• 2025-09-24 10:06:53

Malaysia has emerged as a dental powerhouse, attracting international patients with world-class treatments at affordable prices, while fueling one of ASEAN's fastest-growing dental device markets. With over 3,700 private clinics and a nationwide network of public facilities, the country is well-positioned to meet rising demand driven by medical tourism and a tech-savvy private sector. Yet, Malaysia also faces a domestic oral health challenge, highlighting both the urgency and the opportunity for innovation.

• 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.

• 2025-09-24 08:47:47

The Ministry of Food and Drug Safety (MFDS) has announced amendments to both the Enforcement Rules of the Medical Device Act and the Medical Device Standards. The revisions, implemented between April and August 2025, included higher fees for innovative medical device reviews, exemptions from documentation requirements, stricter administrative sanctions, and the establishment of long-term follow-up requirements. In addition, amendments to the Medical Device Standards have been finalized and are scheduled to take effect in July 2026, introducing new standards and aligning existing ones with international norms.

• 2025-09-24 08:22:59

The Medica Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme to streamline approvals for Class B–D devices. The main purpose are to fast-track market access, cutting cost, reducing duplication and enhanced patient care.

• 2025-09-24 07:40:52

PMDA has revised the approach to biological safety evaluation and abolished the previous notification issued on Jan 6, 2020. The revised approach focuses on providing practical instructions for preparing regulatory submissions.

• 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The FDA has issued draft guidance on marketing submissions for AI-enabled device software functions (AI-DSFs), with a focus on using a predetermined change control plan (PCCP).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.

• 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!​

• 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.