On August 21, 2023, TGA released the latest guidance on the reclassification of medical devices, as follows:Reclassification of active medical devices intended for therapeutic use with diagnostic functionsThe guidance aims to help sponsors of therapeutically active medical devices with diagnostic functions meet their obligations and outlines transition arrangements to help comply with the new regulation.

1. In addition to the registration requirements stipulated in the Health Products Act, local supply and use must comply with other legislation, such as the Private Hospitals and Clinics Act, the Medical Services Act, the Professional Registration Act (medical registration, dental registration, etc. ) and the Radiation Protection Act.2. The Medical Device Single Audit Program (MDSAP) certificate is in addition to the current list of acceptable QMS certificates.

The Guorui Zhong'an Group IVDAER team will regularly summarize the update of laws and regulations in Relevant market and regulatory websites (such as the EU, Australia, China, etc.), so that you can know and update the laws and regulations involved in a timely manner.

On July 12, 2023, the Australian TGA issued guidelines for applicants applying for changes to entries in the Australian Register of Therapeutic Goods (ARTG) for medical devices or IVD products, aimed at helping applicants maintain the latest and most accurate information contained in the ARTG.

Center for Medical Device Technology Evaluation of the State Drug Administration: For products included in the catalog of in vitro diagnostic reagents exempt from clinical trials, no less than 100 samples should be selected for research during clinical evaluation. Quantitative detection reagents with different reference intervals due to known physiological changes (such as different female menstrual cycles, sex, age, etc.), such as luteinizing hormone detection reagents, have different references in women of different sexes and different menstrual cycles For the interval, the expected applicable population samples and interference samples should be selected for the concentration coverage linear/measurement interval for research, and it is not necessary to perform stratified statistics on the population of different reference intervals. For detection reagents with significantly different guiding significance for clinical decision-making with reference intervals for different populations, such as full-scale C-reactive protein detection reagents, at least 100 samples should be included in the applicable population of hypersensitivity and general-purpose reference intervals for clinical evaluation, and different stratified statistics of the population.