For women's health founders moving from Latin America into the EU. Choose where you come from, where you are going and what you sell, and the guide answers the five questions that corridor raises: can you sell there, do you need a company, can your health data cross, can you move and hire, and what do you gain.
This guide helps you ask the right questions; it does not answer them for your company. Laws change, and every entry links to its source so you can check it. Where an entry is our own reading rather than a rule, it says so. Before you incorporate or move any health data, confirm with a lawyer and a tax adviser in both countries, or book a call with us to work through your case.
Search the EUIPO database before you spend anything else. An EU trade mark filed online costs €850 for one class, €50 for the second and €150 for each further class.
Source: EUIPOChecked 9 October 2026Medical devices need a clinical evaluation based on sufficient clinical data for their intended purpose (MDR art. 61 and Annex XIV). In vitro diagnostics, such as fertility, hormone or infection tests, need a performance evaluation instead: scientific validity, analytical and clinical performance (IVDR art. 56 and Annex XIII). Whether studies run in Latin America are enough depends on how comparable the population and care setting are. Ask your notified body early.
Source: EUR-LexChecked 9 October 2026The MDR bans misleading claims in labelling, instructions and advertising (art. 7). National rules add more: in Spain, health advertising is controlled by the authorities under the Ley General de Sanidad, and a royal decree on advertising medical devices went to consultation in 2023.
Source: Ministerio de SanidadChecked 9 October 2026Closing a company takes time and money, and in some countries far more than opening it. Each destination in this guide shows its closing route.
Our readingChecked 9 October 2026What depends only on the destination. Pick a destination above to add what depends on where you come from.
| The EU destinations | Spain | Portugal | Luxembourg |
|---|---|---|---|
| 1 · Selling there | |||
| Product regulation | AEMPS. Under Real Decreto 192/2023 (art. 7), manufacturing, importing, assembling or sterilising medical devices in Spain needs a prior operating licence (licencia previa de funcionamiento). Distributors notify the health authority of their autonomous community. Source: AEMPSChecked 8 October 2026 | INFARMED. Decreto-Lei 29/2024 applies the MDR in Portugal and keeps national registration and notification duties for manufacturers, authorised representatives and distributors until EUDAMED is fully running. Source: INFARMEDChecked 8 October 2026 | Direction de la santé. Class I devices and IVDs are registered by email before market placement. Patient information must be in French, German or Luxembourgish; English is accepted for professional-use-only devices. Source: Guichet.luChecked 8 October 2026 |
| Who pays | Since Real Decreto 415/2026, health technology assessment is organised nationally. RedETS evaluates non-drug technologies, including digital ones when the governance council agrees, and its reports inform funding decisions without binding them. Source: BOEChecked 9 October 2026 | INFARMED runs SiNATS, which evaluates health technologies for SNS funding and handles state reimbursement (comparticipação) of some medical device categories. Decreto-Lei 118/2026 (17 June 2026) creates a new SiNATS; current rules stay in force during the transition. Source: INFARMEDChecked 9 October 2026 | The CNS reimburses medical devices that appear on its lists, generally on prescription. Source: CNSChecked 9 October 2026 |
| 2 · The company | |||
| Legal forms and capital | SL (sociedad limitada) from €1 of capital since Ley 18/2022. While capital is under €3,000, 20% of profit goes to the legal reserve and partners are jointly liable for the gap up to €3,000 on liquidation. SA for larger structures. Source: BOEChecked 8 October 2026 | Sociedade por quotas (Lda): minimum €1 per quota. Sociedade anónima: minimum capital €50,000. Regulated activities can require more. Source: Justiça.gov.ptChecked 8 October 2026 | SARL: minimum €12,000, fully paid up at incorporation, before a notary. A simplified SARL-S exists for individuals with lower capital. SA for larger structures. Source: Guichet.luChecked 8 October 2026 |
| Incorporation | Online incorporation through CIRCE is available. Foreign directors and partners need an NIE, a foreign parent company needs a Spanish NIF, and foreign investment is declared to the Registro de Inversiones. Real cost and time not verified this round. Source: PAE / CIRCEChecked 8 October 2026 | Empresa Online: €220 with pre-approved articles, €360 with your own articles (double for urgent). Empresa na Hora at a counter. Non-resident partners need a Portuguese NIF, usually through a tax representative. Source: Justiça.gov.ptChecked 8 October 2026 | Notarial deed, RCS registration and, for most commercial activity, a business permit from the Ministry of the Economy, which looks at the manager's good repute and qualifications. Real cost and time not verified this round. Source: Guichet.luChecked 8 October 2026 |
| Closing the company | An SL is wound up by shareholder resolution, notarial deed and registration with the Registro Mercantil under the Ley de Sociedades de Capital. Official cost not confirmed. Source: BOEChecked 9 October 2026 | Online closure for an Lda or SA: immediate extinction, or dissolution with closure of liquidation, €255 online (€300 in person), filed within two months of the shareholders' resolution. Source: Justiça.gov.ptChecked 9 October 2026 | Dissolution is decided at an extraordinary general meeting before a notary, a liquidator is appointed, and the liquidation closes after an auditor's report: in practice at least three meetings. A company with a single shareholder can be dissolved without liquidation. Source: Guichet.luChecked 9 October 2026 |
| 3 · Health data | |||
| Data protection regulator | AEPD (Agencia Española de Protección de Datos). Source: AEPDChecked 8 October 2026 | CNPD (Comissão Nacional de Proteção de Dados). Source: CNPDChecked 8 October 2026 | CNPD (Commission nationale pour la protection des données). Source: CNPD LuxembourgChecked 8 October 2026 |
| 4 · Moving and hiring | |||
| Founder visa | Entrepreneur residence authorisation (arts. 68 to 70, Ley 14/2013) with a favourable ENISA report on the business plan. No minimum investment or job creation. A telework (digital nomad) route also exists. Source: Ministerio de InclusiónChecked 8 October 2026 | StartUP Visa (IAPMEI): residence for founders whose project is hosted by a certified incubator. Lei 61/2025 changed several residence routes in October 2025, so check current conditions before applying. Source: IAPMEIChecked 8 October 2026 | Self-employed permit: apply from abroad for a temporary authorisation (valid 90 days), with the Ministry of the Economy's consent where a business permit is needed; permit up to 3 years. Investor permit: €500,000 in a new Luxembourg company creating 5 jobs within 3 years, among other options. Source: Guichet.luChecked 8 October 2026 |
| Staff visas | Highly qualified professional authorisation and EU Blue Card, processed by the UGE. Source: Ministerio de InclusiónChecked 8 October 2026 | Highly qualified activity permits, EU Blue Card and the Tech Visa. Lei 61/2025 added a job-seeking visa for specialised technical profiles, to be defined by Portaria. Source: Diário da RepúblicaChecked 8 October 2026 | EU Blue Card for highly qualified staff; other hires go through the salaried worker permit. Source: Guichet.luChecked 8 October 2026 |
| Talent tax regime | Special regime for inbound workers (art. 93 LIRPF), extended by Ley 28/2022 to entrepreneurs and investors. You must not have been resident in Spain in the previous 5 tax periods; it covers the year of the move and the following five. Source: La MoncloaChecked 8 October 2026 | IFICI (art. 58.º-A EBF): 20% flat rate on qualifying employment and business income for 10 consecutive years. You must not have been Portuguese tax resident in the previous 5 years. Apply by 15 January of the year after you become resident. Source: Portal das FinançasChecked 8 October 2026 | Impatriate regime reformed from 2025: 50% of gross salary exempt, capped at €400,000 a year, for salaries of at least €75,000, until the end of the eighth year. No Luxembourg residence or tax liability, and no home within 150 km of the border, in the previous 5 years. Source: Loyens & LoeffChecked 8 October 2026 |
| 5 · What you gain | |||
| Corporate tax | General corporate tax rate 25%. Certified empresas emergentes pay 15% for the first four tax periods with a positive tax base (Ley 28/2022). Source: La MoncloaChecked 8 October 2026 | IRC 19% for 2026, 18% for 2027, 17% for 2028 (Lei 64/2025). SMEs and small mid-caps pay 15% on the first €50,000. Municipal and state surcharges come on top. Source: PwC PortugalChecked 8 October 2026 | Corporate income tax 16% from 2025. With the employment fund surcharge and municipal business tax, the total in Luxembourg City is 23.87%. Source: ACD LuxembourgChecked 8 October 2026 |
| Startup status | ENISA certifies empresas emergentes: under 5 years old (7 in biotech, energy, industry), turnover up to €10m, seat or permanent establishment in Spain, at least 60% of staff on Spanish contracts, no dividends, innovative and scalable. Source: ENISAChecked 8 October 2026 | Startup and scaleup status under Lei 21/2023, certified by Startup Portugal. It unlocks IFICI for qualifying staff and board members. Source: Startup PortugalChecked 8 October 2026 | No general startup tax status equivalent to Spain or Portugal. Support runs through Luxinnovation and programmes such as Fit 4 Start. Source: LuxinnovationChecked 8 October 2026 |
| Substance | A company is Spanish tax resident if incorporated in Spain or if its effective management is in Spain. Startup certification adds its own test: seat in Spain and 60% of staff on Spanish contracts. Source: BOEChecked 8 October 2026 | A company is Portuguese tax resident if its seat or place of effective management is in Portugal. IFICI and startup status each carry their own activity checks. Source: Portal das FinançasChecked 8 October 2026 | Tax residence follows the registered office or central administration. Luxembourg looks closely at real presence: decision-makers, premises and staff on the ground. Source: ACD LuxembourgChecked 8 October 2026 |
| Public funding access | ENISA and CDTI lines need a Spanish company. EU programmes need an EU entity, which a Spanish SL provides. Source: ENISAChecked 8 October 2026 | Portugal 2030 and Startup Portugal instruments need a Portuguese entity. EU programmes need an EU entity. Source: Startup PortugalChecked 8 October 2026 | Luxinnovation and Ministry of the Economy R&D aid need a Luxembourg establishment. EU programmes need an EU entity. Source: LuxinnovationChecked 8 October 2026 |
| Where in the country | Our reading: Madrid and Barcelona concentrate investors, research hospitals and most of the private health market. Several regions run their own innovation grants, which can tip the choice. Our readingChecked 9 October 2026 | Our reading: Lisbon concentrates investors and the startup ecosystem; Porto and Coimbra have strong university hospitals and research. As a market Portugal is small, so most companies use it as a base. Our readingChecked 9 October 2026 | Our reading: there is no real choice of location inside Luxembourg. The question is whether you need Luxembourg at all, or only its finance and funding links. Our readingChecked 9 October 2026 |
AEMPS. Under Real Decreto 192/2023 (art. 7), manufacturing, importing, assembling or sterilising medical devices in Spain needs a prior operating licence (licencia previa de funcionamiento). Distributors notify the health authority of their autonomous community.
Source: AEMPSChecked 8 October 2026Since Real Decreto 415/2026, health technology assessment is organised nationally. RedETS evaluates non-drug technologies, including digital ones when the governance council agrees, and its reports inform funding decisions without binding them.
Source: BOEChecked 9 October 2026SL (sociedad limitada) from €1 of capital since Ley 18/2022. While capital is under €3,000, 20% of profit goes to the legal reserve and partners are jointly liable for the gap up to €3,000 on liquidation. SA for larger structures.
Source: BOEChecked 8 October 2026Online incorporation through CIRCE is available. Foreign directors and partners need an NIE, a foreign parent company needs a Spanish NIF, and foreign investment is declared to the Registro de Inversiones. Real cost and time not verified this round.
Source: PAE / CIRCEChecked 8 October 2026An SL is wound up by shareholder resolution, notarial deed and registration with the Registro Mercantil under the Ley de Sociedades de Capital. Official cost not confirmed.
Source: BOEChecked 9 October 2026AEPD (Agencia Española de Protección de Datos).
Source: AEPDChecked 8 October 2026Entrepreneur residence authorisation (arts. 68 to 70, Ley 14/2013) with a favourable ENISA report on the business plan. No minimum investment or job creation. A telework (digital nomad) route also exists.
Source: Ministerio de InclusiónChecked 8 October 2026Highly qualified professional authorisation and EU Blue Card, processed by the UGE.
Source: Ministerio de InclusiónChecked 8 October 2026Special regime for inbound workers (art. 93 LIRPF), extended by Ley 28/2022 to entrepreneurs and investors. You must not have been resident in Spain in the previous 5 tax periods; it covers the year of the move and the following five.
Source: La MoncloaChecked 8 October 2026General corporate tax rate 25%. Certified empresas emergentes pay 15% for the first four tax periods with a positive tax base (Ley 28/2022).
Source: La MoncloaChecked 8 October 2026ENISA certifies empresas emergentes: under 5 years old (7 in biotech, energy, industry), turnover up to €10m, seat or permanent establishment in Spain, at least 60% of staff on Spanish contracts, no dividends, innovative and scalable.
Source: ENISAChecked 8 October 2026A company is Spanish tax resident if incorporated in Spain or if its effective management is in Spain. Startup certification adds its own test: seat in Spain and 60% of staff on Spanish contracts.
Source: BOEChecked 8 October 2026ENISA and CDTI lines need a Spanish company. EU programmes need an EU entity, which a Spanish SL provides.
Source: ENISAChecked 8 October 2026Our reading: Madrid and Barcelona concentrate investors, research hospitals and most of the private health market. Several regions run their own innovation grants, which can tip the choice.
Our readingChecked 9 October 2026INFARMED. Decreto-Lei 29/2024 applies the MDR in Portugal and keeps national registration and notification duties for manufacturers, authorised representatives and distributors until EUDAMED is fully running.
Source: INFARMEDChecked 8 October 2026INFARMED runs SiNATS, which evaluates health technologies for SNS funding and handles state reimbursement (comparticipação) of some medical device categories. Decreto-Lei 118/2026 (17 June 2026) creates a new SiNATS; current rules stay in force during the transition.
Source: INFARMEDChecked 9 October 2026Sociedade por quotas (Lda): minimum €1 per quota. Sociedade anónima: minimum capital €50,000. Regulated activities can require more.
Source: Justiça.gov.ptChecked 8 October 2026Empresa Online: €220 with pre-approved articles, €360 with your own articles (double for urgent). Empresa na Hora at a counter. Non-resident partners need a Portuguese NIF, usually through a tax representative.
Source: Justiça.gov.ptChecked 8 October 2026Online closure for an Lda or SA: immediate extinction, or dissolution with closure of liquidation, €255 online (€300 in person), filed within two months of the shareholders' resolution.
Source: Justiça.gov.ptChecked 9 October 2026CNPD (Comissão Nacional de Proteção de Dados).
Source: CNPDChecked 8 October 2026StartUP Visa (IAPMEI): residence for founders whose project is hosted by a certified incubator. Lei 61/2025 changed several residence routes in October 2025, so check current conditions before applying.
Source: IAPMEIChecked 8 October 2026Highly qualified activity permits, EU Blue Card and the Tech Visa. Lei 61/2025 added a job-seeking visa for specialised technical profiles, to be defined by Portaria.
Source: Diário da RepúblicaChecked 8 October 2026IFICI (art. 58.º-A EBF): 20% flat rate on qualifying employment and business income for 10 consecutive years. You must not have been Portuguese tax resident in the previous 5 years. Apply by 15 January of the year after you become resident.
Source: Portal das FinançasChecked 8 October 2026IRC 19% for 2026, 18% for 2027, 17% for 2028 (Lei 64/2025). SMEs and small mid-caps pay 15% on the first €50,000. Municipal and state surcharges come on top.
Source: PwC PortugalChecked 8 October 2026Startup and scaleup status under Lei 21/2023, certified by Startup Portugal. It unlocks IFICI for qualifying staff and board members.
Source: Startup PortugalChecked 8 October 2026A company is Portuguese tax resident if its seat or place of effective management is in Portugal. IFICI and startup status each carry their own activity checks.
Source: Portal das FinançasChecked 8 October 2026Portugal 2030 and Startup Portugal instruments need a Portuguese entity. EU programmes need an EU entity.
Source: Startup PortugalChecked 8 October 2026Our reading: Lisbon concentrates investors and the startup ecosystem; Porto and Coimbra have strong university hospitals and research. As a market Portugal is small, so most companies use it as a base.
Our readingChecked 9 October 2026Direction de la santé. Class I devices and IVDs are registered by email before market placement. Patient information must be in French, German or Luxembourgish; English is accepted for professional-use-only devices.
Source: Guichet.luChecked 8 October 2026The CNS reimburses medical devices that appear on its lists, generally on prescription.
Source: CNSChecked 9 October 2026SARL: minimum €12,000, fully paid up at incorporation, before a notary. A simplified SARL-S exists for individuals with lower capital. SA for larger structures.
Source: Guichet.luChecked 8 October 2026Notarial deed, RCS registration and, for most commercial activity, a business permit from the Ministry of the Economy, which looks at the manager's good repute and qualifications. Real cost and time not verified this round.
Source: Guichet.luChecked 8 October 2026Dissolution is decided at an extraordinary general meeting before a notary, a liquidator is appointed, and the liquidation closes after an auditor's report: in practice at least three meetings. A company with a single shareholder can be dissolved without liquidation.
Source: Guichet.luChecked 9 October 2026CNPD (Commission nationale pour la protection des données).
Source: CNPD LuxembourgChecked 8 October 2026Self-employed permit: apply from abroad for a temporary authorisation (valid 90 days), with the Ministry of the Economy's consent where a business permit is needed; permit up to 3 years. Investor permit: €500,000 in a new Luxembourg company creating 5 jobs within 3 years, among other options.
Source: Guichet.luChecked 8 October 2026EU Blue Card for highly qualified staff; other hires go through the salaried worker permit.
Source: Guichet.luChecked 8 October 2026Impatriate regime reformed from 2025: 50% of gross salary exempt, capped at €400,000 a year, for salaries of at least €75,000, until the end of the eighth year. No Luxembourg residence or tax liability, and no home within 150 km of the border, in the previous 5 years.
Source: Loyens & LoeffChecked 8 October 2026Corporate income tax 16% from 2025. With the employment fund surcharge and municipal business tax, the total in Luxembourg City is 23.87%.
Source: ACD LuxembourgChecked 8 October 2026No general startup tax status equivalent to Spain or Portugal. Support runs through Luxinnovation and programmes such as Fit 4 Start.
Source: LuxinnovationChecked 8 October 2026Tax residence follows the registered office or central administration. Luxembourg looks closely at real presence: decision-makers, premises and staff on the ground.
Source: ACD LuxembourgChecked 8 October 2026Luxinnovation and Ministry of the Economy R&D aid need a Luxembourg establishment. EU programmes need an EU entity.
Source: LuxinnovationChecked 8 October 2026Our reading: there is no real choice of location inside Luxembourg. The question is whether you need Luxembourg at all, or only its finance and funding links.
Our readingChecked 9 October 2026Having a national data protection law that looks like the GDPR does not make a country adequate. Only a European Commission decision under art. 45 does. Without one, every transfer from the EU needs its own safeguard.
Is Europe your market or your base? How much runway does the move need, and who leads it on the ground? In what order do you appoint representatives, incorporate and sign the data clauses? The answers depend on your product, your cap table and your next round, and that is the conversation we have with founders.
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