Shows / Medical Device Global Market Access
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…
Episodes
- Medical Device Global Market Access
UK MHRA Indefinite CE Marking Recognition: A New Era for Great Britain Market Access
The UK MHRA has announced a major policy shift: it will indefinitely recognize CE-marked medical devices that comply with the EU's MDR and IVDR. This episode…
- Medical Device Global Market Access
South Korea MFDS Innovative Device Approval: The 240-Day Fast-Track Plan
South Korea's Ministry of Food and Drug Safety (MFDS) has renewed its commitment to the 'Medical Product Approval and Review Innovation Plan,' aiming to…
- Medical Device Global Market Access
China NMPA GMP Inspection Guideline: Preparing for the November 1, 2026 Deadline
China's NMPA has released its final Good Manufacturing Practice (GMP) inspection guideline, which becomes mandatory on November 1, 2026. This episode provides…
- Medical Device Global Market Access
China NMPA GMP 2026: Preparing for Stricter Quality System Requirements
China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices starting November 1, 2026…
- Medical Device Global Market Access
Indonesia Halal Certification for Class A Medical Devices: The October 18, 2026 Deadline
Indonesia is implementing mandatory Halal certification for Class A medical devices, with a critical deadline of October 18, 2026. This episode breaks down…
- Medical Device Global Market Access
Swissmedic swissdamed Importer Linking: April 1, 2027 Deadline for Medical Device Importers
Swissmedic has activated the importer linking function in the swissdamed database as of October 1, 2026. This creates a new mandatory step for Swiss importers…
- Medical Device Global Market Access
EU Joint Clinical Assessment: First High-Risk Medical Devices Selected Under HTAR
On October 6, 2026, the European Commission selected the first group of high-risk medical devices to undergo a Joint Clinical Assessment (JCA) under the new EU…
- Medical Device Global Market Access
Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits
Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits…
- Medical Device Global Market Access
TGA AI Medical Scribe Regulation: When Clinical Software Becomes a Medical Device
Australia's Therapeutic Goods Administration (TGA) has clarified that many AI-powered digital scribes are considered medical devices, not simple administrative…
- Medical Device Global Market Access
Japan PMDA Generative AI Guidance: Key Review Points for Medical Device Manufacturers
On October 14, 2026, Japan's PMDA published its draft guidance, 'Review Points for Medical Devices Utilizing Generative AI.' This episode explores the key…
- Medical Device Global Market Access
Health Canada Medical Device Shortage Guidance: Exceptional Importation and Sale Updates
Health Canada has released revised guidance on its framework for exceptional importation and sale of medical devices, effective October 16, 2026. This episode…
- Medical Device Global Market Access
FDA Draft Guidance for Robotically Assisted Surgical Devices: Premarket Submission Insights
On October 9, 2026, the US FDA issued new draft guidance clarifying premarket submission requirements for robotically assisted surgical (RAS) devices. This…
- Medical Device Global Market Access
FDA GenAI Medical Device Regulation: Key Considerations Before the October 19, 2026 Comment Deadline
The US FDA is considering a new 'total product lifecycle' approach for regulating medical devices that use Generative AI (GenAI). This episode breaks down the…
- Medical Device Global Market Access
Singapore HSA-ACE Priority Track: Faster Market Access for Innovative Medical Devices
Singapore's Health Sciences Authority (HSA) has announced a new priority pathway for innovative medical devices, launching in November 2026. The 'HSA-Agency…
- Medical Device Global Market Access
South Korea MFDS Proposes Faster Class II Medical Device Certification
South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a new one-stop certification and technical review process for Class II medical devices. This…
- Medical Device Global Market Access
Brazil ANVISA SaMD & AI Vigilance Rules: Mid-October 2026 Feedback Deadline
Brazil's ANVISA has launched Public Call No. 4/2026 to revise its Tecnovigilância (post-market vigilance) framework, specifically seeking industry feedback on…
- Medical Device Global Market Access
FDA 510(k) Exemption for Clinical Toxicology Devices: What IVD Makers Need to Know
The US FDA issued a final order on October 5, 2026, exempting certain Class II clinical toxicology test systems from 510(k) premarket notification…
- Medical Device Global Market Access
India's Revised Materiovigilance (MvPI) Guidelines: Expanded Scope for Software, AI, and Cybersecurity
India has significantly overhauled its medical device safety monitoring framework. Effective October 9, 2026, the revised Materiovigilance Programme of India…
- Medical Device Global Market Access
Australia TGA Proposes Greater Medical Device Transparency: What Sponsors Need to Know
This episode explores the Australian Therapeutic Goods Administration (TGA)'s recent consultation on increasing the public sharing of medical device…
- Medical Device Global Market Access
UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers
The UK government has committed the MHRA to a new lifecycle-based regulatory framework for AI-enabled medical devices, moving away from one-time pre-market…
- Medical Device Global Market Access
UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3
The UK government has accepted all 44 recommendations for regulating AI in healthcare, marking a major policy shift for the MHRA. As of October 6, 2026, the UK…
- Medical Device Global Market Access
China NMPA's Revised GMP: What Manufacturers Must Do by the November 2026 Deadline
China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices, with a compliance…
- Medical Device Global Market Access
Health Canada MDEL Amendments 2026: New Rules for Distributors and Importers
Health Canada's amended Medical Devices Regulations introduce major changes effective December 14, 2026. This episode breaks down the new MDEL exemption for…
- Medical Device Global Market Access
Indonesia Halal Certification: Class A Medical Device Deadline on October 17, 2026
Indonesia is enforcing mandatory Halal certification for medical devices, with the first deadline for low-risk Class A devices set for October 17, 2026. This…
- Medical Device Global Market Access
UK MHRA Wireless CTG Safety Alert: Post-Market Actions for Manufacturers
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…
- Medical Device Global Market Access
Japan PMDA SaMD Guidance: 2026 Update and Submission Strategy
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…
- Medical Device Global Market Access
UK MHRA Patient Hoist Safety Alert: Actions for NatPSA/2026/005/MHRA by September 2026
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…
- Medical Device Global Market Access
SFDA Medical Device Advertising Compliance: Responding to New Enforcement Actions
The Saudi Food and Drug Authority (SFDA) has taken enforcement action against a medical device company for non-compliant advertising, signaling a stricter…
- Medical Device Global Market Access
TGA CDSS Exemption Changes: Preparing for the November 1, 2026 Deadline
Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), with significant changes…
- Medical Device Global Market Access
Japan PMDA Generative AI: New Draft Criteria for Programmed Medical Devices
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…
- Medical Device Global Market Access
FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions
The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical Devices…
- Medical Device Global Market Access
EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026
This episode covers the significant procedural change announced in MDCG 2026-4, where medical device and IVD manufacturers will now be responsible for…
- Medical Device Global Market Access
Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules
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)…
- Medical Device Global Market Access
EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials
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…
- Medical Device Global Market Access
Brazil ANVISA High-Risk Device Registration: Navigating Public Consultation 1248
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…
- Medical Device Global Market Access
UK MHRA Health Bill Amendments: Future of Medical Device Licensing
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…
- Medical Device Global Market Access
FDA's New PMA Electronic Submission Template: Draft Guidance Explained
This episode details the US FDA's new draft guidance on an electronic submission template for Premarket Approval (PMA) applications, issued on September 17…
- Medical Device Global Market Access
MFDS Korea Post-Market Study Exemption: Leveraging Overseas Data Under Notice 2026-63
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…
- Medical Device Global Market Access
Health Canada Exceptional Importation: Navigating the Updated Forms for Medical Device Shortages
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…
- Medical Device Global Market Access
China NMPA GMP Inspection Guidance: Preparing for the November 1, 2026 Deadline
China's NMPA has released new mandatory GMP Inspection Guidance Principles, effective November 1, 2026. This episode breaks down the critical changes…
- Medical Device Global Market Access
FDA Radiology AI Software 510(k) Exemption: Final Order Clarifies Pathways for CADe/CADx Devices
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…
- Medical Device Global Market Access
China NMPA BCI Standard: New Rules for AI-Powered Medical Devices
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…
- Medical Device Global Market Access
China NMPA Policy on Localizing Imported Medical Device Production
China's NMPA issued a notice on September 9, 2026, significantly streamlining the regulatory process for foreign manufacturers to localize the production of…
- Medical Device Global Market Access
Mexico COFEPRIS Authorized Third Parties: New 4-Year Validity and Operating Guidelines
Mexico's health regulator, COFEPRIS, has updated the operational guidelines for Authorized Third Parties (ATPs), effective September 3, 2026. This episode…
- Medical Device Global Market Access
SFDA AI Medical Software: Market Access in Saudi Arabia After First SaMD Approvals
The Saudi Food and Drug Authority (SFDA) has approved its first two locally developed AI-enabled Software as a Medical Device (SaMD) products, 'Dental IQ' and…
- Medical Device Global Market Access
Australia TGA CDSS Exemption 2026: What SaMD Manufacturers Need to Know
Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), effective November 1…
- Medical Device Global Market Access
India CBIC Medical Device Import Checklist: New Customs Clearance Requirements
India's Central Board of Indirect Taxes and Customs (CBIC) has introduced a new standardized checklist for the import clearance of medical devices, effective…
- Medical Device Global Market Access
China NMPA's Dynamic Adjustment of Medical Device Classification: What Manufacturers Need to Know
This episode details China NMPA's new 'dynamic adjustment' mechanism for medical device classification, introduced in Announcements No. 52 and 53 on September…
- Medical Device Global Market Access
SFDA Medical Device Advertising: Responding to Enforcement in Saudi Arabia
On September 6, 2026, the Saudi Food and Drug Authority (SFDA) announced legal action against a medical device company for misleading advertising. This episode…
- Medical Device Global Market Access
Australia TGA Device Classification Rules: Saline Flush Syringes Reclassified to Class IIa
Australia's Therapeutic Goods Administration (TGA) has introduced a new classification rule, Clause 2.2, that reclassifies non-invasive devices containing only…
- Medical Device Global Market Access
China NMPA Approves LEQEMBI Autoinjector: A Signal for Drug-Device Combination Products
This episode examines the September 3, 2026, approval of the LEQEMBI (lecanemab) subcutaneous autoinjector by China's NMPA. We explore how this shift from…
- Medical Device Global Market Access
Brazil ANVISA High-Risk Device Registration: Public Consultation No. 1,248 Explained
This episode details Brazil ANVISA's Public Consultation No. 1,248, published on August 26, 2026, which proposes a new regulatory framework for the…
- Medical Device Global Market Access
Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know
Brazil's ANVISA has published two new guidance manuals detailing the 'notification' pathway for Class I and II medical devices and IVDs. This episode explains…
- Medical Device Global Market Access
Singapore HSA's New Registration Pathway for Special Access Route (SAR) Devices
Singapore's Health Sciences Authority (HSA) launched a Registration Support Initiative on August 28, 2026, to help transition clinically important medical…
- Medical Device Global Market Access
UK MHRA Health Bill Amendments 2026: New Powers for Future Device Regulation
The UK government has proposed three amendments to the Health Bill, introduced on September 1, 2026, that grant significant new powers to the MHRA. This…
- Medical Device Global Market Access
UK MHRA's New Licensing Powers: What the 2026 Health Bill Amendments Mean for Medical Device Manufacturers
This episode explores the significant amendments to the UK Health Bill introduced on September 1, 2026, which grant the MHRA new powers to establish a future…
- Medical Device Global Market Access
UK MHRA Non-Compliant Devices: DSI/2026/007 and Supply Chain Risks
The UK's MHRA has issued Device Safety Information notice DSI/2026/007, warning of non-compliant medical devices on the UK market lacking valid UKCA or CE…
- Medical Device Global Market Access
Australia TGA Consultation on Medical Device Information Sharing: What Sponsors Need to Know
Australia's Therapeutic Goods Administration (TGA) has launched a consultation on proposals to increase the public sharing of medical device information. This…
- Medical Device Global Market Access
Health Canada Special Access Program: New Application Process for Medical Devices
Health Canada has modernized the application process for its Medical Devices Special Access Program (SAP) as of August 24, 2026. This episode details the two…
- Medical Device Global Market Access
UK MHRA ResMed Astral Alert: Ventilator Safety Actions for NatPSA/2026/004/MHRA
The UK's MHRA issued National Patient Safety Alert NatPSA/2026/004/MHRA on August 17, 2026, for ResMed Astral 100 and 150 ventilators manufactured before…