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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

03:40

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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02:40

Vietnam's MedTech Gatekeeper: The Crucial Role of the...

Medical Device Global Market Access ·

2025/10/17

This episode provides a detailed overview of the mandatory Registration Number Holder (Tổ chức đứng tên đăng ký) in Vietnam for foreign medical device manufacturers. We explore the critical legal, post-market, and commercial responsibilities assigned to this local entity under the governing regulation, Decree 98/2021/ND-CP, which came into effect on January 1, 2022. Key obligations discussed include post-market surveillance, adverse event reporting, product recalls, price declaration, advertising

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03:01

Singapore's MedTech Gatekeeper: The Crucial Role of...

Medical Device Global Market Access ·

2025/10/16

This episode demystifies the single most critical requirement for medical device manufacturers entering the Singaporean market: the local Registrant. We explore the legal framework established by the Health Products Act of 2007, defining the Registrant's non-negotiable role as the in-country representative responsible for product registration, post-market surveillance, and all communication with the Health Sciences Authority (HSA). Listeners will learn about the Registrant's key responsibilities and

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03:06

India's Medical Device Market: Your Guide to the...

Medical Device Global Market Access ·

2025/10/15

This episode breaks down the essential role of the Authorized Indian Agent (AIA) for medical device companies entering the Indian market. We explore the regulatory framework under the CDSCO, the specifics of the MD-14 and MD-15 forms, and the critical strategic considerations when appointing your in-country representative.• What is an Authorized Indian Agent (AIA) and why is it mandatory in India? • How do Forms MD-14 and MD-15 govern the medical device import license process? • What are the key

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03:04

China's NMPA Gatekeeper: The In-China Domestic Agent...

Medical Device Global Market Access ·

2025/10/14

This episode demystifies the mandatory role of the In-China Domestic Agent for foreign medical device manufacturers entering the Chinese market. We explore the legal basis under State Council Order 739, effective June 1, 2021, and detail the agent's critical responsibilities in registration, NMPA communication, post-market surveillance, adverse event reporting, and recall management. Learn why selecting the right agent is a vital strategic decision for ensuring long-term regulatory compliance in

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03:07

Unlocking the Japanese MedTech Market: The DMAH Strategy

Medical Device Global Market Access ·

2025/10/13

This episode demystifies the role of the Designated Marketing Authorization Holder (DMAH) for medical device companies entering Japan. We explore the critical differences between an MAH and a DMAH, outlining how the DMAH model allows foreign manufacturers to retain full ownership and control of their product approvals. Listeners will learn about the key responsibilities of a DMAH under the PMD Act, from regulatory submissions to post-market surveillance, and understand the strategic advantages of

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03:01

The Australian Gatekeeper: Choosing Your TGA Medical...

Medical Device Global Market Access ·

2025/10/12

This episode delves into the essential role of the Australian Sponsor for medical device companies seeking to enter the Australian market. We explain the legal requirements set by the Therapeutic Goods Administration (TGA), the critical responsibilities of a sponsor, and analyze the significant strategic differences between appointing a distributor versus an independent third-party sponsor. Understand how this key decision impacts your regulatory approvals, market flexibility, and long-term success

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02:56

New Zealand MedTech: The Crucial Role of the Local...

Medical Device Global Market Access ·

2025/10/11

This episode demystifies the process of entering the New Zealand medical device market by focusing on the critical role of the New Zealand Sponsor, a mandatory requirement for all overseas manufacturers. We break down the sponsor's responsibilities as mandated by Medsafe, from the initial notification in the WAND database to the crucial ongoing duties of post-market surveillance and vigilance. This discussion highlights why the sponsor is more than just a local contact—they are your legal

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03:23

Canada's MedTech Entry Pass: MDL vs. MDEL Explained

Medical Device Global Market Access ·

2025/10/10

This episode demystifies Canada's dual-licensing system for medical devices. We clarify the critical differences between a product-specific Medical Device Licence (MDL) for Class II-IV devices and a company-specific Medical Device Establishment Licence (MDEL) required for Class I manufacturers, importers, and distributors. Learn who needs which license, the role of the importer, and why the concept of a regulatory correspondent is vital, even without a formal in-country representative

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03:13

Unlocking Switzerland: Your Guide to the Swiss...

Medical Device Global Market Access ·

2025/10/09

This episode unpacks the essential requirements for placing medical devices on the Swiss market following the lapse of the EU-Switzerland Mutual Recognition Agreement. We explore the role and legal responsibilities of the mandatory Swiss Authorised Representative (CH REP), detail the past compliance deadlines for all device and IVD classes, and explain critical labeling and registration requirements with the Swiss authority, Swissmedic.Key Questions • Why is Switzerland now considered a 'third

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311 results

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