Shows / Medical Device Global Market Access
Medical Device Global Market Access
Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other…
Episodes
- Medical Device Global Market Access
Singapore HSA Fees: A Cost Breakdown for Class B, C, & D Medical Device Registration
This episode provides a detailed breakdown of the medical device registration fees charged by Singapore's Health Sciences Authority (HSA). We cover the…
- Medical Device Global Market Access
Singapore MedTech Compliance: Mastering the SS 620 GDPMDS Standard for Device Distribution
This episode provides a detailed overview of Singapore's mandatory Good Distribution Practice for Medical Devices (GDPMDS) certification. We explore the…
- Medical Device Global Market Access
Singapore MedTech Market: A Guide to HSA's Importer, Wholesaler & Manufacturer Licenses
This episode provides a detailed guide to the three types of medical device dealer licenses required by Singapore's Health Sciences Authority (HSA)…
- Medical Device Global Market Access
Navigating Singapore's HSA: The Class A Medical Device Registration Exemption
This episode delves into a key regulatory pathway in Singapore for low-risk medical devices. We explore the Health Sciences Authority's (HSA) exemption from…
- Medical Device Global Market Access
Unlocking Singapore: Mastering the ASEAN CSDT for Medical Device Registration
This episode provides a detailed guide on using the ASEAN Common Submission Dossier Template (CSDT) for medical device registration in Singapore. We cover the…
- Medical Device Global Market Access
Singapore HSA Fast-Track: Leveraging FDA, CE Mark & TGA Approvals for Device Registration
This episode explores Singapore's Health Sciences Authority (HSA) abridged evaluation route, a streamlined pathway for medical device registration. We detail…
- Medical Device Global Market Access
Singapore MedTech Compliance: Navigating HSA Registrant & Representative Roles
This episode details the mandatory requirement for foreign medical device manufacturers to appoint a Singapore Registrant. We explain the role and…
- Medical Device Global Market Access
Singapore HSA Pathways: A Guide to Immediate, Expedited & Abridged MedTech Registration
This episode provides a detailed guide to the Singapore Health Sciences Authority (HSA) medical device registration pathways for Class B, C, and D devices. We…
- Medical Device Global Market Access
Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)
This episode provides a detailed guide to Singapore's Health Sciences Authority (HSA) medical device risk classification system. We explore the four-tier…
- Medical Device Global Market Access
Singapore Medical Device Registration: Navigating the HSA & Health Products Act
This episode provides a detailed overview of Singapore's medical device registration framework. We cover the role of the Health Sciences Authority (HSA), the…
- Medical Device Global Market Access
Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation
This episode provides a detailed overview of the regulatory requirements for medical device labeling, Instructions for Use (IFU), and Spanish translation for…
- Medical Device Global Market Access
Colombia's INVIMA Medical Device Registration: A Breakdown of Government Fees and Ongoing Costs
This episode provides a detailed breakdown of the costs associated with registering a medical device in Colombia with the regulatory authority, INVIMA. We…
- Medical Device Global Market Access
Colombia's INVIMA Registration: Is FDA or CE Mark Approval a Must?
This episode explores the requirements for medical device registration in Colombia, focusing on whether prior approval from a reference country like the US or…
- Medical Device Global Market Access
Colombia INVIMA Medical Device Registration: Technical Files, CFS, and Apostille Requirements
This episode provides a detailed guide on the essential documents required for medical device registration in Colombia through the regulatory body, INVIMA. We…
- Medical Device Global Market Access
Colombia's INVIMA Approval Timelines: Standard vs. Expedited Medical Device Pathways
This episode explores the medical device registration process in Colombia, focusing on the timelines set by the regulatory authority, INVIMA. We break down the…
- Medical Device Global Market Access
Colombia's INVIMA Regulations: Legal Representative Duties for Medical Device Registration
This episode details the mandatory requirement for a local authorized representative for medical device registration in Colombia. We explore the legal…
- Medical Device Global Market Access
Colombia's Medical Device Classification: Navigating INVIMA's Risk Rules for Class I to III Devices
This episode provides a detailed overview of Colombia's medical device risk classification system as regulated by INVIMA under Decree 4725 of 2005. We explain…
- Medical Device Global Market Access
Colombia's INVIMA: Medical Device Registration Pathways and Timelines
This episode provides a comprehensive guide for foreign medical device manufacturers on registering their products in Colombia. We cover the role of the…
- Medical Device Global Market Access
EU MDR & IVDR Readiness: Mastering Economic Operator and PRRC Roles
This episode breaks down the critical responsibilities of Economic Operators—Manufacturer, Authorised Representative, Importer, and Distributor—and the Person…
- Medical Device Global Market Access
MedTech's Sustainability Dilemma: Reprocessing, Risk, and the Future of Single-Use Devices
This episode explores the growing tension between single-use medical devices and the push for sustainability. We delve into the complex world of reprocessing…
- Medical Device Global Market Access
Unlocking European Markets: Companion Diagnostics (CDx) Strategy Under IVDR
This episode details the significant regulatory complexities for Companion Diagnostics (CDx) under the European Union's In Vitro Diagnostic Regulation (IVDR)…
- Medical Device Global Market Access
EU IVDR Clarity: Navigating IVD Performance Studies with MDCG 2025-5
This episode demystifies the requirements for In-Vitro Diagnostic (IVD) performance studies under the EU's IVDR. We explore the crucial guidance document, MDCG…
- Medical Device Global Market Access
Navigating EU IVDR: A Deep Dive into Performance Evaluation for High-Risk IVDs
This episode provides a detailed breakdown of the three pillars of performance evaluation required under the EU's In Vitro Diagnostic Regulation (IVDR)…
- Medical Device Global Market Access
EU Medical Device Cybersecurity: Navigating MDCG 2019-16 Under MDR & IVDR
This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the art" as…
- Medical Device Global Market Access
EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices
This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations…
- Medical Device Global Market Access
EU SaMD Regulations: Mastering App Store Compliance and 'Making Available' Rules
This episode explores the critical new regulatory focus from Europe's Medical Device Coordination Group (MDCG) on Software as a Medical Device (SaMD)…
- Medical Device Global Market Access
EU Legacy Devices: Navigating the 'Significant Change' Maze Under MDR & IVDR
This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore the…
- Medical Device Global Market Access
Beyond the Barcode: Mastering MedTech UDI for EUDAMED & Global Markets
This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers that go…
- Medical Device Global Market Access
EU MDR Vigilance & Trend Reporting: A Deep Dive into CAPA and FSCA Decisions
This episode explores the critical operational hotspots in medical device vigilance under regulations like the EU MDR. We examine the pressures for faster…
- Medical Device Global Market Access
Beyond the Plan: Mastering PMS and PMCF Execution Under EU MDR
This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodies and…
- Medical Device Global Market Access
EU MDR Clinical Evidence: Mastering CERs, PMCF, and Equivalence Arguments
This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore the top…
- Medical Device Global Market Access
EU MDR & IVDR Certification: Navigating the Notified Body Capacity Crunch and Timeline Compression
This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant…
- Medical Device Global Market Access
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. We explore…
- Medical Device Global Market Access
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 manufacturers to…
- Medical Device Global Market Access
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 explore the…
- Medical Device Global Market Access
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)…
- Medical Device Global Market Access
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, Class II…
- Medical Device Global Market Access
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 COFEPRIS…
- Medical Device Global Market Access
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 specifics of…
- Medical Device Global Market Access
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 30-day…
- Medical Device Global Market Access
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 products…
- Medical Device Global Market Access
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 language…
- Medical Device Global Market Access
Brazil & MERCOSUR: A Strategic Gateway for Korean MedTech
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…
- Medical Device Global Market Access
Brazil's SUS & ANVISA: A Guide for Korean MedTech
This episode provides a strategic overview for Korean medical device companies targeting the Brazilian market. We explore the critical process of navigating…
- Medical Device Global Market Access
Korea to Brazil: Bridging the Cultural Divide in MedTech Business
This episode explores the critical cultural challenges Korean medical device companies face when entering the Brazilian market. We delve into why a…
- Medical Device Global Market Access
Korea to Brazil: Navigating ANVISA's Extended Medical Device Registration Timelines
This episode explores the significant regulatory hurdles Korean medical device manufacturers face when entering the Brazilian market. We detail the extended…
- Medical Device Global Market Access
ANVISA's Gateway to Brazil: Why Korean MFDS Approval is Non-Negotiable
This episode delves into the single most critical requirement for Korean medical device manufacturers entering the Brazilian market: providing proof of country…
- Medical Device Global Market Access
Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers
This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for…
- Medical Device Global Market Access
Cracking the Code: Brazil's Complex Import Taxes for Korean MedTech
This episode delves into the single most significant barrier for Korean medical device manufacturers entering the Brazilian market: the intricate and…
- Medical Device Global Market Access
Brazil's ANVISA: The Portuguese Language Barrier for Korean MedTech
This episode details the single most critical challenge for Korean medical device manufacturers entering Brazil: ANVISA's strict Portuguese-only documentation…
- Medical Device Global Market Access
Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification
This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We…
- Medical Device Global Market Access
Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)
This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory…
- Medical Device Global Market Access
EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access
This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the…
- Medical Device Global Market Access
Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico
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…
- Medical Device Global Market Access
Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval
This episode provides a detailed guide for dental device manufacturers on navigating the regulatory landscape in Mexico. We cover the role of the national…
- Medical Device Global Market Access
COFEPRIS Approval: Your Strategy for the Mexican Dental Device Market
This episode explores the strategic pathway for bringing dental devices to the Mexican market. We delve into the regulatory framework managed by COFEPRIS, the…
- Medical Device Global Market Access
Navigating Mexico's IVD Market: COFEPRIS Compliance and the Distributor Gateway
This episode explores the strategic necessity for In-Vitro Diagnostic (IVD) manufacturers to partner with specialized, full-service distributors when entering…
- Medical Device Global Market Access
Mexico's IVD Market: Mastering COFEPRIS & Distributor Strategy
This episode explores the process of entering Mexico's In-Vitro Diagnostics (IVD) market. We examine the regulatory landscape managed by COFEPRIS, the critical…
- Medical Device Global Market Access
Mexico's IVD Market Expansion: A Distributor Strategy with PIDSA
This episode explores the pivotal role of local distributors in Mexico's burgeoning in-vitro diagnostics (IVD) market, using Proveedor Integral de Diagnóstico…
- Medical Device Global Market Access
Medical Imaging & Radiology in Mexico: The Medical Prado Case Study
This episode explores Mexico's medical device market through a profile of Medical Prado, a leading distributor for medical imaging and radiology equipment. We…