• 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.

• 2026-09-21 02:28:25

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.

• 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.

• 2026-08-25 08:37:14

Thailand has updated its operational framework for Class 2-4 medical device change notification. Revised processing timelines and fee structures have been established for both standard and expert review pathways. Medical device manufacturers and importers marketing products in Thailand must review the updated criteria, evaluation periods, and associated fees prior to submitting change requests to ensure full regulatory compliance.

• 2026-08-25 08:32:41

Singapore's Health Sciences Authority (HSA) has extended the compliance date for Phase 3 implementation of Unique Device Identification (UDI) requirements from 1 November 2026 to 31 December 2026. Class C General medical devices and in vitro diagnostic (IVD) medical devices must therefore carry UDI labelling prior to import and supply in Singapore from 1 January 2027.

• 2026-08-25 07:50:09

The Medical Device Authority (MDA) of Malaysia has announced the new Automated Re-Registration Route within the MeDC@St 2.0+ platform, effective from 13 July 2026. This initiative aims to support continuous product availability, reducing administrative workload, and improving regulatory efficiency while maintaining compliance with existing MDA requirements.

• 2026-08-25 07:35:09

The Ministry of Health Malaysia (MOH) will gradually implement a Hologram Security Label for registered medical devices to help identify genuine, registered products with the Medical Device Authority (MDA) and prevent the sale of counterfeit and unregistered devices. The official announcement is scheduled to be made during IMDEC 2026 event on 26 August 2026.

• 2026-08-25 07:11:00

As general-purpose digital devices like smartphones and wearables become increasingly integrated into health monitoring, PMDA published the review guidance for home-use Software as a Medical Device (SaMD) intended to detect signs of disease and encourage users to seek medical consultation. It outlines the scope of the guidance, product description requirements, evaluation dossier, and key considerations for clinical study design, including clinical intention, design concept, clinical performance evaluation, and risk management. The summary is intended to provide an overview of the regulatory expectations for the development and evaluation of this type of SaMD and to facilitate understanding of the PMDA review approach.

• 2026-08-25 04:50:05

Indonesia's medical device regulatory framework places increasing emphasis on demonstrating compliance with applicable healthcare standards through appropriate testing and validation. Manufacturers and applicants should ensure that the required test results, validation documents, and supporting certifications are available as part of the product registration and compliance process. Recent requirements highlighted for in vitro diagnostic products (IVDs) include specific provisions for performance testing, instrument connectivity, and software validation.

• 2026-08-25 04:38:17

The Hong Kong Department of Health (DH), through its Medical Device Division (MDD), has established the "Novo Lane" under the Medical Device Administrative Control System (MDACS) to prioritize the processing of eligible innovative medical device listing applications. The initiative is intended to facilitate earlier access to innovative medical technologies while maintaining regulatory oversight of medical device safety and performance. As part of its regulatory approach, the MDD continues to monitor the safety and performance of listed medical devices after they are placed on the market.