Podcast Episodes

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Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)
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 mandator…

9 months, 1 week ago

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EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European 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 e…

9 months, 1 week ago

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Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico
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 regulato…

9 months, 1 week ago

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Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval
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 nat…

9 months, 1 week ago

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COFEPRIS Approval: Your Strategy for the Mexican Dental Device Market
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 COFE…

9 months, 2 weeks ago

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Navigating Mexico's IVD Market: COFEPRIS Compliance and the Distributor Gateway
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…

9 months, 2 weeks ago

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Mexico's IVD Market: Mastering COFEPRIS & Distributor Strategy
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, th…

9 months, 2 weeks ago

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Mexico's IVD Market Expansion: A Distributor Strategy with PIDSA
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 Di…

9 months, 2 weeks ago

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Medical Imaging & Radiology in Mexico: The Medical Prado Case Study
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 equi…

9 months, 2 weeks ago

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Partnering for Success: Navigating Mexico's Medical Imaging Sector
Partnering for Success: Navigating Mexico's Medical Imaging Sector

This episode explores the strategic advantages of partnering with specialized local distributors to enter Mexico's medical imaging and radiology mark…

9 months, 2 weeks ago

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