• 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.

• 2026-05-22 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.

• 2026-04-28 08:14:56

The Medical Device Authority (MDA) has published the new guidance document, Application for Confirmation Status of Obsolete and Discontinued Medical Device (MDA/GD/0071). This publication was to assist establishments and healthcare professionals in understanding the applicable regulatory framework and in implementing appropriate control measures for obsolete and discontinued medical devices.

• 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.

• 2026-04-23 09:11:50

Singapore's Health Sciences Authority (HSA) has achieved the World Health Organization (WHO) Maturity Level 4 for medical device regulatory systems, the highest classification under WHO's global benchmarking framework. The recognition, announced on 10 March 2026 during the International Medical Device Regulators Forum (IMDRF) 29th session in Singapore, strengthens Singapore's position in global medical device regulation as a trusted reference authority for other regulators.

• 2026-04-23 08:41:55

Japan's orthopedic medical device market is drawing increasing global attention, supported by strong import activity and rising clinical demand. In 2023, orthopedic equipment accounted for the largest share of Japan's medical device imports at 14.9%, while orthopedic appliances alone reached US$2.67B in imports in 2024. With nearly 30% of the population aged 65 and above and more than 3.4M orthopedic procedures performed annually, Japan continues to see growing demand for advanced musculoskeletal solutions.

• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

• 2026-04-01 09:14:49

The proposed PFDA guidelines establish requirements for maintaining importation and distribution records and for reporting product complaints, adverse events, and field safety corrective actions for medical devices to ensure traceability and facilitate appropriate regulatory action. This article outlines the specific responsibilities, strict reporting timelines, and record-keeping mandates designed to protect public health throughout the device lifecycle.

• 2026-04-01 03:38:31

Following the latest release of the "Procedures for Changes to Raw Materials of Medical Devices", PMDA has provided a side notice with Frequently Asked Questions (FAQs) and concepts for specifying raw materials in applications. In this article, we have extracted several questions that foreign manufacturers may need to pay attention to.

• 2026-04-01 02:52:37

This webinar recap summarizes a session organized by Qualtech on key EU MDR developments in 2026, including updated transition deadlines, EUDAMED implementation, and new requirements for Notified Bodies, along with upcoming regulatory reforms aimed at improving efficiency, transparency, and innovation.