• 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.

• 2026-09-23 03:31:24

Staying connected with the industry helps Qualtech keep its market knowledge current. Through our participation in CMEF Shanghai and BIO Asia–Taiwan 2026, we exchanged perspectives with manufacturers and industry professionals on market trends, regional expansion, and regulatory considerations across APAC.

• 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 08:32:41

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 07:35:09

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.

• 2026-07-27 04:05:50

Qualtech's recent webinar provided practical insights into medical device market entry in Australia and New Zealand, covering Australia's ARTG inclusion process, post-market obligations, new UDI requirements, and New Zealand's WAND notification framework. The session also highlighted key regulatory updates and practical considerations for manufacturers planning expansion into the ANZ market.

• 2026-07-27 02:32:02

The Hong Kong MDD has revised its Guidance Notes (GN-00), effective 13 May 2026. The update introduces Appendix 1, officially classifying injectable dermal and mucous membrane fillers as medical devices under MDACS. Manufacturers, LRPs, and consultants must evaluate this expansion due to immediate compliance and registration requirements.