• 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.

• 2022-04-27 11:25:06

The Malaysian Medical Device Authority (MDA) issued a new guideline document to assist in the registration application of COVID-19 IVD test kits via Medc@st for all previous applications that received Special Access Notification or Conditional Approval and new registration.

• 2022-02-18 08:32:17

PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.

• 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-02 04:21:25

In December 2020, MDA published the 2nd edition of the guidance document on the classification system of in-vitro diagnostic (IVD) medical devices. Compared to the 1st edition, this has a more solid and structured explanation for each classification.

• 2021-06-25 10:40:40

Medical devices cannot generally be imported, supplied in, or exported from Australia unless they are included in the ARTG (Australian Register of Therapeutic Goods. Only an Australian sponsor can apply to include an IVD (In Vitro Diagnostics) in the ARTG. TGA has now issued requirements to be fulfilled in order to include an IVD in the ARTG.

• 2021-05-22 05:11:57

According to the medical device registration conditions, any medical device that is intended for professional use may be supplied for use by medical professionals only and shall not be placed in the market for general public use.

• 2020-09-15 06:35:40

MDCG已針對在MDR / IVDR下進行的監督審核中使用MDASP審核報告的情況，為指定機構發布了指南。 對於具有相似或等效要求的人員，積極的QMS符合性結果可能會導致對關注方面的關注減少。

• 2020-02-21 07:07:01

IVD軟件變更，對於GN-21和GN-34，HSA添加了有關體外設備（IVD）中軟件更改通知的指南。