• 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.

• 2025-08-25 07:56:48

On July 21, 2025, Qualtech hosted a webinar featuring Mobius Medical's Co-Founder and Clinical Director, Stefan Czyniewski, on "Accelerating Innovation: Why Australia Is the Ideal Partner for Your Next Clinical Trial". The session emphasized Australia’s speed and cost-efficiency under the Clinical Trial Notification (CTN) scheme, world-class infrastructure, and broad international acceptance of trial data. Key comparisons with the United States highlighted faster start-up timelines, simpler regulatory pathways, and substantial financial incentives such as the R&D Tax Rebate. With its favorable environment for early-phase medical device and diagnostic studies, Australia stands out as a strategic launchpad for global clinical development.

• 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.

• 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

• 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

• 2025-05-06 08:38:10

Stay ahead in China's evolving medical device regulations! Join our FREE webinar to master NMPA registration, technical reviews, and post-market compliance. Gain expert strategies to accelerate approvals and avoid risks—whether entering the market or optimizing compliance. Secure your spot now!

• 2025-04-24 09:48:40

On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.

• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2025-03-10 02:22:15

Join Qualtech's webinar on March 26, 2025, for key insights into Australia's medical device market and TGA regulations. Learn about the registration process, Sponsor responsibilities, post-market requirements, and get answers to common questions. Register now here to secure your spot!