Recently, the Australian Medical Device Regulatory Authority (TGA) issued a statement announcing that the transition period for ISO 13485 certificates as evidence for manufacturers of in vitro diagnostic (IVD) medical devices has ended on May 26, 2023.

As everyone knows, not long ago the TGA announced that it will no longer accept applications for ISO 13485 certificates to support new in vitro diagnostic (IVD) medical devices, unless the manufacturer has made compliance with the EU IVD Directive before May 26, 2022. statement.

Purpose of drafting: To standardize the classification management of in vitro diagnostic reagents, to guide the formulation and adjustment of the classification catalog of in vitro diagnostic reagents, and to determine the management categories of new in vitro diagnostic reagents.Management category: In vitro diagnostic reagents are divided into the first category, the second category and the third category according to the degree of risk from low to high.

Medical technology, drugs, and medical devices are the three pillars of the medical service system. Medical devices involve sound, light, electricity, magnetism, imaging, materials, mechanics and other industries and nearly a hundred professional disciplines. It is an internationally recognized high-tech industry. It has the characteristics of high-tech intensiveness, extensive cross-discipline, and technological integration, which represents the comprehensive strength of a country's high-tech. In recent years, the medical device industry has developed rapidly, new technologies and new products emerge one after another, product diversity and complexity continue to increase, and the phenomenon of uncoded or multiple codes for medical devices in circulation and use is common, seriously affecting the production, circulation, and production of medical devices. It is difficult to achieve effective supervision and management of medical devices by accurately identifying them in all aspects including use.

The Australian TGA released guidance on July 12, 2023 for sponsors applying to make changes to entries in the Australian Register of Therapeutic Goods (ARTG) for medical devices or IVD products. It is intended to help sponsors maintain the information contained in the ARTG. is the latest and most correct.

In June 2023, the State Food and Drug Administration approved a total of 264 registered medical device products. Among them, there are 198 domestic Class III medical device products, 46 imported Class III medical device products, 19 imported Class II medical device products, and 1 Hong Kong, Macao and Taiwan medical device product (see the attachment for specific products).

On July 28, 2023 local time in the United States, the FDA officially announced the fee standards for the 2024 fiscal year, and the fee implementation time is from October 1, 2023 to September 30, 2024.

On August 1, local time, the British Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on the CE mark recognition of medical devices and in vitro diagnostic products.