• 2026-07-27 03:54:16

HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-06-26 06:49:48

Qualtech will be exhibiting at BIO Asia–Taiwan 2026, taking place from 16–19 July 2026 at the Taipei Nangang Exhibition Center, Taiwan. Visit us at Booth N1007 to connect with our regulatory and business development specialists and discuss medical device registration, regulatory compliance and market access opportunities across Asia Pacific.

• 2026-06-26 06:18:15

On 4 June 2026, the Taiwan Food and Drug Administration (TFDA) announced the Good Machine Learning Practice (GMLP): Development and Management Principles for Artificial Intelligence Medical Devices, providing a lifecycle management framework for AI-enabled medical devices. The guidance outlines 10 key principles covering product design, data quality, clinical evaluation, human oversight, cybersecurity, and post-market monitoring, while further aligning Taiwan's regulatory expectations with international AI medical device frameworks.

• 2026-05-28 01:39:58

Thai FDA has published the guideline for registration of custom-made dental medical devices, allowing manufacturers to rely on raw material technical evidence, rather than submitting finished product performance evidence for each individual custom-made device.

• 2026-05-22 06:47:10

The Medical Device Authority (MDA) of Malaysia and the Thailand Food and Drug Administration (Thai FDA) have officially announced the successful completion of a three-month pilot phase, which took place from 1 February 2026 to 30 April 2026. Following this pilot phase, the full implementation of the MDA–Thai FDA Medical Device Regulatory Reliance Programme will now apply to the registration of Class B, Class C, and Class D medical devices.

• 2026-05-26 08:23:40

Thailand's medical device industry is rapidly emerging as a prime destination for global investors, driven by strong local and regional demand, government support, and a robust regulatory framework. The sector’s growth is fueled by an aging population, increasing prevalence of non-communicable diseases, and a rebound in medical tourism. These factors, combined with Thailand's abundant raw materials and institutional support, position the country as a leading hub for medical device innovation and production.

• 2026-04-28 02:32:02

Thailand FDA's 2026 guidance introduces a more structured and risk-based approach to medical device change notifications. With expanded reporting scope and clearer classification pathways, companies should reassess internal change management processes to ensure timely compliance and avoid regulatory delays.

• 2026-04-28 02:04:20

The FDA has opened "Fast Track" channel for changes notifications for manufacturers of essential medical devices who face unavoidable supply chain disruptions in raw materials and packaging materials.
These changes notifications can be reviewed more rapidly by officials than standard change notification, to support manufacturers during the crisis.

• 2026-04-23 09:23:51

The Department of Infrastructure and Medical Devices will transition the domain of its online public service portal to https://vimda.moh.gov.vn effective April 1, 2026. The current domain will remain active until September 30, 2026, to ensure a smooth transition. Users are encouraged to switch to the new domain promptly.