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QUALTECH WEBINAR:  ENTERING JAPAN AND SOUTH KOREA: UNDERSTANDING PMDA AND MFDS REQUIREMENTS FOR MEDICAL DEVICES – SEPTEMBER 2025

QUALTECH WEBINAR: ENTERING JAPAN AND SOUTH KOREA: UNDERSTANDING PMDA AND MFDS REQUIREMENTS FOR MEDICAL DEVICES – SEPTEMBER 2025

  • 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.

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QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

  • 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.

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QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025

QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025

  • 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.

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QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

  • 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

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