Japan and South Korea offer significant opportunities for medical device manufacturers, but understanding local regulatory expectations is essential for developing an efficient market entry strategy.

In Japan, manufacturers may have existing biocompatibility data and reports. Understanding how these reports can be leveraged and what PMDA expects can help reduce unnecessary duplication and support a more efficient regulatory approach.

Meanwhile, South Korea is strengthening its regulatory framework for digital healthcare products, creating new considerations for manufacturers developing or commercializing digital medical devices and healthcare technologies.

In this webinar, Qualtech's regulatory specialists will provide a concise and practical overview of these developments, highlighting what medical device manufacturers should consider when preparing for market entry or regulatory submissions.

What You’ll Learn

• ▸ Japan: Key considerations for leveraging existing biocompatibility reports for PMDA
• ▸ South Korea: Understanding the Digital Healthcare Products Act and its impact on digital medical devices
• ▸ Market Access: Practical considerations for regulatory planning in both markets
• ▸ Interactive Q&A: Get answers to your regulatory questions from our experts

Whether you are exploring market entry, preparing a submission, or already operating in Japan or South Korea, this session will provide useful insights to help you navigate the evolving regulatory landscape.

Webinar Details

• ▸ Date: Thursday, September 17, 2026
• ▸ Time: 4:00 PM (GMT+8) | 10:00 AM (CET)
• ▸ Language: English
• ▸ Registration: https://us02web.zoom.us/webinar/register/WN_1nXqwoSPROanr_LE6jU1Kg

Reserve your spot and stay informed about the latest regulatory developments in Japan and South Korea.

Participants are welcome to submit questions through the registration form. Selected questions will be addressed during the live Q&A session.

For inquiries, please contact globalra@qualtechs.com.

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