• 2026-10-27 06:15:00

Qualtech's webinar on September 17, 2026 reviewed key regulatory developments for medical devices in Japan and South Korea. The Japan session covered how existing biocompatibility reports can support PMDA submissions, including JIS T 0993-1:2020 requirements, material documentation, GLP compliance and the acceptance of overseas test data. The South Korea session outlined the Digital Medical Products Act framework, covering device status determination, classification, regulatory pathways, K-GMP and post-market obligations.

• 2026-10-27 04:39:09

Singapore's Health Sciences Authority (HSA) has published the finalised GL-10 R1 Best Practices Guide on Medical Device Cybersecurity following a public consultation conducted from 10 March to 13 May 2025. The guide provides best practice recommendations and considerations for managing cybersecurity risks associated with connected medical devices throughout the Total Product Life Cycle (TPLC). HSA also published a summary of responses to stakeholder feedback received during the consultation.

• 2026-09-21 03:23:41

The Philippine Department of Health has released a proposed Administrative Order establishing Good Manufacturing Practice (GMP) guidelines for local medical device and IVD medical device manufacturers. The proposed Order adopts PNS ISO 13485:2019 as the Food and Drug Administration (FDA)'s official GMP guideline and applicable PNS ISO 14644 standards for clean rooms. A two-year transitory period is proposed to allow affected manufacturers to comply with the new requirements once the Order takes effect.

• 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 06:18:15

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 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.

• 2026-04-23 07:36:58

The webinar hosted by Qualtech in March takes a closer look at how medical device studies are conducted in the United States. Covering US FDA classification, IDE and IRB pathways, and study design, it connects regulatory frameworks with their practical application in study execution. This recap highlights key considerations shaping how studies are structured and managed in the US context.

• 2026-02-25 04:43:48

Thai FDA has provided recommendations on applicable international standards for particular types of active medical devices to support medical device registration in Thailand. These standards are presented as advisory references only and are intended to assist the registrants in preparing relevant test reports in accordance with the ASEAN Common Submission Template Dossier (CSDT).

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 2025-12-26 03:21:16

On November 4, 2025, the NMPA released the revised Good Manufacturing Practice for Medical Devices (GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.