• 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.

• 2026-05-22 02:22:56

As EU MDR expectations continue to intensify in 2026, manufacturers are facing greater scrutiny across technical documentation, clinical evidence, and lifecycle compliance. Qualtech's webinar recap highlights practical insights on MDR transition planning, Annex XVI obligations, notified body expectations, and key compliance priorities shaping EU market access strategies.

• 2026-04-28 08:33:22

The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).

• 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.

• 2026-04-28 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.

• 2026-04-28 01:22:14

In alignment with the latest regulatory guidance on SaMD and cybersecurity for network-connected devices, the framework for managing ancillary network infrastructure (such as VPN gateways) has been refined. This includes an extensive definition of responsible matrices, lifecycle security maintenance, and the implementation of proactive security controls to mitigate cyber risks.

• 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.