Practice · China ⟶ Europe · 中国企业出海欧洲

CE marking is the easy part.

Europe is not one market. It is twenty-seven health systems, two funding models and a dozen reimbursement logics. The question is never “can we be approved” — it is “where do we start, and with whom”.

Europe Discovery is a designed visit — three to five days of meetings with the institutions, industrial players and clinicians who decide whether Europe works for you, arranged under our name.

Why Europe

A mature market that pays for evidence

  • Twenty-seven countries with advanced health systems and public funding.
  • Per-capita health spending above USD 4,000 — the highest of any region.
  • Populations aged 65+ at roughly 20% in Germany, France and Italy, driving chronic-care and rehabilitation demand.
  • The world’s second medical-device market: about 27% of global share.
  • European approval is a credential that travels — it opens the Middle East, Latin America and Southeast Asia.

Two funding logics, not one

The Beveridge model — the UK, Italy, Spain, Portugal and the Nordics — funds care from taxation through public facilities. The Bismarck model — Germany, Austria, Switzerland, the Czech Republic — runs on insurance funds. France, the Netherlands, Hungary and Slovakia mix the two.

Which model your first country uses changes who buys, how price is set, and how long approval to revenue actually takes. Choosing the wrong first country is the most common and most expensive European mistake.

Where the money comes from

Three funding logics across the Union

Beveridge — funded by taxation Bismarck — insurance funds Mixed GermanyFranceItalySpainNetherlandsPolandBelgiumSwedenAustriaDenmarkFinlandPortugalCzechiaGreeceHungaryIrelandSlovakiaNorwaySwitzerlandLuxembourg
The funding model of your first country decides who buys, how price is set, and how long approval takes to become revenue. A selection of 20 markets; the Union counts 27.

The route

Eighteen to thirty-six months, in four overlapping stages

061218243036 Market study Regulatory registration Distribution & pricing Pharmacovigilance ongoing Months from decision
The stages overlap. The most common mistake is waiting for registration to close before starting the distributor search. Indicative and non-contractual: every product requires its own assessment.

The route

Eighteen to thirty-six months, in four stages

Stage 1

Market study

Country prioritisation, segment sizing, competitive and pricing landscape, distribution mapping.

Stage 2

Regulatory registration

CE marking, MDR / IVDR technical file, authorised representative, EMA or national authorisation.

Stage 3

Distribution & pricing

Distributor identification and qualification, pricing and reimbursement agreements, first accounts.

Indicative and non-contractual. Every product requires its own assessment. A fourth stage — pharmacovigilance and post-market surveillance — runs continuously from launch.

Why us

We are not a certification bureau

Plenty of firms will file your CE dossier. Very few can tell you which German purchasing group matters, why a Spanish tender behaves differently from an Italian one, or how a French hospital actually decides.

01

European offices, not a European desk

Paris and Valencia. Our people are in the market you are entering, in the language of the people you need.

02

Chinese leadership

Partners who have run pharmaceutical and device businesses in China, and who work in Mandarin with your team.

03

Fourteen years of two-way traffic

We have moved European companies into China since 2012. We know both customs procedures — and both business cultures.

Start with a look, not a commitment

Most of our Chinese clients begin with the Europe Discovery programme — a designed encounter with the institutions, innovators and industrial players that will decide whether Europe works for you.