• 2026-07-27 03:42:33

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

• 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.

• 2026-07-27 02:32:02

The Hong Kong MDD has revised its Guidance Notes (GN-00), effective 13 May 2026. The update introduces Appendix 1, officially classifying injectable dermal and mucous membrane fillers as medical devices under MDACS. Manufacturers, LRPs, and consultants must evaluate this expansion due to immediate compliance and registration requirements.

• 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 05:40:00

South Korea has introduced amendments to both the Medical Device Act and the Regulation on Medical Device Approval, Notification, and Review, bringing important updates for manufacturers and importers. Key changes include expanded use of real-world evidence (RWE), simplified documentation requirements, a broader transition period for approved changes, and the establishment of a formal quality management system (QMS) conformity recognition framework. The amendments reflect South Korea's ongoing efforts to enhance regulatory efficiency, strengthen oversight, and support innovation in the medical device sector.

• 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 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.