Hosted by Pure Global · 🇺🇸 US · EN · 360 episodes
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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 regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to t
Pure Global hosts Medical Device Global Market Access, a technology show with 360 episodes published.
This episode covers the EU's new MDCG 2026-4 guidance, which transfers the responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) from Notified Bodies to manufacturers. We discuss the impact o
China's NMPA is rapidly approving innovative medical devices, creating a major opportunity for global manufacturers. A new report reveals that 40 innovative devices were approved in the first half of 2026, bringing the t
Australia's Therapeutic Goods Administration (TGA) is launching its Unique Device Identification (UDI) system, with the first major compliance deadline set for July 1, 2026. This episode details the new requirements for
India's Central Drugs Standard Control Organisation (CDSCO) has published a draft amendment to shorten the approval timelines for medical device manufacturing licenses. This episode details the proposed reductions for Cl
This episode details the critical amendments to South Korea's Medical Device Act, which took effect on July 1, 2026. The host breaks down the two main changes from the Ministry of Food and Drug Safety (MFDS): the establi
The FDA's June 6, 2026 draft guidance introduces significant new requirements for AI-enabled medical devices, focusing on total product lifecycle management. This episode breaks down the key changes, including stricter r
Health Canada has finalized Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with new rules taking effect on December 14, 2026. This episode breaks down the three most significant changes impacti
Australia's TGA has amended medical device classification rule 5.5, effective July 1, 2024. The change removes materials of microbial and recombinant origin from the scope of the rule, which previously mandated a Class I
Switzerland's swissdamed database becomes mandatory on July 1, 2026, for all medical devices and IVDs. This episode details the key deadlines, including the transition period until December 31, 2026, for existing devices
This episode details the UK MHRA's draft Medical Devices (Amendment) Regulations 2026, focusing on the proposed International Reliance pathway. We explore how this new framework aims to streamline market access in Great
Brazil's ANVISA has updated its review process for the regulatory reliance pathway under IN 290/2024. As of mid-June 2024, instead of rejecting submissions with minor issues, the agency will now issue requirement notices
This episode provides a detailed analysis of China's NMPA new post-market vigilance framework, released on June 12, 2026. We discuss the mandatory, risk-based system that introduces new obligations for foreign medical de
On June 22, 2026, the Saudi Food and Drug Authority (SFDA) issued a landmark marketing authorization for an AI-powered mobile application that measures vital signs using a smartphone camera. We break down the technology
The UK's MHRA announced on June 22, 2026, its intention to become a full member of the Medical Device Single Audit Program (MDSAP). This episode explores the significant impact of this decision on medical device manufact
Singapore's Health Sciences Authority (HSA) is reclassifying all COVID-19 in-vitro diagnostic (IVD) tests from the highest-risk Class D to Class C, effective June 2, 2026. This episode details the reasons for this regula
India's drug regulator, the CDSCO, has proposed a new framework to allow hospitals to directly import a list of 80 high-end medical devices, such as MRI and CT scanners. This episode explores the potential policy shift,
Health Canada issued a public advisory on June 16, 2026, warning that unauthorized soft-shelled hyperbaric chambers are illegal to sell, import, or advertise in Canada. This episode breaks down the specific health risks
In this episode, we break down Mexico's new comprehensive medical device labeling standard, NOM-137-SSA1-2025, published by the health regulator COFEPRIS. We explore the key changes from the previous 2008 version, includ
In this episode, we explore the U.S. FDA's significant new guidance on Human Factors Engineering (HFE) for medical devices. The host breaks down the new three-tiered, risk-based framework for HFE submissions, which impac
This episode details the critical EUDAMED deadline of May 28, 2026, when four key modules become mandatory for medical device and IVD manufacturers in the EU. We explain the immediate legal obligation to register all new
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Medical Device Global Market Access is hosted by Pure Global. The show is categorised under technology and has published 360 episodes.
Medical Device Global Market Access has published 360 episodes.
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