To make sure vigilance is compiled among related stakeholders, MHLW announced important reminders on hazard prevention measures based on research and surveys conducted.
More MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.
More The National Public Procurement Agency, which is responsible for managing the government e-Katalog, issued provision No 122/2022 concerning Procedures for Organizing Electronic Catalogues. This changed previous e-Katalog mechanisms includes the MoH Sectoral E-Katalog.
More MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.
More Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.
More China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 02, 03, 05, 06, 16, 18, as well as 20 of the Category of Medical Devices.
More China's National Medical Products Administration (NMPA) has issued guidance on nomenclature of generic name for 6 subcategories.
More The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.
More In the beginning of 2022, the Therapeutic Goods Advertising Code 2021 came into effect. Six month transition period were given, and sponsors and manufacturer were allowed to either follow the 2018 Code or the 2021 Code until 30th June 2022. From 1 July 2022 onwards the option of complying with the 2018 Code yet no longer applies.
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Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.
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