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Qualtech Webinar: Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam – October 2025

Qualtech Webinar: Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam – October 2025

  • 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.

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QT ACTIVITY: Entering Japan & South Korea – Understanding PMDA & MFDS Requirements for Medical Devices WEBINAR RECAP - AUGUST/SEPTEMBER 2025

QT ACTIVITY: Entering Japan & South Korea – Understanding PMDA & MFDS Requirements for Medical Devices WEBINAR RECAP - AUGUST/SEPTEMBER 2025

  • 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.

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USA: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - August/September 2025

USA: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - August/September 2025

  • 2025-09-24 07:20:49

The FDA has issued draft guidance on marketing submissions for AI-enabled device software functions (AI-DSFs), with a focus on using a predetermined change control plan (PCCP). A PCCP allows manufacturers to plan and manage software changes in a predictable and controlled way, making regulatory review smoother and device performance more reliable.

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Qualtech Will Attend the 46th Beijing International Medical Devices Exhibition​ - September 2025

Qualtech Will Attend the 46th Beijing International Medical Devices Exhibition​ - September 2025

  • 2025-09-12 04:37:38

Qualtech will participate in the 46th Beijing International Medical Devices Exhibition on September 17–19, 2025. As one of China's premier MedTech events, the exhibition offers a key platform for engaging with healthcare stakeholders and exploring regional opportunities. Our team will be on-site to provide guidance on regulatory strategy and market access across APAC region.

Book a 1-on-1 session to meet us at the event!​

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QT ACTIVITY: WHY AUSTRALIA IS THE IDEAL PARTNER FOR YOUR NEXT CLINICAL TRIAL WEBINAR RECAP - JULY/AUGUST 2025

QT ACTIVITY: WHY AUSTRALIA IS THE IDEAL PARTNER FOR YOUR NEXT CLINICAL TRIAL WEBINAR RECAP - JULY/AUGUST 2025

  • 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.

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CHINA: Announcement of the National Medical Products Administration on Measures to Optimize Whole-Lifecycle Regulation to Support the Innovative Development of High-End Medical Devices (No. 63 of 2025) – JULY/AUGUST 2025

CHINA: Announcement of the National Medical Products Administration on Measures to Optimize Whole-Lifecycle Regulation to Support the Innovative Development of High-End Medical Devices (No. 63 of 2025) – JULY/AUGUST 2025

  • 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

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INDONESIA: THE DECISION OF THE MINISTER OF HEALTH NO HK.01.07/MENKES/736/2025 – ON MEDICAL DEVICES THAT CAN BE SOLD BY RETAIL BUSINESS OPERATORS – JULY/AUGUST 2025

INDONESIA: THE DECISION OF THE MINISTER OF HEALTH NO HK.01.07/MENKES/736/2025 – ON MEDICAL DEVICES THAT CAN BE SOLD BY RETAIL BUSINESS OPERATORS – JULY/AUGUST 2025

  • 2025-08-25 03:07:39

Indonesia's Ministry of Health has issued Decision Letter No. HK.01.07/MENKES/736/2025, which outlines the types of medical devices that may be sold by retail business operators. This regulation clarifies the criteria that these devices must meet and the obligations that retailers must follow when engaging in the sale of medical device. It also provides a reference list of medical devices that are eligible for retail distribution under this policy.

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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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