Germany is the largest market in Europe and the natural gateway to the EU — but entering it is not a formality. The strategy, the legal structure, the regulatory approval and, above all, reimbursement are separate decisions, and the gap between "allowed to sell" and "actually paid" is where foreign companies stall. We plan and run that entry, end to end.
Most foreign companies arrive with the product solved and underestimate everything after it. In Germany the permission to sell and the right to be paid are decided by different institutions, on different evidence, at different times.
A German market-entry strategy is not a single document — it is a sequence of decisions: how you enter (distributor, branch or your own GmbH), the legal representation the law requires, the regulatory route your product takes, and how the statutory system will reimburse it. Get the order wrong and you burn cash between approval and revenue. Get it right and Germany becomes the base for the whole EU.
In Germany, being authorized is not the same as being paid. Plan for the second, not just the first.
The sequence we run on every engagement. The discipline is starting the later steps — especially reimbursement — before the earlier ones are finished.
Read the market and pick how you enter — distributor, branch or your own GmbH — against your ambition, budget and control needs. See the entry modes compared in how to enter the German market.
Set up the entity or the representation the law requires — for regulated products, an EU Authorised Representative, responsible persons or a marketing-authorisation holder. More in local representation in Germany.
Take your product's route to market — CE marking under MDR/IVDR for devices, marketing authorisation for medicines, sector rules for everything else. This is permission to sell, not a guarantee of revenue.
The step foreign teams miss. In life sciences this is AMNOG pricing for drugs and DRG/NUB for devices; in every sector it is who pays and how. See why authorized isn't paid.
Find the distributors, hospitals or buyers who actually move product, contract them well, and launch with a first-year plan. See finding the right distributor.
Your entry mode shapes cost, control and speed. Most foreign companies blur these three — and only some satisfy the legal and commercial requirements for a regulated product.
| Distributor / partner | Branch | Own entity (GmbH) | |
|---|---|---|---|
| Setup cost & speed | Lowest, fastest | Medium | Highest, slowest |
| Control of the market | Low — partner-led | Medium | Full |
| Who holds the customer | The distributor | You | You |
| Local substance / tax | None of yours | Limited presence | Full establishment |
| Best when | Testing demand, fast reach | Sales presence, light footprint | Long-term commitment, control |
There is no universally right answer — only the right answer for your product, margin and time horizon. A distributor who holds your registration or your customers can be expensive to unwind later. We help you choose deliberately, not by default.
Typical durations for the steps most foreign life-sciences companies go through. They run partly in parallel; the regulatory and reimbursement steps, not the company setup, set the pace.
| Step | Typical duration | Main cost driver |
|---|---|---|
| German subsidiary (GmbH) — notary, commercial register, bank, tax number | 2–6 weeks | EUR 25,000 share capital (at least half paid in at registration), notary and register fees, advisers |
| EU representation — Authorised Representative, PRRC, or EEA marketing-authorisation holder | 2–8 weeks to contract | Ongoing annual service fee; liability scope |
| Medical devices — MDR / IVDR conformity assessment with a Notified Body (class IIa and up) | Often 12–18+ months | Notified Body fees, technical documentation, clinical evidence |
| Medicines — EU centralised marketing authorisation | About 210 active days plus clock stops — typically a year or more | Dossier, studies, EMA fees |
| AMNOG — benefit assessment and price negotiation for a new medicine | G-BA decision about 6 months after launch; negotiated price applies from month 7 | Benefit dossier, comparator strategy, negotiation |
| DiGA — BfArM fast-track for digital health apps | Decision within 3 months of a complete application; provisional listing for 12 months to prove the effect | Study design, BSI data security, evidence |
| Hospital NUB — extra payment for a new method | Hospitals apply by 31 October; InEK status by 31 January; then local negotiation | Hospital champions, evidence, yearly re-application |
| Hilfsmittelverzeichnis — listing of medical aids for statutory insurance | Decision within 3 months of a complete application (often longer with queries) | Proof of function, quality and benefit; insurer contracts |
| First hires | Weeks to months | No at-will employment; employer social costs of roughly 20% on top of salary |
Durations are typical ranges, not guarantees, and depend on product class, evidence and the authority. For a detailed budget view see the real cost of entering Germany; for reimbursement timing by care setting see medical device reimbursement and AMNOG explained.
None of these are dealbreakers. All of them catch out companies that plan for the product and not the system around it.
Approval or a CE mark lets you sell; a separate system decides if and how you get paid. This is the barrier that quietly stalls launches.
Regulated and non-EU companies need named, liable local representation before a product can be placed on the market at all.
There is no at-will employment, and an active local presence can create a taxable permanent establishment. Structure it on purpose.
Data protection is stricter than US norms and a design constraint for connected and digital products, not a late compliance step.
Hospital and public buying is committee-driven, tender-heavy and slow — a listing or a code is not the same as an order.
Relationships, references and associations open doors. See industry associations & networks.
We help companies across sectors enter Germany, but our edge is the hard, regulated corner — where the barrier is real and a local guide is not optional.
Marketing authorisation, then the pricing that AMNOG and the G-BA actually set.
AMNOG explained →MDR/IVDR, CE marking and DRG/NUB hospital reimbursement.
Device reimbursement →The BfArM fast-track to a prescribable, reimbursed app — and its catch.
DiGA route →Coming from a specific country? See the tailored guides for US and Swiss life-sciences companies, or the full insights library.
We own the commercial and access layer and orchestrate the regulatory, legal and reimbursement specialists into one plan — so a first-time entrant is not stitching vendors together alone.
The read, the entry mode, the structure and a sequenced plan — a roadmap you can act on, not a slide deck.
The entity or the representation the law requires, stood up and kept compliant as you sell. See local representation.
Pricing, reimbursement and the partners, payers and hospitals that turn approval into revenue.
In five steps: decide the strategy and entry mode (distributor, branch or GmbH), set up the legal footing and any required representation, take your product's regulatory route to approval, secure reimbursement so you actually get paid, and appoint the partners or channels that reach customers. The mistake to avoid is treating approval as the finish line — reimbursement is a separate project.
It depends on control, cost and commitment. A distributor is fastest and cheapest but hands the market to a partner; a branch gives a sales presence with a lighter footprint; your own GmbH gives full control and local substance at the highest cost. For regulated products the choice also affects who can legally hold your registration.
Often, yes. Non-EU manufacturers of regulated products need EU representation — an Authorised Representative and responsible persons for devices, or an EEA-based marketing-authorisation holder for medicines — before the product can be placed on the market. A distributor does not discharge that obligation.
The biggest is reimbursement: approval lets you sell, but a separate system decides whether and how you are paid. Others include mandatory legal representation, strict employment law, the permanent-establishment tax trap, GDPR, and slow committee-driven procurement.
It varies widely by product, entry mode and regulatory route. The costs foreign companies most underestimate are regulatory, quality-system and market-access — not the entity setup. We map the realistic budget for your case; see the real cost of entering Germany.
It is the largest single market in the EU, and for many regulated products an approval obtained via Germany opens the wider single market. A German base gives a credible EU footing to expand from — in both directions.
Setting up a GmbH takes a few weeks. What sets the real timeline is the product: MDR/IVDR certification often takes 12–18 months or more, a centralised medicine approval a year or more, and reimbursement adds its own cycle — about 6 months for an AMNOG decision, an annual cycle for hospital NUB funding. Plan in parallel, not in sequence.
Yes. There is no nationality or residence requirement for shareholders or managing directors. In practice you need a notarised formation (possible abroad via a German consulate or apostilled documents), a German business bank account and an entry in the transparency register. US companies: see setting up a German subsidiary.
For the market, largely yes. Device labelling and instructions for use must be in German, payers and hospitals negotiate in German, and national authorities often expect German documents. Many EU-level submissions accept English — the market itself runs in German, and industry associations and chambers are where many first contacts start.
Start with a focused session — you'll leave with the entry mode, the structure and the reimbursement path mapped for your specific product.