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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

03:00

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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03:24

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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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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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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03:26

EU Medical Devices: Breaking Up with Your...

Medical Device Global Market Access ·

2025/10/28

This episode explores the critical shift for medical device manufacturers from using a distributor as their EU Authorized Representative (EC-REP) to appointing a professional, independent representative in France. We delve into the increased liabilities under the MDR, the inherent conflicts of interest in the distributor model, and the significant commercial and regulatory advantages of partnering with an independent AR for streamlined access to the French and broader EU markets.• Why is using a

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03:40

Switching Your German EC-REP: From Distributor to...

Medical Device Global Market Access ·

2025/10/27

This episode details the strategic process for medical device manufacturers to transition from a distributor-based EU Authorized Representative (EC-REP) to an independent one in Germany. We cover the regulatory requirements under MDR Article 12, the importance of the tripartite agreement, and the necessary steps for a smooth handover, including German database updates and labeling changes. • Why is using a distributor as an EC-REP a potential conflict of interest? • What is the first step in

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03:28

Distributor as UKRP: The Hidden Risk to Your UK...

Medical Device Global Market Access ·

2025/10/26

Since Brexit, non-UK medical device manufacturers need a UK Responsible Person (UKRP) to access the Great Britain market. While appointing a local distributor for this role is a common shortcut, it creates a significant conflict of interest between sales and regulatory compliance. This episode explores the hidden risks of this approach—from a lack of regulatory expertise to giving a commercial partner leverage over your market access—and makes the case for appointing a specialized, independent UKRP

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03:44

Spain MedTech Compliance: Ditching Your Distributor...

Medical Device Global Market Access ·

2025/10/25

This episode explores the critical need for non-EU medical device manufacturers to replace their distributor-based EU Authorized Representative (EC-REP) with an independent one, particularly for the Spanish market. We delve into the increased liabilities for EC-REPs under the EU MDR (Regulation (EU) 2017/745), the inherent conflicts of interest when a distributor holds this role, and the clear benefits of partnering with a neutral, compliance-focused representative. Learn the official step-by-step

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03:45

Unlocking Italy: The Distributor vs. Independent EU...

Medical Device Global Market Access ·

2025/10/24

This episode explores the critical shift for MedTech manufacturers from using distributors to appointing independent Authorized Representatives (EC-REPs) in Italy, driven by the EU's Medical Device Regulation (MDR). We unpack the increased legal liabilities, conflicts of interest, and commercial risks associated with the old model, and explain why an independent AR is now essential for secure and flexible market access.Key Questions: • Why is using your Italian distributor as your EU Authorized

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02:34

Indonesia's MedTech Gatekeeper: Choosing Your Local...

Medical Device Global Market Access ·

2025/10/23

This episode delves into the crucial role of the Pemegang Izin Edar, or Local Authorized Representative, for medical device market access in Indonesia. We explore the regulatory requirements mandated by the Ministry of Health, the responsibilities of the license holder, and the critical strategic differences between appointing a distributor versus an independent third party to hold your product registration. Understanding this choice is fundamental to maintaining control and flexibility in this key

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05:29

Unlocking the UAE MedTech Market: The Crucial Role of...

Medical Device Global Market Access ·

2025/10/22

This episode delves into the essential requirement for medical device manufacturers to appoint a Marketing Authorization Holder (MAH) or Local Authorized Representative to enter the United Arab Emirates market. We explore the role and responsibilities of this local partner as mandated by the Ministry of Health and Prevention (MOHAP), the strategic implications of choosing a distributor versus an independent representative, and the key functions they perform in device registration and post-market

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03:03

Navigating the SFDA: Your Guide to Saudi Authorized...

Medical Device Global Market Access ·

2025/10/22

This episode provides a detailed overview of the mandatory requirement for medical device manufacturers to appoint a Saudi Authorized Representative (AR) to enter the market in Saudi Arabia. We explore the key responsibilities of the AR, from regulatory submissions with the Saudi Food and Drug Authority (SFDA) to post-market surveillance, and analyze the strategic advantages of appointing an independent AR over a commercial distributor.Key Questions • What is a Saudi Authorized Representative and

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02:44

Philippine Medical Device Registration: Why Your MAH...

Medical Device Global Market Access ·

2025/10/21

This episode delves into the essential role of the Marketing Authorization Holder (MAH) for medical device registration in the Philippines. We explore the regulatory requirements set by the Philippine FDA, the responsibilities of an MAH, and the critical strategic considerations for foreign manufacturers when selecting a local representative. Understanding the distinction between a distributor-as-MAH and an independent MAH is key to maintaining control over your market access and long-term business

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02:57

Israel's Gatekeeper: Mastering the Role of the IRH...

Medical Device Global Market Access ·

2025/10/20

Navigating the Israeli medical device market requires a deep understanding of its unique regulatory landscape. This episode provides a comprehensive overview of the Israel Registration Holder (IRH), a mandatory in-country representative for foreign manufacturers. We explore the IRH's crucial role in liaising with the AMAR (Ministry of Health), their extensive responsibilities from registration to post-market surveillance, and the strategic advantages of appointing an independent holder over a

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03:13

Thailand's MedTech Gatekeeper: Navigating the Local...

Medical Device Global Market Access ·

2025/10/19

This episode delves into the essential role of the License Holder (ผู้รับใบอนุญาต) for foreign medical device manufacturers entering the Thai market. We explain why appointing a local representative is mandatory under the Medical Devices Act, detailing their key responsibilities which include obtaining an Establishment License, managing product registration with the Thai FDA, and overseeing all post-market surveillance and vigilance activities. We also analyze the critical strategic decision between

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03:40

Malaysia MedTech: Your Guide to Authorized...

Medical Device Global Market Access ·

2025/10/18

This episode delves into the essential roles of the Authorized Representative (AR) and Registrant for medical device market access in Malaysia. We clarify the legal requirements under the Medical Device Act 2012 (Act 737), explain the responsibilities of a Malaysian AR, and break down the critical strategic differences between appointing a distributor versus an independent third-party as your representative. Understanding this distinction is key to maintaining control over your device registration

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260 results

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