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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

Securing Your Assay's CPT Code: A Guide to US...

Medical Device Global Market Access ·

2025/09/12

This episode details the process of obtaining a unique CPT or PLA code for a diagnostic assay in the U.S. and its direct impact on reimbursement under the Medicare Clinical Laboratory Fee Schedule (CLFS). We cover the application steps with the American Medical Association (AMA), the role of the PAMA Act, and recent legislative updates affecting payment rates and reporting deadlines.• What is a Proprietary Laboratory Analyses (PLA) code and why is it crucial for my new assay? • What is the

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03:15

FDA Export Certificates: Navigating Apostille and...

Medical Device Global Market Access ·

2025/09/11

This episode demystifies the critical process of authenticating FDA export documents, such as the Certificate to Foreign Government (FSC/CFG), for international markets. We explore the difference between an apostille and full legalization, explain why foreign regulators require this step, and detail the impact of the FDA's transition to electronic certificates as of January 2, 2024. Learn the new rules and procedures to ensure your medical device shipments aren't delayed at the border.Key

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03:26

Unlocking Exports: FSC Documentation by Device Class

Medical Device Global Market Access ·

2025/09/10

This episode provides a detailed guide on the essential supporting documents required for a Free Sales Certificate (FSC) application. We break down the specific requirements based on medical device classification under the EU MDR, clarifying which documents, such as the Declaration of Conformity, ISO 13485, and CE certificates, are necessary for Class I, IIa, IIb, and III devices. Understand the critical differences in documentation to ensure your export applications are successful.Key

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03:38

Your Product's Passport: Unlocking Global Sales with...

Medical Device Global Market Access ·

2025/09/09

In this episode, we demystify the Free Sales Certificate (FSC), a critical document for medical device and IVD manufacturers aiming for international expansion. We explore what an FSC is, why it's a mandatory requirement for registration in many countries across Asia, Latin America, and the Middle East, and how it serves as proof of regulatory compliance in your home market. The host explains who issues these certificates in key regions like the EU and the US, and discusses recent changes under the

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02:55

Navigating FDA Export Certificates: Timelines, Fees,...

Medical Device Global Market Access ·

2025/09/08

This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US FDA. We cover the official timelines for issuance, the specific government fees you can expect to pay, and the critical procedural shift to electronic-only certificates that took effect in early 2024. Learn the essential details to plan your international market submissions effectively and avoid costly delays. • What is the official FDA term for a

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03:20

Certificate of Free Sale: Who Is Eligible to Apply?

Medical Device Global Market Access ·

2025/09/08

This episode clarifies the complex eligibility requirements for obtaining a Certificate of Free Sale (FSC) for medical device exports. We dissect the critical differences between the regulatory frameworks in the United States and the European Union, explaining precisely who—from manufacturer to exporter to authorized representative—can legally apply for this essential market access document in each region. Key Questions: • What is a Certificate of Free Sale (FSC) and why do exporters need it? • In

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03:05

Unlocking the FDA 510(k) with Your Japanese PMDA...

Medical Device Global Market Access ·

2025/09/07

Many companies believe that getting medical device approval in Japan might fast-track their entry into the U.S. market. This episode breaks down that misconception and reveals the strategic pathway that actually exists. We explore how the FDA’s Abbreviated 510(k) program allows manufacturers to leverage their existing PMDA data, focusing on the crucial role of internationally recognized consensus standards. Learn how this approach can save significant time and resources compared to a traditional

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03:52

From China to Brazil: Navigating ANVISA without NMPA...

Medical Device Global Market Access ·

2025/09/06

This episode clarifies whether a medical device approved by China's NMPA can benefit from an expedited registration process with Brazil's ANVISA. We detail the full Brazilian regulatory requirements, including classification, the role of a Brazil Registration Holder (BRH), B-GMP certification, and the AREE program, explaining why NMPA approval doesn't currently offer a shortcut. • Can my Chinese NMPA approval speed up device registration in Brazil? • What is the AREE program, and which countries

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03:44

From Brazil to the US: Unpacking ANVISA and FDA...

Medical Device Global Market Access ·

2025/09/05

This episode tackles a common question from MedTech manufacturers: can a successful ANVISA registration in Brazil streamline the path to FDA 510(k) clearance in the United States? We explore the reality of regulatory reliance between these two key markets, clarifying the one-way nature of current frameworks and outlining how your existing ANVISA technical documentation can still provide a significant advantage for your US submission.• Does the FDA recognize or have a reliance pathway for

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03:55

From NMPA to CE Mark: Bridging the Regulatory Gap

Medical Device Global Market Access ·

2025/09/04

This episode breaks down the essential differences between China's NMPA approval and the EU's rigorous MDR CE marking process. We explore the key gaps in regulatory philosophy, clinical data requirements, and post-market surveillance that manufacturers must bridge to expand from the Chinese to the European market.Key Questions: • Is my NMPA approval enough to get a CE mark in Europe? • What is the difference between a Notified Body and the NMPA? • How do EU MDR requirements for a Clinical

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04:33

From NMPA to FDA: Leveraging China Approval for U.S....

Medical Device Global Market Access ·

2025/09/03

This episode details the process for medical device manufacturers to obtain FDA 510(k) clearance in the United States after securing Class III approval from China's NMPA. We explain that there is no direct reciprocity and outline how to strategically leverage existing Chinese technical documentation, clinical data, and testing reports. The focus is on conducting a thorough gap analysis to meet the FDA's unique requirements, particularly the concept of "substantial equivalence" to a predicate device

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03:24

From Tokyo to Brussels: Navigating the EU MDR After...

Medical Device Global Market Access ·

2025/09/03

Securing Shonin approval in Japan is a huge regulatory achievement, but it doesn’t guarantee a simple path to the European market. This episode breaks down the key differences between Japan's PMD Act and the EU's demanding Medical Device Regulation (MDR). We explore the critical gaps manufacturers must address in their Quality Management System, technical documentation, clinical evidence, and post-market surveillance strategies to successfully obtain a CE Mark.Key Questions: • Can I reuse my

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03:27

From Europe to Down Under: A Guide to TGA Approval...

Medical Device Global Market Access ·

2025/09/02

This episode breaks down the process of using your existing European CE Marking to register a medical device in Australia. We cover the essential role of Manufacturer's Evidence, the TGA's application process and timelines, potential audits, and the latest on fees and charges, providing a clear roadmap for MedTech companies looking to enter the Australian market.Key Questions: • What is "Manufacturer's Evidence" and why is it the key to TGA approval? • How does my EU device classification

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03:48

De Novo Submissions: Will Your CE Mark Data Pass FDA...

Medical Device Global Market Access ·

2025/09/01

This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US requirements, and the strategic importance of the Pre-Submission program to de-risk market entry. • Can you directly use your CE mark clinical study for an FDA De Novo submission? • What are the most common data gaps the FDA identifies in European

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03:24

CE Mark to FDA 510(k): A Guide for MedTech Manufacturers

Medical Device Global Market Access ·

2025/08/31

This episode demystifies the process for manufacturers who have an EU CE mark under the MDR and are seeking FDA 510(k) clearance. We break down the crucial differences and similarities between the two regulatory systems, explaining how to leverage existing technical documentation and what new requirements and strategic considerations, like selecting a predicate device, you will face when entering the United States market.Key Questions: • Does an EU CE mark give my device an advantage with the

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03:53

From Europe to Japan: Leveraging Your CE Mark for...

Medical Device Global Market Access ·

2025/08/31

Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requirements for a Shonin application, explaining how manufacturers can leverage their existing CE mark data. We break down the critical differences and synergies between the EU and Japanese regulatory systems, from Quality Management Systems and technical documentation to the all-important clinical data requirements and the mandatory role of a local

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03:09

From Europe to Brazil: Bridging the CE Mark and...

Medical Device Global Market Access ·

2025/08/30

This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between European requirements and Brazil's ANVISA regulations, focusing on the essential documentation, testing, and certification gaps that manufacturers must address for successful registration. • Is a CE mark enough to sell your medical device in Brazil? • What is a Brazil Registration Holder (BRH) and why is it mandatory? • How does ANVISA's technical

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03:22

From MDR to NMPA: A Strategic Guide to China Market...

Medical Device Global Market Access ·

2025/08/29

This episode details the strategic process for transitioning a medical device with a European CE mark under MDR to achieve Class II or III registration with China's NMPA. We break down the unique requirements, from local representation to in-country testing and clinical evaluation pathways, providing a clear roadmap for manufacturers looking to enter the complex but lucrative Chinese market. Key Questions: • Is a CE mark sufficient for selling a medical device in China? • What is a Product

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03:30

Unlocking the Canadian MedTech Market: Beyond the CE...

Medical Device Global Market Access ·

2025/08/28

This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for selling in Canada. We break down the crucial differences between an MDEL and a product-specific Medical Device Licence (MDL), clarify who needs to hold an MDEL, and explain why having a CE mark is not a substitute for this essential Canadian requirement. Learn about the key procedural documentation needed for a successful application and the latest

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03:49

From CE to UKCA: Navigating the UK Medical Device...

Medical Device Global Market Access ·

2025/08/28

This episode breaks down the essential steps for medical device manufacturers with a CE mark to comply with UK regulations for Great Britain. We cover the extended deadlines for CE mark recognition, the immediate requirements for MHRA registration and appointing a UK Responsible Person (UKRP), and the process for achieving UKCA conformity assessment. Learn the key dates and actions you need to take to ensure uninterrupted market access.Key Questions: • Is my CE mark still valid for selling medical

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