Podcast Episodes
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EU MDR & IVDR Simplification: What the 2025 Proposal Means for MedTech
This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. W…
8 months, 2 weeks ago
EU Supply Chain Alert: Navigating Medical Device Shortage Notifications Under Regulation 2024/1860
This episode unpacks the critical amendments introduced by Regulation (EU) 2024/1860, focusing on the new obligations for medical device manufacturer…
8 months, 3 weeks ago
EU IVDR Extension: Key Conditions & Deadlines Under Regulation 2024/1860
This episode details the crucial extension of the In-Vitro Diagnostic Regulation (IVDR) transition periods under the EU's Regulation 2024/1860. We ex…
8 months, 3 weeks ago
The EUDAMED Clock is Ticking: Understanding the EU's Mandatory 2026 Deadlines
This episode details the crucial update on the EUDAMED gradual roll-out. We explain the impact of the European Commission's Implementing Decision (EU…
8 months, 3 weeks ago
COFEPRIS Uncovered: Comparing Mexico's Device Classification to FDA and EU Rules
This episode provides a detailed overview of Mexico's three-tiered medical device classification system managed by COFEPRIS. We explore how Class I, …
8 months, 3 weeks ago
MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico
This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPR…
8 months, 3 weeks ago
Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping
This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the spec…
8 months, 3 weeks ago
COFEPRIS & MFDS: A New 30-Day Fast-Track for Korean MedTech in Mexico
This episode explores the transformative Abbreviated Regulatory Pathway being launched by Mexico's COFEPRIS in September 2025. We detail how this new…
8 months, 3 weeks ago
Mexico's COFEPRIS Regulations: A Guide for Korean MedTech on Appointing a Mandatory Registration Holder (MRH)
This episode explains the mandatory requirement for foreign medical device manufacturers to appoint a Mexico Registration Holder (MRH) to register pr…
8 months, 4 weeks ago
Cracking COFEPRIS: Spanish Language Strategy for Korean MedTech in Mexico
This episode focuses on the single most critical challenge for Korean medical device companies entering the Mexican market: the stringent Spanish lan…
8 months, 4 weeks ago