The Minister of Finance promulgates Circular 44/2023/TT-BTC dated June 29, 2023, and Circular 59/2023/TT-BTC dated August 30, 2023, to adjust administrative fees in the health sector.
More This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonised judgement of the significance of a change.
More To mitigate the risk of nanomaterials, the amendment has been made by the Therapeutic Goods Administration (TGA) to the existing Essential Principle 7 to include the additional obligations. The amended Essential Principles checklist can be viewed and downloaded from TGA’s website.
More MDCG 2022-6 provides clarifications on the concept of ‘significant changes in the design and intended purposes’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26th May 2022 during the transition period.
More Hong Kong's MDD has announced a few changes in the trial schemes on the acceptance of some reference agencies approval. MDD also announced the regularization of the expedited approval scheme for Class II/III/IV General Medical Devices.
More
On July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021.
More TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.
More China's Regulations on the Supervision and Administration of Medical Devices have undergone a series of changes recently. In this article, let's take a look at these changes and how you can prepare to implement them in your medical devices in the China market.
More
The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.
More The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.
We collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.
