Loading...

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

05:27

UK MHRA Wireless CTG Safety Alert: Post-Market...

Medical Device Global Market Access ·

2026/10/05

This episode examines the UK MHRA's Device Safety Information (DSI/2026/012), issued on September 29, 2026, which details critical safety risks for wireless cardiotocography (CTG) monitoring systems. We break down the identified risks of signal crossover and dropouts, the MHRA's required actions for healthcare providers, and the significant post-market compliance and risk management implications for manufacturers of RF-enabled medical devices.Key Questions: - What specific risks did the MHRA

en

05:29

Japan PMDA SaMD Guidance: 2026 Update and Submission...

Medical Device Global Market Access ·

2026/10/04

On September 18, 2026, Japan's PMDA released a major update to its guidance for Software as a Medical Device (SaMD). This episode breaks down the key changes in the revised guide, including new requirements for AI/ML and cybersecurity. We analyze what the new PMDA seminar materials and consultation schedule mean for manufacturers' submission strategies and market access timelines, providing practical steps for regulatory and quality teams to ensure compliance.Key Questions: - What are the most

en

05:14

UK MHRA Patient Hoist Safety Alert: Actions for...

Medical Device Global Market Access ·

2026/10/03

This episode details the UK MHRA's National Patient Safety Alert (NatPSA/2026/005/MHRA) on the risks of death and serious harm from falls involving patient hoists and slings. We cover the specific mechanical and user-related failures identified by the MHRA, the comprehensive actions required of manufacturers and healthcare providers, and the critical compliance deadline of September 29, 2026. Learn the practical steps your quality, regulatory, and clinical teams must take to ensure patient safety

en

05:12

SFDA Medical Device Advertising Compliance:...

Medical Device Global Market Access ·

2026/10/02

The Saudi Food and Drug Authority (SFDA) has taken enforcement action against a medical device company for non-compliant advertising, signaling a stricter approach to market surveillance. This episode breaks down the SFDA's announcement on September 7, 2026, the specific violations related to inaccurate and exaggerated claims, and the potential for fines up to SR5 million. We discuss the implications for all manufacturers in the Saudi market and provide practical, actionable steps for regulatory and

en

05:18

TGA CDSS Exemption Changes: Preparing for the...

Medical Device Global Market Access ·

2026/10/01

Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), with significant changes taking effect on November 1, 2026. This episode details the two new mandatory conditions for exemption: the software cannot be intended to make a diagnosis or treatment decision, and its underlying logic must be transparent to the healthcare professional. We explain who is affected, what these changes mean in practice, and the critical steps

en

06:21

Japan PMDA Generative AI: New Draft Criteria for...

Medical Device Global Market Access ·

2026/09/30

On September 18, 2026, Japan's PMDA published draft review criteria for programmed medical devices (SaMD) that use generative AI, such as LLMs. This episode breaks down the PMDA's key areas of focus, including requirements for defining intended use, managing training data, evaluating model performance, and planning for the device's entire lifecycle. We discuss the implications for manufacturers targeting the Japanese market and outline practical steps that regulatory and quality teams should take

en

05:27

FDA Robotic Surgery Guidance: Key Changes for...

Medical Device Global Market Access ·

2026/09/29

The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical Devices (RASDs). This episode breaks down the key recommendations covering non-clinical testing, clinical data requirements, and specific labeling considerations. We also highlight the critical November 24, 2026, deadline for submitting comments and provide practical steps for manufacturers to align their regulatory strategies with the FDA's current

en

04:59

EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates...

Medical Device Global Market Access ·

2026/09/28

This episode covers the significant procedural change announced in MDCG 2026-4, where medical device and IVD manufacturers will now be responsible for uploading the Summary of Safety and (Clinical) Performance (SSCP/SSP) to the EUDAMED database. We explain how this shifts the task from Notified Bodies to manufacturers of Class III, implantable, and Class C/D IVD devices, effective with the launch of new EUDAMED functionality in October 2026. The host details the practical implications and provides

en

05:01

Brazil ANVISA Medical Device Vigilance: Public Call...

Medical Device Global Market Access ·

2026/09/27

Brazil's ANVISA has opened Public Call No. 4/2026, seeking industry feedback on a major revision of its medical device post-market vigilance (Tecnovigilância) framework. With a specific focus on the challenges posed by Software as a Medical Device (SaMD) and AI, this consultation offers a critical opportunity for manufacturers to influence future regulations. This episode breaks down the scope of the proposed changes, the strategic importance of participating, and the key deadline of mid-October

en

05:59

EU MDCG 2020-16 Rev 5: IVDR Classification for IVD...

Medical Device Global Market Access ·

2026/09/26

This episode details the September 9, 2026 update to the EU's MDCG 2020-16 guidance, Revision 5. We explain the crucial clarifications on classifying in-vitro diagnostic (IVD) quality control (QC) materials under the IVDR. The discussion focuses on the distinction between QC materials with manufacturer-assigned values versus those with only indicative values, and how this directly impacts a product's risk class and its required conformity assessment pathway, including the need for notified body

en

05:05

Brazil ANVISA High-Risk Device Registration:...

Medical Device Global Market Access ·

2026/09/25

Brazil's ANVISA has released Public Consultation No. 1248, proposing a major overhaul of the registration process for Class III and IV high-risk medical devices. This episode breaks down the key changes, including the shift to an IMDRF-aligned technical dossier, heightened requirements for clinical evidence and risk management, and the critical 45-day feedback period closing in October 2026. We discuss who is affected and outline practical steps for manufacturers to prepare and provide feedback

en

04:33

UK MHRA Health Bill Amendments: Future of Medical...

Medical Device Global Market Access ·

2026/09/24

The UK government tabled three amendments to the Health Bill on September 1, 2026, signaling a major overhaul of the MHRA's regulatory powers for medical devices. This episode breaks down the proposals, including new information-sharing capabilities, measures for faster regulatory updates, and enabling powers for a potential future direct-to-regulator licensing system that could replace the current UK Approved Body model. We analyze the long-term strategic implications for manufacturers and outline

en

04:55

FDA's New PMA Electronic Submission Template: Draft...

Medical Device Global Market Access ·

2026/09/23

This episode details the US FDA's new draft guidance on an electronic submission template for Premarket Approval (PMA) applications, issued on September 17, 2026. We explore which submission types are covered, such as Original PMAs and Panel-Track Supplements, and explain how the template aims to improve submission consistency and review efficiency for high-risk Class III medical devices. We also outline practical steps for regulatory and quality teams to prepare for this upcoming change.Key

en

05:38

MFDS Korea Post-Market Study Exemption: Leveraging...

Medical Device Global Market Access ·

2026/09/22

This episode breaks down South Korea's Ministry of Food and Drug Safety (MFDS) Notice No. 2026-63, which details new evidence requirements for obtaining a post-market study exemption. Effective August 31, 2026, this notice affects manufacturers of new and orphan medical devices. We explain the specific criteria for demonstrating sufficient overseas use, including the required post-market clinical experience, safety information, and international sales history. This episode provides actionable

en

04:29

Health Canada Exceptional Importation: Navigating the...

Medical Device Global Market Access ·

2026/09/21

This episode covers Health Canada's September 2, 2026, update to the forms for exceptional importation and sale of medical devices. We discuss the key changes, the criteria for using this pathway to address device shortages, and the practical steps manufacturers must take to prepare and submit successful applications.Key Questions: - What is Health Canada's exceptional importation pathway for medical devices? - What specific changes were made to the application forms on September 2, 2026? - How

en

05:16

China NMPA GMP Inspection Guidance: Preparing for the...

Medical Device Global Market Access ·

2026/09/20

China's NMPA has released new mandatory GMP Inspection Guidance Principles, effective November 1, 2026. This episode breaks down the critical changes, including the new deficiency classification system (critical, major, and minor) and the impact on both production-license and post-market inspections. We provide practical, actionable steps for medical device manufacturers to conduct gap analyses, update internal audit programs, and prepare their quality systems for this more stringent regulatory

en

05:24

FDA Radiology AI Software 510(k) Exemption: Final...

Medical Device Global Market Access ·

2026/09/19

The US FDA's final order on September 17, 2026, clarifies the partial 510(k) premarket notification exemption for specific AI/ML-driven radiology software. This episode breaks down the practical impact of this decision on manufacturers of computer-aided detection/diagnosis (CADe/CADx) and triage devices. We explain which devices are affected, why the FDA denied a broader exemption, and what the term "partial exemption" means for your regulatory strategy and US market access plans.Key Questions: -

en

05:40

China NMPA BCI Standard: New Rules for AI-Powered...

Medical Device Global Market Access ·

2026/09/18

China's NMPA has released the world's first product standard for AI-powered Brain-Computer Interface (BCI) medical devices, effective September 1, 2027. This episode breaks down the new technical requirements for the full data lifecycle—from acquisition and processing to storage and cybersecurity. We explore what this means for global manufacturers of AI/ML-enabled devices and outline practical steps for ensuring compliance to access the Chinese market.Key Questions: - What is the new NMPA

en

04:50

China NMPA Policy on Localizing Imported Medical...

Medical Device Global Market Access ·

2026/09/17

China's NMPA issued a notice on September 9, 2026, significantly streamlining the regulatory process for foreign manufacturers to localize the production of imported medical devices. This episode breaks down the key changes, including the ability to leverage original overseas registration materials for domestic submissions. We discuss which companies are affected, the requirements for demonstrating substantial equivalence, and the practical steps regulatory and quality teams should take to

en

05:30

Mexico COFEPRIS Authorized Third Parties: New 4-Year...

Medical Device Global Market Access ·

2026/09/16

Mexico's health regulator, COFEPRIS, has updated the operational guidelines for Authorized Third Parties (ATPs), effective September 3, 2026. This episode explores the two main changes: the new, standardized four-year validity period for ATP authorizations and the formal separation of administrative versus technical modifications. We discuss how these updates create a more stable and predictable regulatory environment for medical device manufacturers who use the ATP pathway to expedite their market

en

453 results

Similar Podcasts

Lead With AI

Tamara Nall

Elon Musk Podcast

Stage Zero

Modem Futura

Sean Leahy, Andrew Maynard

Cisco Podcast Network

Cisco

MSP Business School

MSP Business School