PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.

HONG KONG – Singapore-based Igene Laboratory, a wholly owned subsidiary of Inex Innovate Pte. Ltd., has launched a noninvasive prenatal test (NIPT) that assesses fetal Rhesus factor (RhD) status from a maternal blood sample.

HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.

HONG KONG – China and U.S.-based Lisen Imprinting Diagnostics Inc. has unveiled its Quantitative Chromogenic Imprinted Gene In-Situ Hybridization (QCIGISH) technology, a novel approach for identifying, visualizing and quantifying the biallelic and multiallelic expressions of an imprinted gene panel associated with cancer status.

HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.

PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.

HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently.