• 2026-08-25 03:20:19

Australian Institute of Health and Welfare (AIHW) recorded 323,497 elective lens-intervention admissions in 2024-25, with private hospitals accounting for 71.9% of recorded activity. With 98% of cataract surgeries delivered as same-day procedures and US$121.9M of ophthalmic instrument imports in 2025, the market combines substantial procedure activity with an established international supply channel. For global manufacturers, successful entry requires product-specific ARTG, sponsorship and UDI planning.

• 2025-10-27 04:49:01

To simplify preparation and expedite event organization, the Thai FDA announced that no advertising license is required for presenting medical devices at national, or international academic exhibitions and conferences. Academic events that meet the specified conditions may qualify for this exemption.

• 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 2022-09-27 09:03:07

The pandemic has exposed supply chain vulnerabilities and issues in the medical device supply chain that were once insignificant. In this article, we compile the industry’s best practices towards achieving sustainability and resilience in the medical supply chain.

• 2022-06-29 01:41:00

The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).

• 2022-05-31 02:38:03

The COVID-19 epidemic has undoubtedly boosted the healthcare industry digitization worldwide. Personal medicine, telemedicine, genomics, and wearables are predicted to increase significantly over the next half decade thanks to artificial intelligence (AI), extended reality (XR), cloud computing, and the internet of things (IoT). In the face of this trend, there are several opportunities and problems particular to the Asian medical device industry. In this article, we examine the general situation of the Asian medical device industry as well as the Chinese, Japanese, and ASEAN markets in further detail.

• 2022-04-27 11:34:25

The US FDA is classifying the interoperable automated glycemic controller into class II. Also, the codified language for the interoperable automated glycemic controller is taken as a part of the device to the special control.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.

• 2021-03-22 02:43:02

Health Sciences Authority (HSA) launched Pandemic Special Access Route (PSAR) for important therapeutic products essential for pandemic response. HSA defined the group of products that can apply via this route and the requirements/criteria for submission.