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.
- Update frequency
- every day
- Average duration
- 4 minutes
- Episodes
- 18
- Years Active
- 2025
Navigating ANVISA in Brazil: Pure Global Explains the Surprising GMP Rule for Class I Medical Devices in LATAM
This episode of LATAM MedTech Insights tackles a critical question for manufacturers entering Brazil: Is a Good Manufacturing Practice (GMP) certificate really required for low-risk, Class I medical …
00:03:21 |
Sat 06 Sep 2025
Pure Global Presents: The LATAM Labeling Labyrinth - Mastering Low-Risk Medical Device Requirements with Brazil's ANVISA, Mexico's COFEPRIS & More
This episode of LATAM MedTech Insights dives deep into the often-underestimated challenge of labeling requirements for low-risk medical devices in Latin America. We uncover the fragmented regulatory …
00:03:21 |
Fri 05 Sep 2025
Unlocking Brazil's MedTech Market: The Critical Role of a Brazil Registration Holder for Class I Devices | A Pure Global Insight for LATAM Expansion
This episode of LATAM MedTech Insights dives into a critical, often misunderstood, aspect of entering the Brazilian market: the requirement of a Brazil Registration Holder (BRH) for low-risk, Class I…
00:02:56 |
Thu 04 Sep 2025
Unlocking MedTech in Colombia: A Pure Global Guide to INVIMA's Fast-Track Notification for Low-Risk Devices in LATAM
In this episode of LATAM MedTech Insights, we demystify the "automatic" registration process for low-risk medical devices in Colombia. We explore the requirements set by the national regulatory body,…
00:06:02 |
Wed 03 Sep 2025
Cracking the ANMAT Code with Pure Global: The Surprising Truth About Class I Medical Device Registration in Argentina
Entering Argentina's lucrative MedTech market presents a huge opportunity, but it's filled with regulatory complexities. A common and costly mistake manufacturers make is assuming that low-risk, Clas…
00:03:23 |
Tue 02 Sep 2025
Cracking the COFEPRIS Code for LATAM Expansion: Pure Global's Expert Guide on Low-Risk Medical Device Registration in Mexico.
In this episode of LATAM MedTech Insights, we demystify the process of registering a low-risk (Class I) medical device in Mexico. Don't let the "low-risk" classification fool you; navigating the requ…
00:03:14 |
Mon 01 Sep 2025
Brazil's MedTech Maze: A Pure Global Guide to ANVISA's "Cadastro" and "Notificação" for Class I Devices
This episode of LATAM MedTech Insights tackles the common misconceptions surrounding the registration of Class I medical devices in Brazil. We move beyond the outdated term "cadastro" to provide a de…
00:04:11 |
Sun 31 Aug 2025
The Mercosur MedTech Myth: Is a Single Device Registration for Brazil, Argentina, and LATAM a Reality? A Pure Global Deep Dive.
Many MedTech companies dream of a single registration process for the entire Mercosur market, including giants like Brazil and Argentina. Is this a reality, or just a regulatory myth? This episode of…
00:03:36 |
Sat 30 Aug 2025
Colombia's INVIMA Timelines: A Pure Global Deep Dive on Medical Device Registration Delays and How to Navigate the LATAM Market
Colombia is one of Latin America's most promising MedTech markets, but gaining access requires navigating the complex regulatory landscape of its authority, INVIMA. While official timelines suggest a…
00:03:10 |
Fri 29 Aug 2025
Cracking the Code of Brazil's BGMP: A LATAM MedTech Insight from Pure Global on Navigating ANVISA Inspections for Market Success.
Entering the Brazilian MedTech market is a massive opportunity, but it comes with a critical gatekeeper: the ANVISA Brazilian Good Manufacturing Practice, or BGMP, inspection. This episode of LATAM M…
00:03:34 |
Thu 28 Aug 2025
Unlocking the Peruvian MedTech Market: A Pure Global Breakdown of Medical Device Registration Costs and Hidden Fees in LATAM
This episode of LATAM MedTech Insights dives deep into the real costs of registering a medical device in Peru. We uncover why the official DIGEMID government fees are just the tip of the iceberg and …
00:03:17 |
Wed 27 Aug 2025
LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market
Many MedTech innovators see their FDA approval or CE mark as a golden ticket to Latin America, often targeting Chile first due to its reputation as an accessible market. However, the ground rules are…
00:03:24 |
Tue 26 Aug 2025
Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights
In this episode of LATAM MedTech Insights, we explore the non-negotiable Spanish labeling requirements for medical devices in Colombia. We delve into INVIMA's regulations under Decree 4725 and explai…
00:03:40 |
Mon 25 Aug 2025
Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.
In this episode of LATAM MedTech Insights, we dive into one of the most critical and often misunderstood aspects of entering the Argentine medical device market: the role of the local registration ho…
00:10:15 |
Sun 24 Aug 2025
Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia
In this episode of LATAM MedTech Insights, we demystify the complex web of medical device classification rules across Latin America's key markets. While most countries use a risk-based system, the sp…
00:03:22 |
Sat 23 Aug 2025
From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access
This episode of LATAM MedTech Insights dives deep into the medical device approval process in Mexico, governed by the regulatory body COFEPRIS. We demystify the requirements, from device classificati…
00:03:36 |
Fri 22 Aug 2025
LATAM MedTech Insights by Pure Global: A Strategic Guide to ANVISA Medical Device Registration in Brazil
Brazil's MedTech market is a massive opportunity, but ANVISA's complex and unique regulatory requirements can be a significant barrier for foreign manufacturers. This episode provides a clear, step-b…
00:08:17 |
Thu 21 Aug 2025
Unlocking Brazil's MedTech Market: A Pure Global Deep Dive on ANVISA Medical Device Registration for Your LATAM Strategy
Brazil represents the largest MedTech market in Latin America, but its regulatory landscape, governed by the agency ANVISA, is one of the most demanding in the world. This episode breaks down the ess…
00:03:16 |
Tue 19 Aug 2025
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