• 2026-10-27 06:45:32

Australia's type 1 diabetes market presents opportunities for medical device companies, particularly in continuous glucose monitoring (CGM), as government subsidies support access to diabetes technologies. This article examines market growth, reimbursement arrangements and key Therapeutic Goods Administration (TGA) requirements, including Australian Register of Therapeutic Goods (ARTG) inclusion and unique device identification (UDI) compliance. It also explores opportunities across diabetes device categories and outlines practical considerations for companies planning to enter the Australian market.

• 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 05:30:31

Taiwan's Food and Drug Administration (TFDA) released new guidance in August and September 2026 for C-Reactive Protein (CRP) assays and Antimicrobial Susceptibility Testing (AST) systems, two Class II in vitro diagnostic (IVD) device categories. The updates require CRM470 calibration traceability and additional clinical data for hsCRP cardiovascular risk claims, as well as multi-center accuracy studies for AST systems. This analysis reviews the key changes, their impact on registration timelines and market competition, and the value of an early technical documentation gap analysis.

• 2026-10-27 05:15:40

Singapore's Health Sciences Authority (HSA) has introduced the submission window for the inaugural year of the Registration Support Initiative for unregistered medical device previously have been accessed through Special Access Routes (SAR) to 31 December 2026. This provides medical and dental practitioners and other stakeholders with additional time to prepare submissions, engage relevant parties and obtain the necessary endorsements. From 2027 onwards, the Initiative will follow a standard annual submission cycle from 1 October to 31 December.

• 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.

• 2026-10-27 04:18:58

The Food and Drug Administration of the Philippines (PFDA) has released a draft FDA Circular proposing detailed guidelines for medical device labeling in the Philippines. The draft provides more specific requirements on labeling content and placement, device-specific labeling, electronic labeling, and regulatory actions for non-compliance. It also proposes a two-year transition period for medical devices already registered and available in the Philippine market. While the Circular remains in draft form, it reflects PFDA's direction toward more detailed and specific medical device labeling requirements.

• 2026-10-26 09:52:44

The Food and Drug Administration of the Philippines (PFDA) has circulated a revised draft Circular proposing updated regulatory guidelines for Medical Device Software (MDSW), including AI-enabled MDSW. The draft outlines software qualification criteria, risk-based classification, product authorization pathways, and technical documentation requirements for initial and renewal applications. It also introduces AI-specific requirements covering clinical validation, cybersecurity, risk management, and post-market monitoring. The proposed guidelines aim to strengthen the safety and performance of MDSW throughout its lifecycle. The Circular remains in draft form and is not yet effective.

• 2026-10-26 09:33:44

The Ministry of Food and Drug Safety (MFDS) of South Korea has recently revised regulations concerning medical device adverse event reporting and Korean Good Manufacturing Practice (KGMP) and introduced a new regulation governing the designation and management of organizations involved in medical device quality management.
These regulatory updates aim to clarify adverse event reporting requirements and timelines, while improving regulatory clarity by separating KGMP conformity assessment requirements from provisions governing assessment bodies and training organizations.
This newsletter provides an overview of three regulatory updates that took effect on July 1 and September 22, 2026.

• 2026-10-26 09:17:04

This FAQ summarizes key regulatory resources and consultation opportunities relevant to the development and regulatory submission of Software as a Medical Device (SaMD) in Japan. The information is intended to support manufacturers in understanding regulatory expectations and planning efficient development and submission strategies throughout the product lifecycle.

• 2026-10-26 09:03:49

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.