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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

04:50

ANVISA Chile ISP Cooperation: Preparing for Latin...

Medical Device Global Market Access ·

2026/08/08

This episode explores the technical exchange held between Brazil's ANVISA and Chile's ISP from July 6-10, 2026. We analyze the key topics discussed—including Brazilian Good Manufacturing Practices (BGMP), import controls, and post-market surveillance—and explain how this collaboration signals a significant move toward regulatory convergence in Latin America. We outline the practical implications for medical device manufacturers and provide concrete steps for regulatory teams to prepare for a more

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05:05

FDA Human Factors Guidance 2026: What 510(k) and PMA...

Medical Device Global Market Access ·

2026/08/07

This episode provides a detailed analysis of the U.S. FDA's final guidance on 'Content of Human Factors Information in Medical Device Marketing Submissions,' issued on August 3, 2026. We break down the specific human factors and usability engineering documentation now required for premarket submissions like 510(k)s and PMAs. Learn what the FDA expects to see in your HFE report, who is affected by these changes, and practical steps your team can take to ensure a compliant and successful

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04:38

FDA Non-Device Software Functions: Public Input...

Medical Device Global Market Access ·

2026/08/06

The US FDA has issued a request for public input, due by August 13, 2026, on the risks and benefits of software functions excluded from the medical device definition. This feedback will inform the FDA's 2026 biennial report to Congress on patient safety, potentially shaping the future of digital health regulation for wellness apps, EHRs, and certain clinical decision support tools. This episode covers the background, who is affected, key deadlines, and practical steps for software developers.Key

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05:16

Mexico COFEPRIS Equivalence Pathway: New Guidance for...

Medical Device Global Market Access ·

2026/08/05

Mexico's COFEPRIS released new guidance in late July 2026 clarifying documentation requirements for its Equivalence and Abbreviated regulatory pathways. This episode provides a practical breakdown of the key changes affecting medical device and IVD manufacturers. We discuss the updated specifications for critical documents like the Certificate of Free Sale and Letter of Equivalence, who is impacted by these immediate changes, and actionable steps your regulatory team can take to ensure your

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05:31

FDA Guidance on Hemodialysis Blood Tubing Sets: Key...

Medical Device Global Market Access ·

2026/08/04

The FDA has issued its final guidance for 510(k) submissions for Hemodialysis Blood Tubing Sets, replacing a 40-year-old document. This episode breaks down the new, detailed recommendations for device description, performance testing, sterilization, and labeling. We discuss the key consensus standards, such as ISO 8637 and ISO 10993, and explain the FDA's heightened expectations for mechanical, chemical, and biocompatibility data. We also outline practical steps that regulatory, quality, and R&D

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05:19

UK MHRA AI Scribe Guidance: Clarifying Regulatory...

Medical Device Global Market Access ·

2026/08/03

The UK's MHRA issued guidance on July 29, 2026, clarifying that certain Ambient Voice Technology (AVT), or 'AI scribes,' are not regulated as medical devices if their function is purely administrative. This episode details the specific functions, such as transcription and summarization for clinician review, that fall outside the regulation's scope. We explore how this clarification creates a faster, more streamlined path to the UK market for manufacturers and outline the critical steps that

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05:12

SFDA Used Medical Device Resale: New Warning and...

Medical Device Global Market Access ·

2026/08/02

This episode details the Saudi Food and Drug Authority's (SFDA) public warning issued on July 28, 2026, regarding the non-compliant resale, auction, lending, or donation of used medical devices. We explore how this action enforces Article 20 of Regulation No. 1/1443 and what it means for healthcare establishments. We cover the specific requirements, including the need for a valid Medical Device Marketing Authorization (MDMA) and the obligation to transfer complete technical documentation to the new

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05:14

UK MHRA AI Scribe Regulation: New Guidance for...

Medical Device Global Market Access ·

2026/08/01

This episode breaks down the UK MHRA's new guidance issued on July 29, 2026, clarifying when Ambient Voice Technology (AVT), or 'AI Scribes,' are regulated as medical devices. We explain the critical distinction: products for simple transcription or note-drafting with clinician review are not devices, while those supporting diagnosis or automated actions are. We cover the implications for AI developers and NHS providers and outline practical steps for compliance and safe adoption under the UK

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05:10

China NMPA 2026 Guidelines: Navigating 57 New Medical...

Medical Device Global Market Access ·

2026/07/31

On July 21, 2026, China's NMPA issued 57 new final guidelines for medical devices in a single day, creating a significant new compliance challenge for manufacturers. This episode explores the scope of these guidelines, which cover a wide range of products from cardiovascular to anesthesiology, and outlines the immediate actions required for both new registrations and renewals. We discuss how these changes impact technical documentation, testing protocols, and clinical evidence, providing practical

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05:23

TGA AI Medical Device Regulation: Preparing for...

Medical Device Global Market Access ·

2026/07/30

Australia's Therapeutic Goods Administration (TGA) has issued new guidance clarifying when AI-enabled software is regulated as a medical device (SaMD). This episode breaks down the TGA's focus on intended purpose, the specific evidence required for safety and performance, and why SaMD has been designated a key compliance and enforcement priority for 2026-2027. We outline the practical steps manufacturers must take now to review their product classification, update technical documentation, and

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04:36

Malaysia MDA Product Classification: Mandatory Online...

Medical Device Global Market Access ·

2026/07/29

Malaysia's Medical Device Authority (MDA) is mandating fully online submissions for all medical device product classification applications starting August 1, 2026. This episode details the transition to the new Product Classification Application System (PCAS), explains the impact on manufacturers seeking market access in Malaysia, and provides practical steps for regulatory teams to prepare for this digital-only process to avoid delays.Key Questions: - What is the new requirement from Malaysia's

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04:53

FDA's MDUFA VI Draft Commitment Letter: Key Proposals...

Medical Device Global Market Access ·

2026/07/28

This episode details the US FDA's newly released draft commitment letter for the sixth Medical Device User Fee Act (MDUFA VI), which will govern fiscal years 2028 through 2032. We explore the key proposals, including a significant expansion of the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, updated review performance goals, and a focus on digital health. We also highlight the critical public comment deadline of August 7, 2026, and provide practical steps for manufacturers to

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04:28

South Korea MFDS Proposal for Digital Medical Device...

Medical Device Global Market Access ·

2026/07/27

South Korea's Ministry of Food and Drug Safety (MFDS) has released Legislative Notice No. 2026-341, a proposal to amend the rules for medical device testing. This episode breaks down the most significant change: officially allowing medical device testing institutions to test digital medical devices, including Software as a Medical Device (SaMD) and AI-based technologies. We discuss what this means for manufacturers seeking market access in South Korea, the revised administrative penalty criteria for

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04:27

Saudi Arabia SFDA Medical Device Advertising: New...

Medical Device Global Market Access ·

2026/07/26

This episode provides a detailed analysis of the Saudi Food and Drug Authority's (SFDA) new requirements for medical device advertising, outlined in MDS-REQ 8, published on July 20, 2026. We cover the scope of the regulation, which mandates pre-approval for all promotional and awareness materials across all media platforms. We explain the submission process, the SFDA's review criteria for ensuring accuracy and truthfulness in advertising, and who is responsible for compliance. The host outlines

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05:08

India's 2026 CDSCO Guidance on Medical Device...

Medical Device Global Market Access ·

2026/07/25

This episode covers India's CDSCO final guidance for Medical Device Software (MDSW), released on July 23, 2026. We discuss the key compliance requirements for manufacturers and importers under the Medical Devices Rules, 2017, including new expectations for technical documentation, usability validation for Indian clinical workflows, risk management for cybersecurity and AI bias, and the mandatory Software Bill of Materials (SBOM). Learn the actionable steps your regulatory and quality teams need to

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05:39

FDA eMDR System Enhancements 2026: A Guide for...

Medical Device Global Market Access ·

2026/07/24

On July 20, 2026, the US FDA announced major enhancements to the electronic Medical Device Reporting (eMDR) system, impacting all manufacturers required to submit adverse event reports. This episode provides a practical guide to understanding the new structured data requirements, enhanced validation rules, and updated submission APIs. We cover the mandatory compliance deadline of January 1, 2027, and outline actionable steps for regulatory and quality teams to update SOPs, train staff, and ensure

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05:12

China NMPA Draft GMP Inspection Guideline: Risk-Based...

Medical Device Global Market Access ·

2026/07/23

China's NMPA has released a draft 'Guideline for Inspection under the Medical Device Good Manufacturing Practices', signaling a major shift towards a risk-based, lifecycle-oriented audit approach. This episode breaks down the implications of this new framework, released for comment on June 9, 2026. We detail the importance of the 39 newly designated "critical check items" and explain how a failure in any one of these areas could lead to severe regulatory consequences. We also provide practical,

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04:15

ANVISA Medical Device Regulation 2026: Brazil and...

Medical Device Global Market Access ·

2026/07/22

Brazil's ANVISA and Chile's ISP held a technical exchange from July 6-10, 2026, to deepen regulatory cooperation. This episode explores the key topics discussed—including Brazilian GMP certification, import controls, and post-market surveillance—and analyzes the implications for medical device manufacturers. We discuss how this collaboration supports the broader trend of regulatory convergence in Latin America and what practical steps companies can take to prepare for a more harmonized market.Key

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04:47

ANVISA Technovigilance Changes in Brazil: What to...

Medical Device Global Market Access ·

2026/07/21

This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework. We discuss the implications for medical device manufacturers, the expected changes to adverse event reporting and post-market surveillance, and practical steps to prepare for the upcoming regulations in Brazil. Key Questions: - What does the closing of ANVISA's public consultation on technovigilance mean for the industry? - How will the new framework

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04:40

South Korea Medical Device Act 2026: MFDS QMS and...

Medical Device Global Market Access ·

2026/07/20

This episode details the significant amendments to South Korea's Medical Device Act, effective July 1, 2026. We cover the two key changes from the Ministry of Food and Drug Safety (MFDS): the formalization of the Quality Management System (QMS) Conformity Recognition Scheme and the new mandatory supply chain record-keeping rules. We explore the impact on manufacturers, importers, and distributors and provide actionable steps for regulatory and quality teams to ensure compliance with these new

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