01 · Synthesis
The period's patterns, distilled to 4–5 load-bearing takeaways.
MedTech Regulatory Intelligence Digest
Global Regulations Intelligent Report
RegTalk Digest is Arazy Group's curated intelligence digest for medical device, IVD, and SaMD teams. We track framework-level change across 140+ markets, scope-filter the noise, and tell you what to do about it — every week and every month.
140+ countries31 years regulatory expertise5,000+ registration activities
RegTalk Monthly Digest
May 31, 2026
CRITICALEUDAMED four-module mandatory-use takes effect
Why this matters: Unregistered devices risk losing EU market access. Complete Actor Registration now.
CRITICALFDA Human Factors final guidance published
Why this matters: Submissions after Aug 1 must adopt the new HF Submission Category decision point.
STRATEGICMexico NOM-137 labeling standard published
Why this matters: 12-month window opens for label, IFU, and contra-labeling rework.
Why RegTalk Digest
Regulatory intelligence built by operators, not aggregators
Most alerts bury you in headlines. RegTalk filters to what governs your portfolio — then tells you who's impacted and what to do.
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Scope-filtered, not noise
Every item is filtered to medical devices, IVDs, SaMD, and drug-device combinations, then tiered CRITICAL or STRATEGIC. No pharma, no cosmetics, no scroll-through.
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"Why this matters," every time
We don't just report the rule change. Each item carries an operational read: who's impacted, the action required, and the deadline that drives it.
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Global by default
EUDAMED, FDA, COFEPRIS, NMPA, TGA, SFDA and more — grouped by trade bloc so one digest covers the markets your portfolio actually spans.
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From the LICENSALE® team
Produced by Arazy Group — 31 years and 5,000+ registration activities across 140 countries, behind LICENSALE® and REGISLATE®.
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- Everything in Weekly, synthesized for the month
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- Cross-jurisdictional pattern analysis
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What's inside every issue
A consistent, decision-ready structure
Open it and go straight to what changed and what it means — no reformatting between issues.
02 · Intelligence Detail
Item-by-item by jurisdiction, tagged CRITICAL / STRATEGIC.
03 · Upcoming Deadlines
Date, jurisdiction, who's impacted, action required.
04 · Macro-Trend Watch
Durable cross-market themes with a 6–12 month outlook.
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Product categoriesIVDs, SaMD
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