• 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.

• 2026-10-26 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.

• 2026-10-09 01:44:32

Qualtech invites you to our free webinar on Thursday, October 29, 2026, with the topic "ASEAN Regulatory Briefing: Thailand & Malaysia - Critical Updates Impacting Medical Device Market Access".
Our local regulatory experts from Thailand and Malaysia will share practical insights into the latest regulatory changes, updated requirements, and key considerations affecting medical device registration and regulatory compliance. This session is highly recommended for all medical device manufacturers currently active in, or planning to enter, the Thailand and Malaysian market.

• 2026-09-21 03:51:16

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

• 2026-09-21 02:42:09

The Department of Health (DH) of Hong Kong issued a letter regarding the updated regulatory requirements for the use of injectable and infusible product in licensed Private Healthcare Facilities (PHFs) which cover pharmaceutical products, human organ/human tissue product, and medical device. For medical devices, the DH has announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the MDACS, effective 1 March 2027. This new requirement specifically includes injectable dermal fillers and injectable mucous membrane fillers.

• 2026-08-25 04:02:15

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

• 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.