Medical Device Global Market Access

This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant bottlenecks in audit scheduling and technical documentation review are creating a "timeline compression" risk. We explore why manufacturers must strategically prioritize their product portfolios and engage with Notified Bodies much earlier than pl...

This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. We explore the potential impacts on documentation, digitalization through EUDAMED, and what these changes could mean for manufacturers, especially SMEs, as they navigate the complex European regulatory landscape. Key Questions: - What specific changes...

This episode unpacks the critical amendments introduced by Regulation (EU) 2024/1860, focusing on the new obligations for medical device manufacturers to notify authorities about supply interruptions and discontinuations. We explore why this has become a major compliance challenge, touching on its impact on portfolio management, distributor relations, and the necessity for early risk detection sys...

This episode details the crucial extension of the In-Vitro Diagnostic Regulation (IVDR) transition periods under the EU's Regulation 2024/1860. We explore the specific, time-sensitive conditions manufacturers must meet to benefit from this extension, including Quality Management System requirements and mandatory engagement with a Notified Body. This is essential information for any IVD manufacture...

This episode details the crucial update on the EUDAMED gradual roll-out. We explain the impact of the European Commission's Implementing Decision (EU) 2025/2371, which confirms the functionality of the first four EUDAMED modules. The discussion covers which modules are now live, the official start date for mandatory use—May 28, 2026—and what actions medical device and IVD manufacturers must take t...

This episode provides a detailed overview of Mexico's three-tiered medical device classification system managed by COFEPRIS. We explore how Class I, Class II, and Class III devices are defined by risk and highlight the key differences between Mexico's framework and the systems used by the US FDA and the European Union. Understanding these nuances is the critical first step for successful market en...

This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPRIS registration system. We explain why the differing regulatory frameworks, classification rules, and risk criteria make a direct transfer impossible and discuss the severe consequences of such a mistake, including immediate rejection, costly delays,...

This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the specifics of COFEPRIS's three-tier classification system, highlighting its key differences from Korea's four-class MFDS framework. Listeners will learn why misclassification is a primary cause of submission rejections and how a strategic approach to devic...

This episode explores the transformative Abbreviated Regulatory Pathway being launched by Mexico's COFEPRIS in September 2025. We detail how this new 30-day process specifically benefits Korean medical device manufacturers holding MFDS approval, outlining the immense opportunity for accelerated market entry. The discussion also covers critical challenges, such as proving product equivalency and na...

This episode explains the mandatory requirement for foreign medical device manufacturers to appoint a Mexico Registration Holder (MRH) to register products with COFEPRIS. It highlights the specific challenges Korean companies face in finding a reliable partner and the risks of appointing a distributor for this role. The host details how a dedicated, professional MRH provides a secure and compliant...

This episode focuses on the single most critical challenge for Korean medical device companies entering the Mexican market: the stringent Spanish language requirements mandated by the regulatory authority, COFEPRIS. We explore how this impacts the entire registration process, from technical documentation to labeling, and why overcoming this linguistic barrier is fundamental for successful market a...

This episode explores why Brazil is a critical entry point for Korean medical device companies looking to expand into South America. We discuss how to leverage Brazil's position within the MERCOSUR trade bloc to access markets like Argentina, Paraguay, and Uruguay, turning a single-country registration into a regional strategy. - Why is Brazil more than just a large domestic market for Korean medi...

This episode provides a strategic overview for Korean medical device companies targeting the Brazilian market. We explore the critical process of navigating Brazil's Unified Health System (SUS) to gain market access and secure reimbursement. The discussion covers the key differences between Brazil's public tender process and Korea's HIRA system, recent modernizing changes by ANVISA that impact int...

This episode explores the critical cultural challenges Korean medical device companies face when entering the Brazilian market. We delve into why a transactional business approach often fails and highlight the paramount importance of relationship-building, patience, and understanding Brazil's unique business etiquette for a successful market entry. Key Questions - Why do fast-paced Korean business...

This episode explores the significant regulatory hurdles Korean medical device manufacturers face when entering the Brazilian market. We detail the extended approval timelines and unpredictable delays from Brazil's ANVISA, contrasting them with the more streamlined processes of Korea's MFDS. Learn about the different registration pathways for various device classes and the strategic adjustments ne...

This episode delves into the single most critical requirement for Korean medical device manufacturers entering the Brazilian market: providing proof of country of origin market authorization. We explain why Brazil's ANVISA requires official approval from Korea's Ministry of Food and Drug Safety (MFDS) and how this documentation serves as vital evidence of a device's safety and efficacy. We also ex...

This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for electro-medical devices. We break down why this certification, which requires local testing in Brazil, is often an unexpected challenge for manufacturers accustomed to the MFDS system. We cover the specific devices affected, the typical tim...

This episode delves into the single most significant barrier for Korean medical device manufacturers entering the Brazilian market: the intricate and burdensome import taxation system. We break down the multiple federal and state-level taxes—including II, IPI, PIS, COFINS, and ICMS—that can collectively exceed 60% of a product's value, and explain why a nuanced understanding of landed costs and pr...

This episode details the single most critical challenge for Korean medical device manufacturers entering Brazil: ANVISA's strict Portuguese-only documentation requirement. We explore why this is a major hurdle, how it differs from Korea's MFDS policies, and the significant risks of improper translation, including costly delays and registration failures. Key Questions: - Why is entering the Brazili...

This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We detail the mandatory B-GMP requirements for Class III and IV devices and compare the two main compliance pathways. Discover the significant time and cost advantages of leveraging MDSAP certification, which can extend certificate validity to...

This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory appointment of a Brazilian Registration Holder (BRH). We delve into why foreign companies cannot register directly with ANVISA, contrast Brazil's system with Korea's MFDS, and outline the extensive legal and operational responsibilities of a BRH, fr...

This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of lega...

This episode provides a comprehensive guide to the regulatory landscape for dental devices in Mexico. We delve into the role of the national regulatory body, COFEPRIS, and explore the classification system for dental equipment and supplies. The discussion covers the essential requirements for market entry, including the mandatory appointment of a Mexican Registration Holder (MRH), the different re...

This episode provides a detailed guide for dental device manufacturers on navigating the regulatory landscape in Mexico. We cover the role of the national authority, COFEPRIS, the critical process of appointing a Mexico Registration Holder (MRH), device classification, and the strategic advantages of using the Equivalency Pathway for faster market approval. We also discuss essential post-market ob...

This episode explores the strategic pathway for bringing dental devices to the Mexican market. We delve into the regulatory framework managed by COFEPRIS, the risk-based device classification system, and the critical role of a local partner or Mexican Registration Holder (MRH). Learn how leveraging existing approvals from the USA, Canada, or Japan can create an efficient entry strategy and what po...