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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

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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03:00

Regain Control: Switching Your Medical Device...

Medical Device Global Market Access ·

2025/11/04

This episode explores the critical risks of allowing a distributor to hold your medical device registration in Peru and outlines the strategic advantages of using an independent Peru Registration Holder (PRH). We discuss how this decision impacts your market control, business flexibility, and long-term security. Learn about the process of transferring registration ownership with DIGEMID and why separating your regulatory representation from your commercial partnerships is essential for success.•

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03:12

Mexico MedTech: Untangling Your COFEPRIS Registration...

Medical Device Global Market Access ·

2025/11/03

This episode explores the critical process of transferring a medical device registration holder in Mexico. We uncover the risks of appointing a distributor as your legal representative with COFEPRIS and detail the complex legal steps required for a transfer of rights. Learn why choosing an independent registration holder from the outset is the key to maintaining control over your market access and commercial flexibility in this major Latin American market. Key Questions: • What is a Mexico

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03:13

Regain Control: Switching Your INVIMA Holder in Colombia

Medical Device Global Market Access ·

2025/11/02

This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business risks of allowing a distributor to be the registration holder and outline the strategic advantages of using an independent third party. Learn about the process for transferring ownership, the potential pitfalls of an uncooperative distributor, and how to maintain full control over your commercial strategy in this key Latin American market. • What is an

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02:52

Brazil's MedTech Market: Escaping the Distributor Trap

Medical Device Global Market Access ·

2025/11/01

This episode delves into a crucial aspect of the Brazilian medical device market: the role of the Brazil Registration Holder (BRH). We explore the significant differences and long-term consequences of appointing a distributor versus an independent third party to hold your device registration with ANVISA. Learn how to avoid common pitfalls that can limit your commercial flexibility and gain control over your market strategy.• What is a Brazil Registration Holder (BRH) and why is it mandatory? •

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03:23

UAE Regulatory Update: Gaining Control with an...

Medical Device Global Market Access ·

2025/10/31

This episode explores the pivotal regulatory change in the United Arab Emirates allowing medical device manufacturers to appoint an independent Local Authorized Representative (LAR), decoupling registration from commercial distribution. We analyze the risks of the old distributor-as-LAR model and highlight the strategic advantages of the new system, including enhanced market flexibility, greater control over registrations, and improved business continuity for MedTech companies targeting the UAE.•

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03:40

SFDA Success: Regain Control by Switching Your Saudi...

Medical Device Global Market Access ·

2025/10/30

This episode explores the critical strategic decision for medical device manufacturers in Saudi Arabia: moving from a distributor-based Local Authorized Representative (LAR) to an independent one. We delve into the significant risks of tying your SFDA product registrations to a commercial partner and outline the clear benefits and straightforward process for making the switch. Learn how to take control of your market access, enhance your strategic flexibility, and secure your business in the

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03:24

Turkey's New Medical Device Rule: Why Your...

Medical Device Global Market Access ·

2025/10/30

This episode unpacks a crucial change in Turkey's medical device regulations following its alignment with the EU MDR on June 2, 2021. We explore why foreign manufacturers can no longer use their commercial distributors as their Turkish Authorized Representative (TR-REP). The discussion focuses on the inherent conflict of interest between sales and regulatory compliance, the legal responsibilities of an independent TR-REP, and the necessary steps manufacturers must take to appoint a new

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04:07

Switzerland's CH-REP Rule: Is Your Distributor a...

Medical Device Global Market Access ·

2025/10/29

This episode delves into the critical role of the Swiss Authorized Representative (CH-REP) for medical device manufacturers. We explore the significant regulatory changes that made the CH-REP mandatory and uncover the hidden risks of appointing a commercial distributor for this function. Learn why an independent CH-REP is the more strategic choice for ensuring long-term compliance and commercial flexibility in the Swiss market.• Why did Switzerland become a regulatory "third country" for medical

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212 results

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