Welcome to HealthTech Go Global!
Thanks for boarding this new flight-plan for founders, investors, and regulators who believe life-saving tech shouldn’t stop at a border. Each fortnight you’ll get a five-minute scan of the regulatory moves, market doors, and funding pulses that matter most when you’re scaling health innovation worldwide.
1️⃣ Fresh Rulebook — AI & Software
The U.S. FDA opened 2025 by releasing draft guidance on lifecycle management and submission requirements for AI-enabled device software functions. Expect heavier evidence expectations, a push for real-world-performance monitoring, and clearer pathways for rapid algorithm updates.
Just yesterday the agency also re-issued its pre-market cybersecurity guidance, tightening requirements for Software Bills of Materials (SBOMs) and threat-mitigation controls.
Take-away: Bake continuous monitoring and SBOM tooling into your dev budget now—retrofits cost more.
2️⃣ Europe Tightens—and Digitises—Access
Digital IFU shortcut: On 25 June the European Commission green-lit simplified electronic instructions-for-use, signalling Brussels’ intent to accelerate paper-free devices while keeping MDR safety nets.
Procurement shock: A week earlier the EU barred most Chinese suppliers from high-value public-hospital tenders, invoking its new International Procurement Instrument. If your supply chain relies on China for >50 % component value, start contingency planning.
Playbook tip: For non-EU firms, the digital IFU decision is your opening—pair a Notified-Body-approved e-labelling strategy with localisation partners and you’ll shave months off launch timelines.
3️⃣ WHO Signals Demand for Assistive & Controlled-Medicine Tech
The WHO updated two lists this spring: a Priority Assistive Products List (APL) and new guidelines on access to controlled medicines, nudging governments to expand reimbursement and procurement.
Translation: Funding for low-vision aids, mobility devices, and opioid-monitoring tech could rise fast in emerging markets—prime ground for nimble scale-ups.
Quick-Win Checklist ✅
Do this this week
Audit SBOM readiness: Map every third-party library; label “critical” vs. “nice-to-have.”
Model EU content split: Calculate non-Chinese component share to stay <50 % for EU tenders.
Tag assistive features: Align product road-map with the new WHO APL to unlock grants.
Hit Subscribe (and share!) if you want to turn red-tape into runway. Got a question you’d like decoded in the next issue? Comment or DM—I read every note.
Need help with global market access? Connect with Pure Global at pureglobal.com or email info@pureglobal.com. With offices spanning the Americas, Europe, and Asia, our multilingual team has guided hundreds of health-tech innovators through every major regulatory system. Partner with the experts trusted for speed, compliance, and seamless worldwide launch.