AMNOG explained: how Germany prices a new medicine
The G-BA benefit assessment, the IQWiG comparator, and why the added-benefit rating — not your home price — sets the ceiling on German revenue.
Read →Practical guides on entering Germany and the EU — from the reimbursement and regulatory questions that decide life-sciences revenue to the strategy, cost and distribution of market entry. Filter by what you need.
The G-BA benefit assessment, the IQWiG comparator, and why the added-benefit rating — not your home price — sets the ceiling on German revenue.
Read →A CE mark lets you sell; it doesn't get you paid. How DRG / NUB and G-BA / EBM decide medtech reimbursement by care setting.
Read →Germany's app-on-prescription route through the BfArM fast-track — and why a listing is not the same as a prescription.
Read →Approval is only the entry ticket. What actually decides revenue after it — and why getting paid is a separate project.
Read →Medical devices and in-vitro diagnostics run on different regimes with different classes — and the answer changes everything downstream.
Read →GDPR, BfArM's data-security requirements and the BSI certificate — the most underestimated hurdle for non-EU digital-health companies.
Read →The continuing duties of a marketing-authorization holder: pharmacovigilance, GMP / GDP and the officers you're required to appoint.
Read →How to identify and approach the partners who actually move product — not the ones who merely hold a business card.
Read →German hospital procurement is committee-driven and slow. How access really works through purchasing groups, clinic chains and tenders.
Read →How prescription supply reaches Germany's ~18,000 pharmacies under GDP and EU serialization — and why the channel differs by product type.
Read →What Korean pharma, medtech and digital-health companies need to know before entering Germany and the EU.
Read →The outbound direction: how German life-sciences companies take products and equipment to markets abroad.
Read →Strategy, tax and structural risks for US companies establishing a presence in Germany.
Read →The outbound corridor to India — legal vehicles, the FDI route, CDSCO device licensing and the sequence that actually works.
Read →SFDA registration, the local-agent rule and why NUPCO and Vision 2030 reward localisation on the KSA corridor.
Read →The starting point: how entry, regulation and the business environment fit together for companies coming into Germany and the EU.
Read →Choosing your entry mode — distributor, branch or GmbH — and the strategic decisions before you commit.
Read →Once you're set up — distribution, sales channels and why being authorized isn't the same as getting paid.
Read →IT, pharma, logistics and construction — how the entry playbook differs across sectors.
Read →BDI, the DIHK / IHK chambers, VDMA, Bitkom and the trade fairs (MEDICA, Hannover Messe) that are often a foreign company's first route into German industry.
Read →Setup, regulatory, QMS and access costs a medical-goods company should budget — including the ones most underestimate.
Read →How to structure a German investment — tax, holding options and a market-entry review.
Read →What running a business here is actually like — the environment, employment rules, compliance and business culture once you're operating.
Read →If your product is regulated, a short session turns these questions into a plan built for your case.
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