Medical Device Global Market Access

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, who now have until April 1, 2027, to electronically link their actor registration (CHRN) to the devices they place on the market. This episode breaks down the new obligation, explains its dependency on prior device registration by manufacturers and Swiss Authorized Representatives (CH-REPs), and outlines practical steps for all economic operators to ensure compliance before the deadline.

Key Questions:
- What is the new importer linking function in Swissmedic's swissdamed database?
- When did this new requirement become active?
- What is the final deadline for Swiss importers to link devices?
- Why is collaboration with manufacturers and CH-REPs essential for compliance?
- What happens if a device is not registered by the manufacturer in swissdamed?
- How does this linking process affect the responsibilities of a Swiss importer?
- What practical steps should importers take now to prepare for the April 1, 2027 deadline?
- How does the UDI-DI play a role in this new process?
- What are the consequences of failing to link devices by the deadline?

Sources:
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance/importers.html
- https://www.medenvoy.com/resources/news/swissmedic-activates-swissdamed-importer-linking
- https://www.pure-global.com/insights/swissdamed-importer-links-by-1-april-2027/
- https://www.simone-ronco.com/en/blog/swissdamed-importers-linking-devices
- https://www.europe-it.com/blog/swissdamed-linking-of-udis/

How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts offer services like regulatory strategy, technical dossier preparation, and local representation in over 30 countries, including Switzerland. We can guide you through Swissmedic requirements, manage your swissdamed registrations, and ensure your quality systems are compliant. By combining local expertise with advanced AI, we streamline the entire process, from initial registration to post-market surveillance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI tools and regulatory database at https://pureglobal.ai.

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 Health Technology Assessment Regulation (HTAR). This episode explains what this pivotal moment means for medical device manufacturers, which device categories are impacted, and how the JCA will reshape the pathway for pricing, reimbursement, and market access across the European Union. We discuss the heightened evidence requirements and provide practical steps for regulatory and market access teams to prepare for this new centralized assessment system.

Key Questions:
- What is the EU Joint Clinical Assessment (JCA) and why is it critical for medical device manufacturers?
- Which types of high-risk medical devices were part of the first selection on October 6, 2026?
- How will the JCA report influence national reimbursement and pricing decisions?
- What is the difference between a CE marking submission and a JCA dossier?
- What are the new clinical evidence requirements under the Health Technology Assessment Regulation (HTAR)?
- How should companies adjust their clinical development strategies for future devices?
- What are the immediate actions regulatory teams should take to prepare for a JCA?
- When will the HTAR requirements expand to include other Class III and IIb devices?

Sources:
- https://health.ec.europa.eu/latest-updates/hta-regulation-commission-selects-first-medical-devices-joint-clinical-assessment-2026-10-06_en

How Pure Global can help:
Pure Global provides comprehensive support for MedTech and IVD companies navigating complex regulatory landscapes like the EU's new HTAR. Our experts develop robust regulatory and market access strategies, ensuring your clinical evidence meets the rigorous demands of Joint Clinical Assessments. We use advanced AI tools to efficiently compile and manage the technical dossiers required for both CE marking and JCA submissions, reducing time-to-market and compliance risks. With a presence in over 30 markets, we act as your local representative and provide continuous monitoring to keep you ahead of regulatory changes. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai to accelerate your global growth.

Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits. Effective October 1, 2026, these changes introduce a new fee model for design examinations based on Unique Product Identifier (UPI) components, increase certain recertification fees, and raise the minimum fee for subsequent devices in mandatory audits. This episode details what these changes mean for manufacturers and how to prepare your regulatory strategy and budget.

Key Questions:
- How is the TGA changing its fee reduction model for design examinations?
- What is the new fee reduction percentage for certain recertifications?
- By how much is the minimum fee increasing for related devices in a mandatory audit?
- When do these new TGA fee structures take effect?
- What are Unique Product Identifier (UPI) component assessments and how do they impact costs?
- Who is most affected by these changes to TGA conformity assessment fees?
- What practical steps should manufacturers take to prepare their regulatory budgets?
- How can sponsors strategically plan submissions under the new fee rules?

Sources:
- https://www.regconnect.medtech.org.au/september-28th-october-2nd-2026/

How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. For the Australian market, we offer local representation, develop efficient regulatory strategies for TGA submissions, and compile technical dossiers using advanced AI. Our team helps you navigate complex requirements like the TGA's updated fee structure to ensure compliant and cost-effective market entry and maintenance. We manage the entire lifecycle, from initial ARTG registration to post-market surveillance, ensuring your continued compliance. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Australia's Therapeutic Goods Administration (TGA) has clarified that many AI-powered digital scribes are considered medical devices, not simple administrative tools. Following a review published on October 16, 2023, the TGA found that 8 of 12 reviewed products were likely unapproved medical devices. This episode breaks down the TGA's reasoning, focusing on how a software's intended purpose—such as summarizing or analyzing clinical information—triggers regulatory oversight. We discuss the immediate compliance obligations for manufacturers and provide practical steps for developers of Software as a Medical Device (SaMD) to navigate this evolving regulatory landscape.

Key Questions:
- What did the TGA's review of AI digital scribes reveal on October 16, 2023?
- Why are some AI scribes now considered medical devices in Australia?
- What is the key difference between an administrative tool and a Software as a Medical Device (SaMD)?
- What immediate actions must manufacturers of unapproved AI scribes take?
- How does a product's intended purpose affect its regulatory classification?
- What are the steps for including an SaMD product in the Australian Register of Therapeutic Goods (ARTG)?
- What risks do developers face if they continue to supply non-compliant software?
- How can manufacturers conduct a gap analysis against TGA requirements?

Sources:
- https://www.racgp.org.au/newsgp/professional/ai-medical-scribes-face-stricter-tga-oversight
- https://www.tga.gov.au/news/news/digital-scribe-review-outcomes

How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. For SaMD developers targeting Australia, we offer expert regulatory strategy, technical dossier preparation for TGA submissions, and local representation services to ensure your product meets all compliance requirements. Our combination of local expertise and advanced AI tools streamlines the path to market, from initial classification to post-market surveillance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI-powered regulatory tools and global device database at https://pureglobal.ai.

On October 14, 2026, Japan's PMDA published its draft guidance, 'Review Points for Medical Devices Utilizing Generative AI.' This episode explores the key safety and performance evaluation criteria that manufacturers must understand to successfully bring advanced AI-enabled medical devices to the Japanese market. We cover the PMDA's expectations for data quality, AI model lifecycle management, transparency, and risk management, providing practical steps for regulatory and quality teams to prepare for these new requirements.

Key Questions:
- What are the main review points in Japan's new PMDA draft guidance for generative AI medical devices?
- How does this guidance impact manufacturers targeting the Japanese market?
- What does the PMDA expect for training data quality and management?
- How should companies address the risks of AI model drift and performance degradation?
- What are the new requirements for AI transparency and explainability?
- How can you adapt your risk management process for generative AI-specific hazards?
- What practical steps should your regulatory and quality teams take now?
- When was this important draft guidance released?

Sources:
- https://www.pmda.go.jp/english/whatsnew/default.html

How Pure Global can help:
Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts specialize in creating efficient regulatory strategies for novel technologies like AI-powered medical devices. We manage technical dossier preparation, submission, and local representation in over 30 countries, including Japan. By combining in-country expertise with advanced AI tools, we streamline the registration process, ensuring your innovative products meet complex requirements like the PMDA's new guidance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free regulatory AI tools and database at https://pureglobal.ai.