Top 10 Countries for Medical Device Exports

Medical devices are a major global trade category – from syringes and surgical instruments to imaging machines and implantable devices. Knowing which countries export the most and what each country’s regulatory rules require is essential if you manufacture, source, or plan to export devices. This article lists the Top 10 Countries for Medical Device Exports (by export value in 2023) and explains the key licensing and market-entry requirements for each. The goal is simple: give an exporter or manufacturer a clear, practical view of what paperwork, labelling, certification, and local representation each market expects.

1. United States – (Top exporter)

The U.S. is the world’s largest exporter of medical instruments and devices by value. 

Regulator / main rule: U.S. Food & Drug Administration (FDA). Medical devices are regulated based on risk (Class I–III). Devices intended for the U.S. market must meet applicable FDA requirements (quality system, labelling, registration) unless exported under specific export provisions. 

U.S. Food and Drug Administration

Practical steps to export from/to the U.S.:

• Determine device classification (Class I/II/III) under FDA rules.
• If marketing in the U.S., register the establishment and list devices (unless exempt), follow 21 CFR QMS (for many devices).
• If exporting from the U.S., the FDA issues export certificates (e.g., Certificate to Foreign Government, Certificate of Exportability, Free Sale Certificate). These help foreign buyers and regulators. Read the FDA Exporting Medical Devices guidance and request the correct certificate.

2. Germany – (Large European exporter/manufacturing hub)

Germany is a major EU manufacturing and export hub for medical devices. 

Regulator / main rule: For EU market access, devices must comply with the EU MDR (Medical Device Regulation 2017/745) and carry a CE mark (issued via conformity assessment by a Notified Body for many devices). National German authorities support enforcement and market surveillance. 

Practical steps:

• Ensure conformity with EU MDR: technical documentation, clinical evidence, risk management, UDI (where applicable).
• For devices requiring third-party assessment, work with a Notified Body and prepare a Declaration of Conformity and CE mark.
• If located outside EU and exporting to EU buyers (or from Germany elsewhere), understand whether CE marking or additional export certificates are needed.

3. Mexico – (Major exporter & manufacturing location)

Why on list: Mexico has large medical-device manufacturing and export activity (medical clusters, maquiladoras). 

Regulator / main rule: COFEPRIS (Federal Commission for Protection against Sanitary Risks) is Mexico’s regulator. Devices are classified by risk and require registration or notification; labeling often must be in Spanish and follow NOM standards. A Mexican registration holder or local representative is typically required.

Practical steps:

• Classify device under Mexican rules and prepare dossier (risk-based).
• Translate labeling and IFU into Spanish; follow NOM standards (e.g., NOM-137).
• Appoint a Mexican Registration Holder or local representative if you don’t have a Mexican entity. Then submit to COFEPRIS for approval or registration.

4. Netherlands – (Large exporter; major logistics & medtech manufacturing)

The Netherlands is a big exporter due to its manufacturing and its role as an EU logistics hub. 

Regulator / main rule: As an EU country, the Netherlands follows EU MDR and CE-mark rules. Exporters supplying outside the EU may also need Free Sale Certificates or other export documentation from national authorities. 

Practical steps:

• Follow EU MDR conformity pathways; use a Notified Body if required.
• For exports outside the EU, obtain national export documentation or Free Sale Certificate as needed.

5. China – (Growing exporter & large internal market)

Why on list: China is a fast-growing exporter and large domestic manufacturing base for devices. 

Regulator / main rule: NMPA (National Medical Products Administration) oversees medical devices. Imports typically require registration with NMPA, a local responsible party (local agent), product classification (Class I/II/III), and compliance with Chinese standards and requirements. Recent law updates (2024 onward) strengthened NMPA processes. 

Practical steps:

• Classify the device under China’s risk classes and compile the required technical dossier.
• Appoint a local agent in China to handle registration and post-market duties.
• Prepare to meet local standards and possibly perform local testing or clinical evaluation per NMPA guidance.

6. Costa Rica – (Large contract-manufacturing/exporter hub)

Costa Rica hosts several large contract manufacturers and exporters in the medical device industry (notably for disposables, components). 

Regulator / main rule: The Ministry of Health (Ministerio de Salud) is responsible for device registration; classification and registration requirements are risk-based. Often, an in-country representative (importer or authorised rep) is required, and registration certificates typically last several years. 

Practical steps:

• Classify the device according to Costa Rican rules and submit a two-phase registration (pre-check, then technical dossier).
• Appoint a local authorised representative or importer.
• Expect translation of documents and a registration validity (commonly 5 years in practice) if approved.

7. Ireland – (Major exporter – medtech cluster & contract manufacturing)

Ireland remains a key medtech exporter, driven by multinational manufacturing and exports (many medtech companies have plants there). 

Regulator / main rule: As an EU territory, access follows EU MDR and CE-marking rules; foreign manufacturers exporting to the EU need an EU Authorised Representative. Ireland is also a big manufacturing base for multinational firms. 

Practical steps:

• Obtain CE marking under EU MDR; appoint an EU Authorised Representative if you’re outside the EU.
• Prepare technical documentation and quality system evidence; for many devices, a Notified Body assessment is required.

8. Belgium – (High-value manufacturing and exports)

Belgium exports a large value of medical instruments due to specialised manufacturers and logistics. 

Regulator / main rule: Belgium follows the EU MDR for market access/CE marking. For exports outside the EU, sellers may obtain national Free Sale or export certificates. 

Practical steps: Same EU MDR steps: classification, conformity assessment, Notified Body where required, UDI and technical documentation, and national export documentation if shipping outside the EU.

9. Switzerland – (High-value devices & precision instruments)

Switzerland is known for precision instruments and high-value medical device exports. 

Regulator/main rule: Swissmedic oversees medical devices. Historically, Switzerland has aligned closely with EU rules, but Swissmedic also issues its own guidance and Free Sale Certificates for exports. Switzerland is introducing Swissmedic UDI/registration systems (with phased deadlines). 

Practical steps:

• Follow Swissmedic guidance – many devices follow EU conformity assessment approaches, but check Swissmedic rules and registration/UDI obligations.
• Swissmedic can issue export (Free Sale) certificates on request for devices marketed in Switzerland.

10. United Kingdom – (Significant exports; changed rules post-Brexit)

The UK remains a top exporter with strong medtech manufacturing and R&D. 

Regulator / main rule: MHRA (Medicines and Healthcare products Regulatory Agency) now uses UK rules; devices for Great Britain (England/Wales/Scotland) typically require UKCA conformity or other MHRA registration details. Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) for registration. Northern Ireland rules may differ due to EU alignment. 

Practical steps:

• Determine whether your device is sold in Great Britain or Northern Ireland (different rules).
• Appoint a UK Responsible Person (UKRP) if you don’t have a UK entity. Register devices with MHRA before placing them on the GB market. Obtain UKCA marking or follow transitional arrangements where relevant.

Common documentary & compliance themes across these top exporters

While country specifics differ, most top export markets share these core requirements:

1. Risk-based classification – devices are classified (low to high risk), and classification determines the level of dossier and third-party assessment. 
2. Quality Management System (QMS) – many markets expect a QMS (ISO 13485 often accepted or required).
3. Technical Documentation / Clinical Evidence – manufacturers must prepare technical files proving safety and performance.
4. Authorised Local Representative – non-resident manufacturers usually must appoint a local rep (EU Authorised Representative, UKRP, China local agent, Mexican registration holder, etc.)
5. Labelling & Language – local language labelling (e.g., Spanish in Mexico) and country-specific labelling rules are common.
6. Export / Free Sale Certificates – many countries issue Free Sale / Export Certificates (FDA, Swissmedic, national authorities) that help with cross-border trade.

Practical checklist for manufacturers who want to export internationally

1. Decide target markets and check whether the market is within the EU/UK/China/US or requires local registration.
2. Classify your device under each target market’s rules.
3. Prepare technical documentation (design, risk, clinical evidence, labelling).
4. Implement or verify QMS (ISO 13485 is widely accepted).
5. Appoint local reps when needed (EU AR, UKRP, China local agent, Mexico registration holder).
6. Get required conformity assessments (Notified Body for many EU devices; PMDA/PMDA-type review in Japan for high-risk; NMPA in China).
7. Request export / free-sale certificates from your national regulator when the buyer or importing country asks.