Podcast Episodes
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From Europe to Japan: Leveraging Your CE Mark for PMDA Approval
Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requ…
1 year, 1 month ago
From Europe to Brazil: Bridging the CE Mark and ANVISA Gap
This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between E…
1 year, 1 month ago
From MDR to NMPA: A Strategic Guide to China Market Entry
This episode details the strategic process for transitioning a medical device with a European CE mark under MDR to achieve Class II or III registrati…
1 year, 1 month ago
Unlocking the Canadian MedTech Market: Beyond the CE Mark
This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for sel…
1 year, 1 month ago
From CE to UKCA: Navigating the UK Medical Device Transition
This episode breaks down the essential steps for medical device manufacturers with a CE mark to comply with UK regulations for Great Britain. We cove…
1 year, 1 month ago
Cracking the Code: Japan's PMD Act & QMS Requirements
This episode provides a focused guide to Japan's medical device regulations. We explore the relationship between the overarching PMD Act and the deta…
1 year, 1 month ago
China's Regulatory Overhaul: Your Guide to NMPA Order 739
This episode delves into the landmark revision of China's medical device regulations, State Council Order No. 739, which took effect on June 1, 2021.…
1 year, 1 month ago
Unlocking the Indian Market: A Guide to the 2017 and 2023 Device Rules
This episode provides a deep dive into India's Medical Device Rules, 2017, and the subsequent amendments through 2023. We explore the shift to a risk…
1 year, 1 month ago
South Korea's Game-Changing 2025 Digital Medical Products Act
This episode unpacks South Korea's pioneering Digital Medical Products Act (DMPA), set to revolutionize the regulatory landscape in January 2025. We …
1 year, 1 month ago
China's New Electrical Safety Standard: Navigating the GB 9706.1-2020 Transition
China's new electrical safety standard, GB 9706.1-2020, is now in effect, creating critical deadlines and new requirements for medical device manufac…
1 year, 1 month ago