• 2026-01-30 06:02:05

Vietnam faces a surge in respiratory diseases, primarily COPD and asthma. Heavy reliance on imported medical equipment exacerbates the issue. The government's Healthy Lung Program offers hope, but increased demand for respiratory devices creates a market opportunity.

• 2026-01-30 07:13:08

Thailand has updated its medical device labeling and IFU regulation, which will take effect on June 20, 2026. The new regulations expand the scope to include Software as Medical Device (SaMD), reusable surgical and dental instruments, and medical device accessories. Manufacturers and Importers are granted transition period until June 20, 2028, to transition from the 2020 requirements to the new 2025 requirements. Medical device companies marketing products in Thailand must update their labeling and IFU to comply with this updated announcement by the enforcement deadline.

• 2026-01-30 05:41:43

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore's Health Sciences Authority (HSA) have created a first‑of‑its‑kind Regulatory Innovation Corridor, launched on 12 December 2025. This coordinated fast‑track pathway allows developers of breakthrough medicines and medical devices to engage both regulators simultaneously. By offering coordinated feedback early in development, it seeks to streamline clinical trials, reduce duplication and accelerate patient access to promising therapies in areas such as cancer, dementia, obesity, rare diseases and advanced diagnostics. Further detail on the new fast track pathway have not yet been published by HSA.

• 2026-01-30 04:39:59

Recently, in the tempu bunsho (Japanese approved IFU) of pharmaceuticals containing hydroxycarbamide as the active ingredient, a warning was issued that, when taking this drug, glucose measurement results may show values higher than the actual glucose level (false high values).
Accordingly, similar warnings should also be included in the tempu bunsho of blood glucose measuring devices. Therefore, for blood glucose measuring devices using the enzyme electrode method, a voluntary review of the tempu bunsho should be conducted, and, if necessary, revisions and dissemination of information to should be implemented.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.

• 2026-01-30 04:16:17

NMPA released the 2025 Catalog of High-End Medical Devices for Priority Approval to expedite the registration process for innovative high-end medical devices.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2026-01-20 03:48:00

Join Qualtech's free webinar "Expert Insights - EU MDR Updates 2026" on February 12, 2026, to gain practical insights and stay up to date with the most recent developments in the European Medical Device Regulation. This session will assist you and your organization to confidently navigate EU MDR requirements and prepare for the end of the transition period. Stay informed, stay compliant, and turn MDR challenges into opportunities.

• 2025-12-26 04:30:43

The Indonesian medical aesthetics market is projected to grow significantly, reaching is it USD 450.23 million by 2028, driven by increasing awareness and demand for cosmetic procedures. Key market drivers include advanced cosmetic technologies, a growing middle-class population, and supportive government policies. However, challenges such as regulatory constraints and high procedural costs remain.

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.