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
China NMPA Medical Device Approval: Analyzing the August 12, 2026 Batch
China's NMPA announced the approval of 122 medical devices on August 12, 2026, including many from leading international manufacturers such as Medtronic…
- Medical Device Global Market Access
Singapore HSA's New Medical Device Cybersecurity Guide (GL-10-R1): Key Principles and Actions
Singapore's Health Sciences Authority (HSA) has released its finalized 'Best Practices Guide for Medical Device Cybersecurity' (GL-10-R1), effective August 17…
- Medical Device Global Market Access
COFEPRIS Medical Device Sanitary Registry Viewer: What Manufacturers Need to Know
Mexico's health authority, COFEPRIS, has launched the Medical Device Sanitary Registry Viewer, a public digital tool for verifying device registrations. This…
- Medical Device Global Market Access
India CDSCO Amends Sterilization Rules: What Removing the Loan Licence Means for Medical Devices
India's CDSCO has amended the Medical Devices Rules, 2017, effective August 24, 2024, removing the 'loan licence' requirement for manufacturers who outsource…
- Medical Device Global Market Access
EU Notified Body Shake-Up: What the NSAI and TÜV NORD Exits Mean for MDR Certification
The EU Notified Body landscape was shaken in August 2024 with announcements that the National Standards Authority of Ireland (NSAI) will exit its MDR…
- Medical Device Global Market Access
Japan PMDA Workshop: A Guide to Medical Device Market Entry for U.S. Firms
Japan's PMDA and AdvaMed are hosting a free online workshop on September 1, 2026, for U.S.-based small and mid-sized medtech companies. This episode breaks…
- Medical Device Global Market Access
UK MHRA Rectal Catheter Alert: Infant Safety and Post-Market Lessons
This episode examines the UK MHRA's Device Safety Information alert (DSI/2026/008), issued on August 18, 2026, which advises against the use of rectal…
- Medical Device Global Market Access
Brazil ANVISA Innovative Device Pilot Program 2026: A Guide for High-Risk MedTech
Brazil's ANVISA has opened a new pathway for innovative, high-risk medical devices. On August 5, 2026, the agency published Call Notice 5/2026, inviting…
- Medical Device Global Market Access
SFDA Biocompatibility Requirements: Preparing Medical Device Submissions for Saudi Arabia
The Saudi Food and Drug Authority (SFDA) is increasing its focus on the biological evaluation of medical devices, highlighted by its upcoming workshop on…
- Medical Device Global Market Access
FDA Discussion Paper on Generative AI in Medical Devices: Feedback Deadline and Key Considerations
This episode details the US FDA's discussion paper on regulating medical devices incorporating Generative Artificial Intelligence (GenAI), released on August…
- Medical Device Global Market Access
FDA Proposed Rule on Class I Accessories: 2026 Changes for 510(k) Exemption
This episode covers the U.S. FDA's proposed rule from August 14, 2026, which aims to classify a specific list of medical device accessories as Class I. We…
- Medical Device Global Market Access
Saudi Arabia SFDA Medical Device Advertising Rules: MDS-REQ 8 Compliance for Manufacturers
The Saudi Food and Drug Authority (SFDA) has implemented new mandatory requirements for medical device advertising, effective July 20, 2026. This episode…
- Medical Device Global Market Access
CMS RAPID Coverage Pathway: Breakthrough Device Reimbursement Changes
The U.S. Centers for Medicare & Medicaid Services (CMS) has introduced a major policy change with the new Regulatory Alignment for Predictable and Immediate…
- Medical Device Global Market Access
Australia TGA Suspends Corpuls Defibrillators: What It Means for Post-Market Compliance
On August 12, 2026, Australia's Therapeutic Goods Administration (TGA) suspended the supply of Corpuls 3 and 3T defibrillators. This episode breaks down the…
- Medical Device Global Market Access
MHRA National Alert DSI/2026/007: Quarantining Devices Without UKCA or CE Marks
This episode examines the UK MHRA's national alert DSI/2026/007, issued on August 10, 2026, which mandates the quarantine of medical devices supplied without…
- Medical Device Global Market Access
MHRA Non-Compliant Medical Devices: UK Quarantine Order and Supply Chain Lessons
The UK's MHRA issued a Device Safety Information alert (DSI/2026/007) on August 10, 2026, ordering an immediate quarantine of six types of medical devices…
- Medical Device Global Market Access
FDA MDUFA VI Fees: Proposed Increases for Overseas Manufacturers
The US FDA is considering higher user fees for overseas medical device manufacturers under the proposed MDUFA VI agreement for fiscal years 2028-2032. This…
- Medical Device Global Market Access
India's Draft Drugs, Medical Devices and Cosmetics Bill 2026: Key Changes for Manufacturers
This episode covers India's draft Drugs, Medical Devices and Cosmetics Bill 2026, circulated for feedback on August 7, 2026. We discuss its proposal to replace…
- Medical Device Global Market Access
Health Canada MDEL Modernization: Preparing for Phase 2 Changes by December 2026
Health Canada is implementing Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with all changes coming into force on December 14…
- Medical Device Global Market Access
EU AI Act and Medical Devices: New Compliance Deadline of August 2, 2028
This episode covers the EU's postponement of the AI Act compliance deadline for high-risk AI medical devices to August 2, 2028. We discuss Regulation (EU)…
- Medical Device Global Market Access
China NMPA's 57 New Medical Device Guidelines: Immediate Impacts for Manufacturers
On July 21, 2026, China's NMPA released 57 new medical device guidelines, creating immediate compliance challenges for manufacturers. This episode breaks down…
- Medical Device Global Market Access
FDA Human Factors Guidance 2026: Navigating New eSTAR Requirements
The US FDA has finalized its guidance on 'Content of Human Factors Information in Medical Device Marketing Submissions,' introducing a new risk-based framework…
- Medical Device Global Market Access
ANVISA Chile ISP Cooperation: Preparing for Latin American Regulatory Convergence
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…
- Medical Device Global Market Access
FDA Human Factors Guidance 2026: What 510(k) and PMA Teams Need to Know
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,'…
- Medical Device Global Market Access
FDA Non-Device Software Functions: Public Input Deadline for 2026 Report
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…
- Medical Device Global Market Access
Mexico COFEPRIS Equivalence Pathway: New Guidance for Medical Device Registration
Mexico's COFEPRIS released new guidance in late July 2026 clarifying documentation requirements for its Equivalence and Abbreviated regulatory pathways. This…
- Medical Device Global Market Access
FDA Guidance on Hemodialysis Blood Tubing Sets: Key 510(k) Changes for July 23, 2026
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…
- Medical Device Global Market Access
UK MHRA AI Scribe Guidance: Clarifying Regulatory Status of AI Medical Scribes
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…
- Medical Device Global Market Access
SFDA Used Medical Device Resale: New Warning and Compliance Rules in Saudi Arabia
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…
- Medical Device Global Market Access
UK MHRA AI Scribe Regulation: New Guidance for Ambient Voice Technology
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 Device Global Market Access
China NMPA 2026 Guidelines: Navigating 57 New Medical Device Rules
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…
- Medical Device Global Market Access
TGA AI Medical Device Regulation: Preparing for 2026-2027 Enforcement in Australia
Australia's Therapeutic Goods Administration (TGA) has issued new guidance clarifying when AI-enabled software is regulated as a medical device (SaMD). This…
- Medical Device Global Market Access
Malaysia MDA Product Classification: Mandatory Online Submissions by August 2026
Malaysia's Medical Device Authority (MDA) is mandating fully online submissions for all medical device product classification applications starting August 1…
- Medical Device Global Market Access
FDA's MDUFA VI Draft Commitment Letter: Key Proposals and the August 7 Comment Deadline
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…
- Medical Device Global Market Access
South Korea MFDS Proposal for Digital Medical Device Testing: What Manufacturers Need to Know
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…
- Medical Device Global Market Access
Saudi Arabia SFDA Medical Device Advertising: New MDS-REQ 8 Requirements for Manufacturers
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…
- Medical Device Global Market Access
India's 2026 CDSCO Guidance on Medical Device Software (MDSW): Key Compliance Steps
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…
- Medical Device Global Market Access
FDA eMDR System Enhancements 2026: A Guide for Medical Device Manufacturers
On July 20, 2026, the US FDA announced major enhancements to the electronic Medical Device Reporting (eMDR) system, impacting all manufacturers required to…
- Medical Device Global Market Access
China NMPA Draft GMP Inspection Guideline: Risk-Based Audits and Critical Check Items
China's NMPA has released a draft 'Guideline for Inspection under the Medical Device Good Manufacturing Practices', signaling a major shift towards a…
- Medical Device Global Market Access
ANVISA Medical Device Regulation 2026: Brazil and Chile's Technical Exchange and Its Impact
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…
- Medical Device Global Market Access
ANVISA Technovigilance Changes in Brazil: What to Expect After the Public Consultation
This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework. We…
- Medical Device Global Market Access
South Korea Medical Device Act 2026: MFDS QMS and Distribution Rule Changes
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…
- Medical Device Global Market Access
Saudi Arabia SFDA Risk Communication Guidance: What MDS-G-029 Means for Manufacturers
The Saudi Food and Drug Authority (SFDA) published a new guidance, MDS-G-029, on July 9, 2026, establishing formal requirements for medical device risk…
- Medical Device Global Market Access
Health Canada Ministerial Reliance Order: Faster Market Access for Medical Devices
Health Canada has introduced a new Ministerial Reliance Order, effective July 15, 2026, designed to accelerate market access for medical devices and drugs…
- Medical Device Global Market Access
UK MHRA Draft Medical Device Regulations 2026: Key Changes and Timeline
This episode covers the closing of the WTO comment period on July 7, 2026, for the UK MHRA's draft Medical Devices (Amendment) Regulations 2026. We break down…
- Medical Device Global Market Access
EU REP Symbol Transition: Compliance Guide for Medical Device Labeling by 2031
This episode details the formal transition from the 'EC REP' to the 'EU REP' symbol for European Authorized Representatives on medical device and IVD labeling…
- Medical Device Global Market Access
Saudi Arabia SFDA Medical Device Bundling: Key Changes in Guidance MDS-G-028
Saudi Arabia's SFDA has released a new guidance document, MDS-G-028, effective May 3, 2026, which significantly changes the rules for bundling medical devices…
- Medical Device Global Market Access
Australia TGA UDI Requirements: High-Risk Device Compliance by July 1, 2026
Australia's Therapeutic Goods Administration (TGA) is implementing mandatory Unique Device Identification (UDI) requirements for high-risk medical devices…
- Medical Device Global Market Access
EU MDR Well-Established Technologies (WET) Exemption: New Rules for Class III and IIb Devices
The European Commission has significantly expanded the list of 'well-established technologies' (WET) under the EU Medical Devices Regulation (MDR) as of June…
- Medical Device Global Market Access
China NMPA BCI Classification Guidance: A New Framework for Neurotech Devices
China's National Medical Products Administration (NMPA) has released its first-ever "Guiding Principles for the Classification of Brain-Computer Interface…
- Medical Device Global Market Access
FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032
The US FDA has announced a public meeting on July 22, 2026, to discuss the proposed recommendations for the sixth reauthorization of the Medical Device User…
- Medical Device Global Market Access
Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting
On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA…
- Medical Device Global Market Access
Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices
Brazil's ANVISA has implemented a more flexible amendment process for its regulatory reliance pathway for high-risk medical devices under Normative Instruction…
- Medical Device Global Market Access
EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices
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)…
- Medical Device Global Market Access
China NMPA Innovative Device Approvals Accelerate: Market Access in 2026
China's NMPA is rapidly approving innovative medical devices, creating a major opportunity for global manufacturers. A new report reveals that 40 innovative…
- Medical Device Global Market Access
Australia's TGA UDI System: Preparing for the July 1, 2026 High-Risk Device Deadline
Australia's Therapeutic Goods Administration (TGA) is launching its Unique Device Identification (UDI) system, with the first major compliance deadline set for…
- Medical Device Global Market Access
Japan PMDA SaMD Guidance 2026: AI/ML, Cybersecurity, and Classification Changes
On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) issued a major update to its guidance for Software as a Medical Device (SaMD). This…
- Medical Device Global Market Access
India CDSCO Proposes Faster Medical Device License Timelines
India's Central Drugs Standard Control Organisation (CDSCO) has published a draft amendment to shorten the approval timelines for medical device manufacturing…
- Medical Device Global Market Access
South Korea Medical Device Act 2026: MFDS QMS and Distribution Changes
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…
- Medical Device Global Market Access
FDA AI Medical Device Draft Guidance 2026: Lifecycle Management and Submission Requirements
The FDA's June 6, 2026 draft guidance introduces significant new requirements for AI-enabled medical devices, focusing on total product lifecycle management…