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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

02:40

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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03:15

Beyond the Mailbox: Your EU Rep's Critical MDR & IVDR...

Medical Device Global Market Access ·

2025/10/08

This episode delves into the critical role of the European Authorised Representative (EC REP) for non-EU medical device and IVD manufacturers under the MDR and IVDR. We explore how the responsibilities have expanded beyond a simple administrative function to include significant legal liability and active compliance verification, making the choice of your EC REP a crucial strategic decision for successful market access.• What is a European Authorised Representative (EC REP)? • Why is appointing an

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03:13

Post-Brexit MedTech Compliance: The Crucial Role of...

Medical Device Global Market Access ·

2025/10/07

This episode breaks down the essential post-Brexit requirement for non-UK medical device manufacturers: the UK Responsible Person (UKRP). We explore the legal obligations, key responsibilities in relation to the MHRA, and the critical role the UKRP plays in registering devices, maintaining technical documentation, and facilitating post-market surveillance for access to the market in Great Britain. Key Questions: • What is a UK Responsible Person (UKRP) and why is it mandatory? • Which manufacturers

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03:19

Brazil's Regulatory Gatekeeper: Navigating the Brazil...

Medical Device Global Market Access ·

2025/10/06

This episode provides a comprehensive guide to the Brazil Registration Holder (BRH), a mandatory requirement for foreign medical device manufacturers seeking market access in Brazil. We explore the critical role the BRH plays as the legal holder of the ANVISA registration, detailing their extensive responsibilities from initial submission to post-market surveillance. The discussion emphasizes the strategic importance of choosing between a distributor and an independent third-party representative,

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02:58

FDA's Gatekeeper: A Guide to the U.S. Agent for...

Medical Device Global Market Access ·

2025/10/05

This episode breaks down the mandatory FDA requirement for foreign medical device manufacturers to appoint a U.S. Agent. We explore the specific roles, responsibilities, and qualifications of a U.S. Agent, clarifying their function as the essential communication link between your company and the FDA. Learn the key differences between a U.S. Agent and an Official Correspondent and understand the strategic considerations when choosing your representative to ensure smooth entry into the U.S.

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02:39

The MedTech Partnership Playbook: A Blueprint for...

Medical Device Global Market Access ·

2025/10/04

This episode outlines a strategic framework for building powerful and mutually beneficial partnerships in the MedTech industry. We explore how to create a central hub for collaborators and tailor your value proposition to different partner types—from venture capitalists to distributors—all while adhering to core principles like transparency and long-term value.• How can you create a clear and effective partnership strategy? • What is the key to attracting the right type of partners for your

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02:55

Expand Your Catalog: A Distributor's Guide to...

Medical Device Global Market Access ·

2025/10/03

This episode provides a roadmap for medical device distributors and resellers looking to add a profitable, in-demand solution to their catalog. We explore the massive growth in the global medical device market, forecast for 2024 and beyond, and break down the key elements of a successful manufacturer-distributor partnership. Learn about the value proposition, from attractive margins to products that practically sell themselves, and discover the essential support systems, including sales training, a

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02:31

Supercharge Your MedTech Consultancy: Drive Client...

Medical Device Global Market Access ·

2025/10/02

In this episode, we explore a powerful partnership model for MedTech consulting firms. Discover how collaborating with Pure Global can enhance your service offerings, help you deliver tangible, data-driven results for your clients, and unlock new revenue streams for your business. We detail the dedicated support, co-marketing opportunities, and sales collateral available to our partners, positioning you to drive unmatched client success in the complex world of global market access.Key Questions: •

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02:48

De-Risking MedTech Investments: A VC's Guide to...

Medical Device Global Market Access ·

2025/10/01

This episode is dedicated to venture capital firms invested in the medical device sector. We explore how a strategic regulatory partnership is not just an operational service but a critical tool for de-risking investments and accelerating the growth of portfolio companies. We discuss the tangible benefits of early regulatory planning, including faster market entry, enhanced capital efficiency, and a significant competitive advantage, ultimately amplifying the value of your MedTech portfolio.• How

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03:28

Regulatory Red Flags: Fixing Common Submission Gaps...

Medical Device Global Market Access ·

2025/09/30

This episode unpacks the most common and costly documentation mistakes that medical device manufacturers make in their regulatory submissions. We explore specific gaps frequently flagged by Notified Bodies and the FDA, focusing on the Clinical Evaluation Report (CER), risk management files, and Post-Market Clinical Follow-up (PMCF) plans. Learn how to identify these deficiencies in your own technical files and, more importantly, how to fix them quickly to avoid delays and ensure a smoother path to

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03:51

Your Blueprint for Global MedTech Compliance

Medical Device Global Market Access ·

2025/09/29

Choosing the right international standards is a critical strategic decision for any medical device manufacturer. This episode provides a clear framework for navigating the complex world of MedTech standards, starting with the foundational requirements for quality management (ISO 13485), risk management (ISO 14971), and software (IEC 62304). We explore how to build upon this core to select device-specific standards that ensure safety, efficacy, and smoother regulatory submissions worldwide, including

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04:03

Is Your MedTech Firm Ready for Europe? Avoiding...

Medical Device Global Market Access ·

2025/09/28

This episode delves into the most common and costly mistakes medical technology companies make when seeking EU MDR compliance. We break down the complexities of technical documentation, clinical evidence requirements, risk management, and post-market surveillance, offering actionable strategies to avoid these pitfalls, streamline your submission process, and prevent significant delays and rejections from Notified Bodies.Key Questions: • Is your technical documentation truly 'reviewer-ready'? • Are

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260 results

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