• 2026-06-26 06:37:19

Effective May 15, 2026, Decree No. 90/2026/ND-CP replaces Decree No. 117/2020/ND-CP, strengthening administrative sanctions and compliance control in Vietnam’s medical device sector. Non-compliance may result in higher fines, product circulation restrictions and temporary business suspension, which may affect supply chains and hospital tenders. To maintain smooth operations, companies are recommended to review classifications, verify localized labeling and align workflows with applicable regulatory timelines.

• 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.

• 2026-06-26 06:09:06

On 20 May 2026, HSA held a virtual industry briefing to present regulatory updates and support initiatives for medical devices and in vitro diagnostics (IVDs). The session covered revised guidance for software medical devices, updated Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0), audit reporting requirements, regulatory reliance with Malaysia's Medical Device Authority (MDA), reclassification of COVID‑19 IVDs, restructuring of IVD cluster grouping and a registration support initiative for unregistered devices.

• 2026-06-26 05:47:17

The Medical Device Authority (MDA) of Malaysia has published a new guidance document, Change Management for Registered Medical Devices (MDA/GD/0072). The guidance document will replace the current guidance document, Change Notification for Registered Medical Devices (MDA/GD/0020) and will be implemented following the official launch of MedCAST 3.0. Until such implementation takes effect, the current guidance document, MDA/GD/0020, shall remain applicable and in force.

• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 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.

• 2026-05-27 01:54:19

Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.

• 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 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.