12 August 2026
The 5 most entry-ready markets for medical devices right now
For a Class II device, the fastest routes belong to the markets that let you build on an approval you already hold.
The Index
12 August 2026
The single requirement that decides entry in 6 large markets
Six large markets, each decided by one specific requirement, and usually not the one companies screen for.
Market Watch
17 October 2026
Market Watch: the pharmaceutical tariff now reaches every importer
The 100 percent Section 232 tariff extended to all companies on 29 September, and Commerce published the architecture that decides who pays nothing.
14 October 2026
Market Watch: CMS finalised GLOBE, and cut it
International reference pricing enters Medicare Part B by final rule, with a later start and a much shorter list of drugs than proposed.
15 August 2026
Market Watch: the US put a 100 percent tariff on patented medicines
A 100 percent tariff on imported patented medicines is operative for a first group of companies, and applies to everyone else from 29 September.
14 August 2026
Market Watch: WHO and the African Medicines Agency signed a reliance framework
WHO and the African Medicines Agency signed a framework to drive regulatory reliance across the continent.
13 August 2026
Market Watch: Vietnam opens a reliance route for six regulators
An abbreviated assessment route opens for products already approved by one of six named authorities.
12 August 2026
Market Watch: the UK raised its cost-effectiveness threshold
NICE's cost-effectiveness range moved for the first time in two decades, and the Secretary of State can now direct it.
26 July 2026
Market Watch: the UK reliance pathway excludes the EU
A new GB route recognises US, Canadian and Australian approvals. Not European ones.
Analysis
26 August 2026
Launch order has quietly become a pricing decision
Under most-favored-nation and reference pricing, the order of entry has become a pricing decision.
19 August 2026
A URL is not a citation
Peer review assumed a human made the analytic decisions and could reconstruct them. That assumption no longer holds.
12 August 2026
The cheapest line in your model is the one nobody owns
Tax and customs is the sixth dimension of market entry, and the one almost no assessment measures.
11 August 2026
Your first launch price is an input to every price that follows
External reference pricing is a sequencing constraint, not a fact of life.
23 July 2026
Regulatory reliance is a strategy, not a shortcut
The approval you already hold determines which markets open next.
Autopsies
24 August 2026
Distributor lock-in: when the registration is not in your name
The registration was never in the company's name, and the company only discovered that when it tried to leave.
21 August 2026
The sequence error: when an early price sets a later one
A price agreed in a small early market travelled, by rule, into every market the company had been saving.
17 August 2026
Approved but unpaid: when clearance does not convert to revenue
The company optimised for the regulator, then met a second decision maker it had never designed evidence for.
24 July 2026
Market entry autopsy: the reference-pricing withdrawal
A therapy withdrawn from a market that had done nothing wrong.