PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).

HONG KONG – India’s central government has finally placed most med-tech devices into the category of ‘drugs,’ subjecting them to control under the Drugs and Cosmetics Act, 1940.

HONG KONG – South Korea’s venture capital investment in the biopharma and medical sector set a new record in 2019. According to Korea Venture Capital Association (KVCA), local VC firms invested ₩1.1 trillion (US$930 million) over a total of 299 bio and medical ventures last year, representing 25.8% of the total VC investment executed in 2019.

BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour.

PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.

BOGOTA, Colombia – Medical supply manufacturers in Argentina have seen a surge in demand for their products from China, which is reaching out globally for the goods it needs to deal with the outbreak of COVID-19.

HONG KONG – The recent coronavirus (2019-nCov) scare has led to a rush of demand for masks that could soon strain pharmaceuticals and med-tech companies alike. In Hong Kong, queues for surgical masks now snake around the block.

HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours. The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd.

HONG KONG – Over the weekend, India’s Union Finance Minister Nirmala Sitharaman has imposed a health cess (also known as tax on tax) of 5% on the imports of medical equipment, except those exempted from basic customs duty (BCD). The aim of this development, stated in Sitharaman’s 2020 budget address, is to give impetus to the domestic industry and to generate resources for health services in the country.

HONG KONG – Singapore molecular diagnostics group Inex Innovate Pte. Ltd. has inked a deal to have its in-vitro diagnostic (IVD) kit for the detection of ovarian cancer distributed in Taiwan. The value of the deal with the New Taipei City, Taiwan-based electronics and med-tech distributor Inalways Corp. is subject to annual minimum order quantities and milestones in relation to regulatory approvals.