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PODCAST

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

technology

All Episodes

02:50

AI in MedTech Regulatory Affairs: Scaling to 30+...

Medical Device Global Market Access ·

2025/11/24

This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling broader global market access. We discuss the shift from costly, manual submissions to an efficient, technology-driven model that allows MedTech companies of all sizes to bring life-saving innovations to patients worldwide. Learn how AI is not just a tool for efficiency but a force for democratizing global healthcare access. Key Questions: - How

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02:51

Free AI Agents: The Future of Medical Device...

Medical Device Global Market Access ·

2025/11/23

This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and global device databases accessible at no cost is breaking down financial barriers, enabling MedTech companies to expand their reach into new international markets more efficiently and affordably. This shift promises to accelerate the availability of life-saving technologies to patients around the world.- How is Artificial Intelligence

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03:16

Colombia Medical Device Registration: Unpacking...

Medical Device Global Market Access ·

2025/11/22

This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian market. Key Questions - What is Decree 4725 and why is it essential for market access in Colombia? - How does INVIMA classify medical devices based on

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03:12

Mexico's Technovigilance: Mastering COFEPRIS NOM-240...

Medical Device Global Market Access ·

2025/11/21

This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration renewal. We also discuss the significant updates proposed in the draft 2024 version of the standard, which will impact software devices and distributor

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03:07

Mexico's New Medical Device Labeling Standard: A Deep...

Medical Device Global Market Access ·

2025/11/20

This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbols and date formats. We cover the official publication and effective dates, helping manufacturers understand the timeline for compliance to maintain

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03:15

Navigating NOM-241-SSA1-2021: Medical Device GMP...

Medical Device Global Market Access ·

2025/11/19

This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key requirements for medical device manufacturers, including the implementation of a Quality Management System, risk management protocols, and alignment with ISO 13485. We discuss the standard's scope, its effective date, and the practical implications for companies seeking to enter or remain compliant in the Mexican market.Key Questions - What is

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03:24

Navigating COFEPRIS: A Deep Dive into Mexico's...

Medical Device Global Market Access ·

2025/11/18

This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of the regulatory authority, COFEPRIS, the risk-based device classification system, and the available registration pathways, including the Standard and Equivalency routes. The host also covers the crucial updates from the 5th edition of the Mexican Pharmacopoeia's supplement, which became effective in July 2023. - What is the primary regulation

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02:54

Mexico's COFEPRIS Framework: A Deep Dive into the Ley...

Medical Device Global Market Access ·

2025/11/17

This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market access. We explore the role and authority of the regulatory body, COFEPRIS, and break down the key requirements manufacturers must meet, from pre-market registration and GMP compliance to post-market technovigilance and import controls. Key Questions - What is the Ley General de Salud and why is it critical for MedTech companies? - How does

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03:16

Brazil GMP Certification: A Deep Dive into RDC...

Medical Device Global Market Access ·

2025/11/16

This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) certification for Class III and IV medical device manufacturers. We explore the key requirements, audit procedures, and documentation needed to secure the mandatory CBPF certificate, highlighting the changes from the previous RDC 183/2017 and what international manufacturers must do to successfully enter the Brazilian market for high-risk devices.Key

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03:13

Navigating Brazil's ANVISA Technovigilance: A Deep...

Medical Device Global Market Access ·

2025/11/15

This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore the mandatory requirements for post-market surveillance, the critical role of the Brazilian Registration Holder (BRH), and the specific, strict timelines set by ANVISA for reporting adverse events, malfunctions, and field safety corrective actions to ensure continued compliance and patient safety in the Brazilian market. - What is the primary purpose of

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03:07

Brazil's BGMP Overhaul: Navigating ANVISA RDC...

Medical Device Global Market Access ·

2025/11/14

This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufacturing Practices (BGMP) requirements, its alignment with international standards like ISO 13485, its replacement of the former RDC 16/2013, and its crucial integration with the Medical Device Single Audit Program (MDSAP) for streamlining market entry.Key Questions: - What is ANVISA RDC 665/2022 and who does it apply to? - How does this resolution

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03:10

Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New...

Medical Device Global Market Access ·

2025/11/13

This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the critical changes to risk classification systems, which align with international standards and result in the up-classification of many devices. The discussion covers the impact on regulatory pathways, technical documentation, and labeling, offering essential insights for manufacturers to ensure continued market access in Brazil.- What is Brazil's new RDC

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03:36

ANVISA RDC 751/2022: A Manufacturer's Guide to...

Medical Device Global Market Access ·

2025/11/12

This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore its comprehensive framework, including the four-tier risk classification system, the distinct pathways for notification and registration, and its alignment with international standards like the IMDRF Table of Contents. The host also discusses modernized rules for Software as a Medical Device (SaMD) and what these significant changes mean for

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03:44

Singapore MedTech: How to Break Free from Distributor...

Medical Device Global Market Access ·

2025/11/11

This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning from a distributor-held registration to an independent registrant. We explain why tying your regulatory license to a commercial partner creates business risks and outline the strategic advantages and procedural steps involved in making the switch with Singapore's Health Sciences Authority (HSA).Key Questions: • What is an HSA Registrant and why is it

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02:51

Unlocking Your MedTech in Vietnam: The Registration...

Medical Device Global Market Access ·

2025/11/10

This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direct license transfer between holders is not permitted by the Ministry of Health. Instead, manufacturers must navigate a full re-registration process. We outline the steps involved and highlight the significant strategic advantages of appointing an independent registration holder to maintain control and flexibility over your market access. Key

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03:09

Japan's D-MAH System: Regaining Control of Your...

Medical Device Global Market Access ·

2025/11/09

This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder (D-MAH) for medical device registration in Japan. We break down how using an independent D-MAH allows foreign manufacturers to retain ownership of their marketing approvals, providing essential flexibility in distribution strategy, safeguarding confidential information, and ensuring robust regulatory compliance in the Japanese market.Key Questions: •

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02:43

Australia TGA Sponsor: How to Take Control of Your...

Medical Device Global Market Access ·

2025/11/08

This episode delves into the strategic process of changing a TGA Sponsor for medical devices in Australia. We explore the critical differences between using a distributor as a sponsor versus an independent sponsor, outlining the risks of the former and the long-term benefits of the latter. Learn about the official transfer process, the importance of Manufacturer Evidence, and the key steps to ensure a smooth transition while maintaining market access and regulatory control. Key Questions: • What is

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03:23

Unlocking India: The Strategic Advantage of an...

Medical Device Global Market Access ·

2025/11/07

This episode explores the critical process of switching your Indian Authorized Agent (IAA) with the CDSCO, moving from a commercially-tied distributor to an independent regulatory partner. We detail the significant business risks of using a distributor as your agent and provide a step-by-step guide for making the change, including the crucial role of the No-Objection Certificate (NOC). Learn how an independent IAA provides commercial flexibility and secures your long-term market access in

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03:06

Regain Control: Transferring Your ANMAT Registration...

Medical Device Global Market Access ·

2025/11/06

This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent holder. We explore the strategic risks of distributor-held registrations, such as commercial lock-in, and provide a clear overview of the transfer process, including the role of the Argentina Authorized Representative (AAR) and the importance of the governing regulation, ANMAT Provision 9688 of 2019. Listeners will learn the necessary steps and key

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03:02

Unlock Chile: Why Your Distributor Shouldn't Own Your...

Medical Device Global Market Access ·

2025/11/05

This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration holder. We detail the significant risks of appointing a distributor as your registration holder with the Instituto de Salud Pública (ISP), including loss of market control and conflicts of interest. The discussion then shifts to the strategic advantages of using an independent, third-party representative, which ensures manufacturers retain full ownership

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260 results

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