This episode demystifies the process of obtaining medical device approval in Japan for companies that already have FDA clearance. We explore the critical differences between the two systems and outline the essential steps manufacturers must take, from appointing a local representative to preparing a Japan-specific submission dossier and navigating clinical data requirements for either Shonin or Ninsho approval.

Key Questions:

• Does FDA clearance guarantee market access in Japan?

• What is a Marketing Authorization Holder (MAH) and why is it essential?

• How does Japan's device classification system determine the approval pathway?

• What is the difference between "Shonin" approval and "Ninsho" certification?

• Is an ISO 13485-compliant QMS sufficient for Japan's Ordinance 169?

• Will the Japanese PMDA accept clinical trial data from the United States?

• What is the Summary Technical Documentation (STED) format?

• How can manufacturers proactively address potential hurdles in the Japanese review process?

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 the process for medical device manufacturers who have U.S. FDA approval and are targeting the Indian market. We clarify that while FDA registration is beneficial, it does not replace the mandatory import license from India's Central Drugs Standard Control Organization (CDSCO). We outline the essential steps, including appointing an Authorized Indian Agent, understanding India's risk-based device classification, and preparing the required Device and Plant Master Files for a successful submission.

Key Questions:

• Does having U.S. FDA approval mean you can automatically sell your medical device in India?

• What is the role of the Central Drugs Standard Control Organization (CDSCO)?

• What are the mandatory first steps for a foreign manufacturer to enter the Indian market?

• Is an Authorized Indian Agent required, and what are their responsibilities?

• What are the Device Master File (DMF) and Plant Master File (PMF)?

• How does India classify medical devices, and why does it matter?

• What is the typical timeline for obtaining an import license in India?

• What critical regulatory deadline passed on October 1, 2023?

• How does your existing FDA documentation support your CDSCO application?

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 explores the process for medical device manufacturers to enter the South Korean market after receiving FDA approval. We delve into the specifics of the Ministry of Food and Drug Safety (MFDS) requirements, comparing its risk-based classification and submission pathways to the U.S. system. The discussion focuses on the practical steps for leveraging existing FDA testing data, the critical need for Korea Good Manufacturing Practice (KGMP) certification, and the role of a local Korea License Holder (KLH).

Key Questions:

• How does South Korea's four-class risk system for medical devices compare to the FDA's?

• Can performance and clinical data from an FDA submission be used for MFDS approval?

• What are the three distinct regulatory submission pathways in South Korea?

• Is an ISO 13485 certificate sufficient for quality system compliance in Korea?

• What is a Korea Good Manufacturing Practice (KGMP) certificate and why is it essential?

• What is a Summary Technical Documentation (STED) file and when is it required?

• Do foreign companies need a local representative to register devices in South Korea?

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 the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices. We explore how this process-oriented standard is critical not just for user satisfaction, but for ensuring patient safety by minimizing use-related risks. Learn about the key phases, from defining use specifications and conducting formative evaluations to performing final summative validation, all of which are essential for securing market access in key regions like the US and EU.

• What is usability engineering and why is it about safety, not just user-friendliness?

• How does IEC 62366-1:2015 integrate with the ISO 14971 risk management process?

• What is the critical difference between formative and summative evaluations?

• Why is a Usability Engineering File a required component of your regulatory submission?

• How can non-compliance with this standard block your device from global markets?

• What are "hazard-related use scenarios" and why are they vital for testing?

• How do you properly define user profiles and use environments?

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 delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why compliance is no longer optional but a strategic advantage.

Key Questions:

• What is IEC 81001-5-1 and why was it created?

• How does this standard change the approach to software development and maintenance?

• Does this standard apply only to medical devices, or is the scope broader?

• What are the core requirements, from threat modeling to post-market surveillance?

• How does the standard build upon existing frameworks like IEC 62304?

• What is the regulatory status of IEC 81001-5-1 in the EU and the US?

• Why is compliance becoming a non-negotiable for global market access?

• What are the risks of ignoring this new cybersecurity benchmark?

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 the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements of five different countries. We explore its history, the participating authorities, the benefits for manufacturers—including reduced audit fatigue and faster market access—and how the program streamlines global compliance.

• What is the Medical Device Single Audit Program (MDSAP)?

• Which five major global markets can you access with a single audit?

• How does MDSAP reduce audit fatigue and save resources for manufacturers?

• What makes MDSAP a mandatory requirement for selling medical devices in Canada?

• How can one audit report substitute for a routine FDA inspection?

• What is the role of an Auditing Organization (AO) in the MDSAP process?

• Which international body initiated the MDSAP program in 2012?

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 details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therapeutic Goods (ARTG). We explore how leveraging your existing FDA approval can streamline the TGA inclusion process, the critical role of an Australian Sponsor, and the importance of recent regulatory updates effective in late 2024.

• Is my FDA clearance automatically accepted in Australia?

• What is the very first step for a foreign manufacturer to enter the Australian market?

• Which specific FDA documents does the TGA accept as evidence?

• What is an Australian Declaration of Conformity and is it required?

• Do I need a new Quality Management System certificate for Australia?

• How can I use my existing clinical data for the TGA application?

• What is the key regulatory change happening on October 19, 2024?

• What are my responsibilities after my device is listed on the ARTG?

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.

Holding FDA PMA approval is a significant achievement, but what does it mean for entering the Canadian market? This episode breaks down the essential steps and requirements for obtaining a Health Canada Medical Device Licence for your high-risk device. We explore how to leverage your existing FDA data while navigating Canada's unique regulatory landscape.

• Does FDA PMA guarantee a Health Canada licence?

• What are the Canadian device classifications for high-risk products?

• Is an FDA-compliant QMS enough for Health Canada?

• What is the Medical Device Single Audit Program (MDSAP) and why is it critical?

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

• Can my FDA submission documents be used for a Health Canada application?

• What specific formatting does Health Canada require for submissions?

• Are there unique labelling requirements for the Canadian market?

• How have regulations changed since the 2016 notice on using FDA guidance?

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.

Think your FDA 510(k) is a fast track to a European CE Mark? This episode uncovers the critical gaps between the two regulatory systems. We explore the fundamental differences in philosophy, from the FDA's "substantial equivalence" model to the EU MDR's lifecycle approach, and detail the extra work required in quality management, clinical evidence, technical documentation, and post-market surveillance to achieve compliance in Europe.

Key Questions:

• Is a 510(k) clearance a shortcut to getting an EU MDR CE Mark?

• How do the Quality Management System (QMS) requirements for the FDA and EU differ?

• Why isn't the data for my 510(k) enough for a European Clinical Evaluation Report (CER)?

• What are the General Safety and Performance Requirements (GSPRs) and why are they crucial for my EU Technical File?

• How does the EU's proactive Post-Market Surveillance (PMS) system compare to the FDA's requirements?

• What is a Notified Body, and why is their pre-market audit essential for European market access?

• What is a Periodic Safety Update Report (PSUR) and will my device require one?

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 breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the De Novo is a powerful asset, it does not grant automatic approval. We cover the essential steps, from determining your device's risk classification under Brazilian regulations to understanding the different registration pathways (*Notificação* vs. *Registro*), the mandatory requirement of a Brazil Registration Holder (BRH), and the importance of compiling a technical dossier using your existing FDA data.

• Does an FDA De Novo grant guarantee ANVISA approval in Brazil?

• What is the most critical first step when seeking Brazilian market access?

• How does Brazil's risk classification system differ from the FDA's?

• What is the difference between the *Notificação* and *Registro* pathways?

• Is it possible to register a device in Brazil without a local office?

• What is a Brazil Registration Holder (BRH) and why are they essential?

• How can the data from my De Novo submission accelerate ANVISA registration?

• What are INMETRO and ANATEL certifications, and does my device need them?

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.