• 2025-08-25 08:41:48

Australia's aesthetic market is entering a high-growth phase, with nearly 7 million adults considering cosmetic surgery and industry value projected at US$1.5 billion in 2024. Strong demand for injectables and advanced devices, supported by new national standards, offers aesthetic medical device manufacturers strong potential to introduce innovative solutions and capture growth in this dynamic market.

• 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.

• 2025-08-25 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.

• 2025-08-25 05:57:23

Thai FDA has announced a significant update to the renewal process for Class 2, 3, 4 medical device certificates, effective from 22 July 2025. This reform introduces streamlined procedures, with automatic renewals for full CSDT dossiers and differentiated requirements for Partial pathway registrations. By reducing unnecessary document submissions, the Thai FDA aims to balance regulatory efficiency with patient safety.

• 2025-08-25 05:37:56

Thai FDA has recently introduced an optimized process for certain medical device advertisements, allowing specific categories of promotional content to be automatically approved. The framework accelerates market communication while maintaining compliance.

• 2025-08-25 04:38:43

The Minister of Finance promulgated Circular 64 /2025/TT-BTC dated June 30, 2025, which lowered fees to alleviate difficulties and support production and business activities.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 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.

• 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.

• 2025-07-10 08:37:53

During Medical Taiwan 2025, Qualtech engaged with manufacturers and distributors seeking trusted support for regulatory navigation and market expansion across the APAC region. With growing opportunities throughout this dynamic market, Qualtech continues to serve as a trusted partner for global medical device manufacturers expanding across Asia.