• 2025-08-25 04:38:43

The Minister of Finance promulgated Circular 64 /2025/TT-BTC dated June 30, 2025, which lowered fees to alleviate difficulties and support production and business activities.

• 2024-09-17 02:03:36

The Minister of Finance promulgated Circular 43 /2024/TT-BTC dated June 28, 2024, which lowered fees to alleviate difficulties and support production and business activities.

• 2023-09-27 05:38:54

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.

• 2023-06-28 07:48:07

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 harmonized judgement of the significance of a change.

• 2023-05-24 07:30:46

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.

• 2022-06-29 02:14:40

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.

• 2022-02-18 08:16:14

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.

• 2021-09-30 07:43:02

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.

• 2021-08-01 14:48:08

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.

• 2021-06-25 13:10:29

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.