• 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.

• 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(GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.

• 2025-10-27 02:31:38

PMDA released a notification for the medical industry to reference the "Practical Guide for Radio Wave Management of Medical Telemetry Devices", prepared and released by the Electromagnetic Compatibility Conference Japan (EMCC). The purpose of the guide is to provide operational guidelines for radio management of medical telemeter systems (wireless physiological monitoring devices used in hospitals and healthcare facilities), ensuring interference prevention, safety, and proper use. In addition, the guide is intended to promote the development and utilization of practical manuals tailored to individual user groups, such as nurses, clinical engineers, and hospital administrators or administrative staffs.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

• 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

• 2024-06-20 05:41:18

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.