• 2026-10-27 06:15:00

Qualtech's webinar on September 17, 2026 reviewed key regulatory developments for medical devices in Japan and South Korea. The Japan session covered how existing biocompatibility reports can support PMDA submissions, including JIS T 0993-1:2020 requirements, material documentation, GLP compliance and the acceptance of overseas test data. The South Korea session outlined the Digital Medical Products Act framework, covering device status determination, classification, regulatory pathways, K-GMP and post-market obligations.

• 2026-08-25 04:02:15

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

• 2026-04-23 07:36:58

The webinar hosted by Qualtech in March takes a closer look at how medical device studies are conducted in the United States. Covering US FDA classification, IDE and IRB pathways, and study design, it connects regulatory frameworks with their practical application in study execution. This recap highlights key considerations shaping how studies are structured and managed in the US context.

• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 2025-11-26 07:23:46

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

• 2025-11-10 07:33:05

Join Qualtech's upcoming webinar, "Southeast Asia Medical Device Compliance Update Series 2025 Part 2: Singapore, Malaysia & the Philippines", to gain valuable insights into three of ASEAN's most active and evolving medical device markets. This session will feature Qualtech's local regulatory experts, who will share the latest updates, policy trends, and compliance strategies across Singapore, Malaysia & the Philippines. Updates include current regulatory developments, harmonization efforts, and practical approaches to maintaining compliance while expanding in Southeast Asia.

• 2025-10-14 06:38:43

Join Qualtech's free webinar "Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam" on October 28, 2025, to gain practical insights into 3 of ASEAN's fastest-growing medical device markets. Learn about key regulatory updates, compliance strategies, and market opportunities directly from Qualtech's local regulatory experts. Stay informed, compliant, and ready for growth in Southeast Asia.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-08-15 01:48:59

On September 4th, join Qualtech for an insightful webinar, "Entering Japan and South Korea: Understanding PMDA and MFDS Requirements for Medical Devices". This session will offer practical guidance on navigating the regulatory systems of Japan and South Korea – ideal for companies seeking to accelerate market entry and avoid compliance-related issues.