System Regulation
• US FAR 52.225-5: Trade Agreements
• India Department of Pharmaceuticals: medical devices
• Victorian Auditor-General: HealthShare Victoria collective purchasing (2025)

This guide explains the rules in plain English; it isn’t legal advice. Procurement rules change, and each tender document sets its own conditions — it always prevails.