Policy & Legislation

How the EU Corporate Sustainability Reporting Directive affects medical device manufacturers — scope, ESRS standards, double materiality, timelines, Omnibus simplification, and practical compliance steps for MedTech.

How to implement Privacy by Design principles in medical device development — covering GDPR, HIPAA, data minimization, consent management, anonymization, and the 2026 regulatory landscape for connected devices and wearables.

How much does it cost to register a medical device in Malaysia in 2026? A buyer-side breakdown of Malaysia Authorized Representative (MAR) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B and Class C/D devices, plus the CAB-MDA-MAR three-fee structure decoded.

Complete guide to Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for medical device manufacturers — how each process works, evidence requirements, timelines, the new RAPID pathway, Coverage with Evidence Development, MAC jurisdictions, and practical strategies for securing Medicare coverage.

Complete guide to Physician Payments Sunshine Act compliance for medical device manufacturers — covered recipients, reportable payment categories, 2026 thresholds, CMS submission process, state-level requirements, penalties, and audit preparation.

How much does it cost to register a medical device in Thailand in 2026? A buyer-side breakdown of Thai License Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class 1/2 listings/notifications and Class 3/4 notifications/licenses.

How much does it cost to register a medical device in the UK in 2026? A buyer-side breakdown of UK Responsible Person (UKRP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios that incorporate the new MHRA annual GMDN-category fee from April 2026.

Everything medical device manufacturers need to know about product liability — strict liability vs negligence, insurance coverage types, EU Directive 2024/2853 changes, recall coverage, and risk mitigation strategies for 2026 and beyond.

Comprehensive guide to the FDA Emergency Use Authorization (EUA) pathway for medical devices under Section 564 of the FD&C Act — legal basis, CBRN emergency triggers, statutory criteria, submission process, EUA vs 510(k)/PMA comparison, post-COVID transition framework, and current active EUAs.

Complete guide to FDA medical device advertising and promotion regulations — 21 CFR Part 801 labeling requirements, OPEQ enforcement, off-label promotion rules, social media compliance, FTC oversight, warning letters, and practical strategies for compliant promotional claims.

Complete guide to laboratory developed test regulation in 2026 — FDA's vacated 2024 final rule, the ACLA court decision, current CLIA oversight, enforcement discretion status, and what laboratories must do now.

How US tariffs, EU-China trade tensions, and Mexico's new tariff law are reshaping global medtech supply chains in 2026 — with real financial impacts from J&J, Intuitive Surgical, Boston Scientific, and practical strategies for manufacturers.

How Saudi Arabia's HSTP (290 hospitals privatized, private sector 40% to 65%, SAR 260B health budget, LCGPA 40% local content, NIDLP 40% pharma localization) and UAE's Operation 300bn (AED 300B industrial GDP target, DHCC 100% foreign ownership, EDE regulatory framework) are reshaping medical device market entry across the Gulf.

An in-depth analysis of how the Federal Trade Commission is reshaping medtech dealmaking — from blocking the Edwards/JenaValve TAVR deal to the GTCR/Surmodics outcome, HSR filing changes, and the rise of state-level mini-HSR laws.

A comprehensive roundup of the most impactful medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends shaping 2026 — and what to prepare for in 2027.

Navigate the evolving medical device legislative landscape — from MDUFA V and the VALID Act to EU MDR implementation challenges, AI regulation, and global policy trends reshaping how devices reach patients.