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PODCAST

LATAM MedTech Insights

Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.

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All Episodes

02:09

Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure...

LATAM MedTech Insights ·

2025/10/17

This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for any MedTech company looking to enter or expand its footprint in Latin America.We unpack what this harmonization means in practical terms. Consider this:

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02:02

Unlocking LATAM MedTech: How Pure Global Leverages...

LATAM MedTech Insights ·

2025/10/16

In this episode of LATAM MedTech Insights, we explore why a one-size-fits-all approach to entering the Latin American medical technology market is a recipe for failure. The region is not a monolith but a collection of unique countries, each with its own distinct regulatory, economic, and healthcare systems. Success depends on moving beyond surface-level data and leveraging deep market intelligence.We dissect how granular market briefs provide the critical insights needed to build a winning

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02:26

Pure Global's Deep Dive into Brazil: Mastering ANVISA...

LATAM MedTech Insights ·

2025/10/15

Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success.We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical

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02:04

Fast-Track Your LATAM Entry: Pure Global’s Guide to...

LATAM MedTech Insights ·

2025/10/14

In this episode of LATAM MedTech Insights, we dive deep into the unique regulatory landscape of Colombia, a pivotal market for any device manufacturer looking to enter Latin America. We uncover how INVIMA's dual-track system offers a strategic gateway for MedTech companies that know how to leverage it.We explore the powerful "automatic registration" pathway for low-risk devices that can get your product to market and generating revenue faster than you think. We also break down the complexities and

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02:17

Cracking Argentina's ANMAT: A MedTech Manufacturer's...

LATAM MedTech Insights ·

2025/10/13

In this episode of LATAM MedTech Insights, we demystify the complex process of medical device registration in Argentina. We provide a detailed guide on navigating the requirements of the national regulatory authority, ANMAT, from appointing a local registration holder to preparing a compliant technical dossier in Spanish. We break down the critical steps and common pitfalls that can lead to costly delays and rejections. Learn why your choice of a local partner can make or break your market access

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02:08

Pure Global's Guide to Peru: Navigating DIGEMID and...

LATAM MedTech Insights ·

2025/10/12

Peru's MedTech market offers immense growth opportunities, but entry is strictly controlled by its regulatory authority, DIGEMID. A critical step for any foreign manufacturer is appointing a local representative, known as a Peru Registration Holder. This isn't just a formality—it's a foundational strategic decision that dictates your control over your own products in the country. In this episode, we explore why the common shortcut of letting a distributor hold your product registration can lead to

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02:11

Pure Global's LATAM MedTech Insights: Unlocking a...

LATAM MedTech Insights ·

2025/10/11

This episode of LATAM MedTech Insights dives into one of the most stable and attractive regulatory environments in Latin America: Colombia. We explore how INVIMA, the national regulatory authority, offers a clear and predictable pathway for medical device manufacturers, standing in contrast to the complexities found elsewhere in the region.We specifically focus on the significant strategic advantage of Colombia's ten-year registration validity for most medical devices. This episode unpacks how

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02:13

Navigating Brazil's 2025 UDI Mandate: A Pure Global...

LATAM MedTech Insights ·

2025/10/10

Brazil, Latin America's largest MedTech market, is implementing a mandatory Unique Device Identification (UDI) system, with a critical deadline for high-risk devices looming in mid-2025. This change, mandated by ANVISA's RDC 591/2021, requires immediate action from manufacturers to ensure their products remain on the market. This episode of LATAM MedTech Insights breaks down the essential steps for preparing for Brazil's UDI rollout. We explore the unique challenge where device labeling is required

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02:30

Unlocking Brazil's MedTech Market: A Pure Global Deep...

LATAM MedTech Insights ·

2025/10/09

In this episode of LATAM MedTech Insights, we demystify the complex world of Brazil's medical device regulations under ANVISA. We explore the critical differences between the faster 'Notificação' pathway for low-risk devices and the intensive 'Registro' full-review process for high-risk products, revealing why your strategy for one won't work for the other.This episode is for any MedTech company that sees Brazil as a key market but is concerned about the regulatory hurdles. We break down the

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04:00

LATAM MedTech Insights by Pure Global: Unlocking the...

LATAM MedTech Insights ·

2025/10/08

In this episode of LATAM MedTech Insights, we explore the groundbreaking regulatory reforms in Mexico that are set to accelerate market access for medical device manufacturers. We break down the new COFEPRIS abbreviated pathway, which leverages approvals from other international regulatory bodies to streamline the registration process.This shift marks a significant opportunity for MedTech and IVD companies to enter one of Latin America's largest markets faster than ever before. We discuss the

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02:04

Pure Global's Guide to Mexico's MedTech Market: The...

LATAM MedTech Insights ·

2025/10/07

Mexico presents a golden opportunity for MedTech companies, but its regulatory body, COFEPRIS, has a critical requirement: all foreign manufacturers must appoint a local Mexico Registration Holder (MRH). This entity doesn't just submit your paperwork; they legally own your product registration, a detail that can make or break your business in the region. This episode of LATAM MedTech Insights dives deep into the strategic importance of this decision. We explore the significant risks of appointing

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03:09

Navigating LATAM MedTech Regulations for Surgical...

LATAM MedTech Insights ·

2025/10/06

In this episode of LATAM MedTech Insights, we dissect the complex regulatory pathways for two key medical device categories in Latin America: surgical instrument sets and electrosurgical units. We explore the fragmented nature of LATAM regulations, moving beyond generalities to offer specific, actionable insights. We delve into the critical "family grouping" strategies required by Brazil's ANVISA for large instrument sets and contrast them with the requirements of Mexico's COFEPRIS. For active

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03:27

LATAM MedTech Insights by Pure Global: Unlocking the...

LATAM MedTech Insights ·

2025/10/05

The Latin American market for anesthesia machines and equipment is expanding rapidly, driven by significant investments in both public and private healthcare infrastructure. This growth presents a massive opportunity for MedTech manufacturers, but it comes with a formidable challenge: a highly complex and fragmented regulatory environment that can stop even the most prepared companies in their tracks.In this episode, we unpack the practical realities of entering this lucrative market. We go beyond

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03:17

The LATAM Diabetes Tech Boom: Pure Global's Guide to...

LATAM MedTech Insights ·

2025/10/04

In this episode of LATAM MedTech Insights, we explore the immense opportunities and significant regulatory challenges of bringing blood glucose monitoring devices to the Latin American market. We uncover the specific demands of key regulatory bodies like Brazil's ANVISA, Mexico's COFEPRIS, and Argentina's ANMAT. We break down the complex, country-specific requirements that often trip up manufacturers. Imagine launching your state-of-the-art continuous glucose monitor in Brazil, only to be rejected

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03:09

The Goldmine and the Maze: Pure Global's Guide to...

LATAM MedTech Insights ·

2025/10/03

In this episode of LATAM MedTech Insights, we delve into the booming orthopedic surgical implant market across Latin America. We uncover why a successful market-entry strategy requires more than just a great product and existing international approvals. We explore the complex and fragmented regulatory landscapes of key countries like Brazil, Mexico, and Colombia, highlighting the critical differences that can make or break your expansion plans.We share a cautionary tale of a premier German knee

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03:12

Navigating LATAM's Heartbeat: A Pure Global Deep Dive...

LATAM MedTech Insights ·

2025/10/02

In this episode of LATAM MedTech Insights, we delve into the rapidly expanding but notoriously complex market for cardiac monitoring and ECG devices in Latin America. We uncover why the region's high demand, fueled by demographic shifts and a growing healthcare sector in countries like Brazil, Mexico, and Argentina, presents both a massive opportunity and a significant challenge for global MedTech manufacturers.We explore the fragmented regulatory maze, moving beyond theory to discuss the

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03:17

Pure Global LATAM MedTech Insights: Cracking the Code...

LATAM MedTech Insights ·

2025/10/01

In this episode of LATAM MedTech Insights, we delve into the burgeoning market for digital X-ray and radiographic equipment in Latin America. We explore the powerful growth drivers, from government healthcare modernization projects in Brazil to the booming private medical sector in Mexico, revealing why this region is a key target for global MedTech innovators.However, this opportunity is guarded by a maze of complex and fragmented regulations. We uncover the specific challenges of navigating

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02:27

Unlocking LATAM's Vision: Pure Global's Expert Guide...

LATAM MedTech Insights ·

2025/09/30

In this episode of LATAM MedTech Insights, we dissect the burgeoning market for endoscopic imaging systems in Latin America. We explore the massive opportunities in key countries and expose the intricate regulatory hurdles that often lead to costly delays and market access failures for international MedTech companies. We move beyond theory to discuss the practical realities of registering advanced medical devices in this high-growth region. From Brazil's demanding ANVISA documentation and INMETRO

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03:16

Unlocking LATAM's MedTech Potential: Pure Global's...

LATAM MedTech Insights ·

2025/09/29

In this episode of LATAM MedTech Insights, we explore the lucrative yet complex market for infusion pumps in Latin America. As hospitals across the region upgrade their technology for better patient outcomes, the demand for advanced medication delivery systems is at an all-time high. However, gaining market access is a formidable challenge, with each country's regulatory agency—from Brazil's ANVISA to Mexico's COFEPRIS—imposing unique and stringent requirements.We uncover the specific hurdles

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02:54

LATAM's New Breath: Navigating Brazil's Ventilator...

LATAM MedTech Insights ·

2025/09/28

In this episode of LATAM MedTech Insights, we move beyond the headlines of the pandemic to uncover the real state of the respiratory device market in Latin America. The urgent rush for ventilators has subsided, leaving behind a complex landscape of equipment surplus, shifting clinical needs, and formidable regulatory barriers. We explore how the focus is moving from emergency ICU equipment to long-term solutions for chronic conditions like COPD and sleep apnea, creating new opportunities for agile

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