This episode unpacks South Korea's pioneering Digital Medical Products Act (DMPA), set to revolutionize the regulatory landscape in January 2025. We explore the act's core components, including its new classification system for digital therapeutics and AI-driven software, the tailored approval processes, and what these changes mean for manufacturers seeking market access.

Key Questions:

• What is South Korea's new Digital Medical Products Act (DMPA)?

• Why is it considered the first comprehensive law of its kind globally?

• How does the DMPA classify different types of digital health products like AI and DTx?

• What new approval pathways will manufacturers need to navigate starting in 2025?

• How does the act support innovation for software-based medical devices?

• Are there different enforcement dates for different parts of the regulation?

• How does this new framework compare to regulations in the EU and the US?

• What immediate steps should your company take to prepare for this change?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

China's new electrical safety standard, GB 9706.1-2020, is now in effect, creating critical deadlines and new requirements for medical device manufacturers. This episode provides a detailed breakdown of the standard, outlining the key changes from the previous version, crucial implementation dates for new and existing products, and the significant impact on market access. We explore the new emphasis on risk management, essential performance, and what you need to do to ensure your devices remain compliant in one of the world's largest medical device markets.

Key Questions:

• What is the GB 9706.1-2020 standard and why is it critical for my device?

• When is the final deadline for my existing products to comply?

• How does the new standard differ from the old GB 9706.1-2007 version?

• What are the new requirements for "essential performance" and risk management?

• What happens if my device isn't compliant by the deadline?

• How do I find a qualified testing lab in China?

• What are the first steps I should take to begin the transition?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode provides a comprehensive overview of Australia's medical device regulations, governed by the Therapeutic Goods Administration (TGA). We explore the Therapeutic Goods (Medical Devices) Regulations 2002, detailing the risk-based classification system, the mandatory Essential Principles for safety and performance, the conformity assessment process, and the critical role of the Australian Register of Therapeutic Goods (ARTG) for market entry.

Key Questions:

• What is the TGA and what is its role in regulating medical devices in Australia?

• How does the Therapeutic Goods (Medical Devices) Regulations 2002 impact market entry?

• What are the different risk classifications for medical devices and why do they matter?

• What are the 'Essential Principles' that every device must meet for TGA approval?

• How do conformity assessment procedures differ for low-risk versus high-risk devices?

• What is the ARTG and why is it critical for selling your device in Australia?

• What are a manufacturer's post-market responsibilities after a device is approved?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode unpacks the crucial updates in Mexico's NOM-241-SSA1-2021, the mandatory standard for Good Manufacturing Practices for medical devices. We explore the enhanced Quality Management System (QMS) requirements, the formal inclusion of Software as a Medical Device (SaMD), and the significant decision by COFEPRIS to accept ISO 13485 and MDSAP certifications from foreign manufacturers, streamlining market access.

Key Questions:

• What is NOM-241-SSA1-2021 and when did it become mandatory for medical device manufacturers?

• How does the new standard change the definition of a medical device in Mexico?

• What are the core components of the newly emphasized Quality Management System?

• Does COFEPRIS now officially recognize ISO 13485 and MDSAP for GMP compliance?

• What does the update mean for software as a medical device (SaMD) manufacturers?

• How can foreign manufacturers streamline their path to compliance in Mexico?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode demystifies Argentina's medical device registration process under the national regulatory body, ANMAT. We provide a detailed breakdown of the essential framework established by Disposition 9688 of 2019, covering everything from risk classification and registration pathways to the critical requirements for foreign manufacturers seeking market entry.

Key Questions:

• What is ANMAT Disposition 9688/2019 and why is it essential for MedTech manufacturers?

• How does Argentina classify medical devices based on risk?

• What are the different registration pathways for Class I, II, III, and IV devices?

• Is it mandatory to appoint an Argentina Authorized Representative (AAR)?

• What are the Spanish language requirements for technical documentation?

• How long is a medical device registration valid in Argentina?

• Can an MDSAP certificate simplify my quality system compliance with ANMAT?

• What are the Good Manufacturing Practice (GMP) requirements for Argentina?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode provides a comprehensive guide to Colombia's medical device regulations, focusing on the foundational Decree 4725 of 2005 and the role of the regulatory body, INVIMA. We explore the four-tiered risk classification system, the detailed registration process for different device classes, the critical requirement of appointing a local representative, and the importance of post-market surveillance through the Tecnovigilancia program.

Key Questions:

• What is the foundational law for medical devices in Colombia and which agency enforces it?

• How does Colombia's risk classification system for medical devices compare to the EU's?

• Is a local representative in Colombia required to register a medical device?

• Can approval in the EU or US help speed up registration with INVIMA?

• For how long is a medical device registration valid in Colombia?

• Who should be the legal owner of the registration – the manufacturer or the distributor?

• What are the post-market surveillance requirements, known as Tecnovigilancia?

• In what language must all registration documents be submitted to INVIMA?

• Have there been any recent updates to the original 2005 decree?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode unpacks Brazil's landmark medical device regulation, RDC 751/2022. We explore the key updates that align Brazil with global standards, including the new risk classification rules, the shift to an IMDRF-based Technical Dossier, and critical transition deadlines for manufacturers.

Key Questions:

• What major changes does RDC 751/2022 introduce for MedTech companies?

• How do the new risk classification rules compare to the EU MDR?

• What is the "Table of Contents" format, and how does it affect your technical file?

• Did you meet the crucial February 29, 2024, deadline for up-classified devices?

• Are there new provisions for Software as a Medical Device (SaMD)?

• What are the updated labeling and Instructions for Use (IFU) requirements?

• How do the Notificação and Registro pathways differ under the new resolution?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode provides a dense overview of the EU Medical Device Regulation (MDR 2017/745), a pivotal shift in European MedTech compliance. We explore the regulation's core pillars, from its emphasis on a total product lifecycle approach and stricter clinical data requirements to the challenges of device reclassification, the Notified Body bottleneck, and new transparency measures like EUDAMED and the UDI system. It’s a crucial guide for any manufacturer navigating this complex landscape.

• What is the primary goal of Regulation (EU) 2017/745, the EU MDR?

• How does the MDR shift focus from pre-approval to a total lifecycle approach?

• Why are the new clinical evidence and Clinical Evaluation Report (CER) requirements so challenging?

• What is the "Notified Body bottleneck" and how does it impact market entry timelines?

• Are you aware of the extended transition deadlines and the critical dates from 2024?

• What roles do the EUDAMED database and UDI system play in the new framework?

• How does the MDR affect device classification and supply chain management?

• Does your organization have a designated Person Responsible for Regulatory Compliance (PRRC)?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing Notified Body oversight for most devices. This episode breaks down the fundamental changes, the expanded scope that now includes software and genetic tests, and the critical extended transition deadlines established in July 2024, providing manufacturers with a clear roadmap for compliance.

• What is the EU IVDR and how does it differ from the previous IVDD?

• What are the new risk classifications (A, B, C, D) for IVDs?

• How has the role of Notified Bodies changed under the new regulation?

• What are the latest extended transition deadlines for high, moderate, and low-risk IVDs?

• Are all IVD devices eligible for these extended deadlines?

• What are the specific conditions for a legacy device to qualify for the transition period?

• How does the IVDR affect medical device software and companion diagnostics?

• What happens if a manufacturer’s IVDD certificate expired before the new extension?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market entry. This episode provides a comprehensive overview of the Canadian Medical Devices Regulations, from its risk-based classification system to licensing, quality management, and post-market surveillance obligations for manufacturers and importers.

• What are the four risk classes for medical devices in Canada?

• What is the difference between a Medical Device Licence (MDL) and a Medical Device Establishment Licence (MDEL)?

• Which device classes require an MDL before being sold in Canada?

• What is the mandatory Quality Management System standard for Class II, III, and IV devices?

• How does the Medical Device Single Audit Program (MDSAP) fit into Canadian compliance?

• What are the bilingual labelling requirements for devices sold to the public?

• Who is responsible for mandatory incident reporting?

• What are the key post-market surveillance activities required under the CMDR?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.