• 2021-08-02 04:25:55

Back in December 2020, MDA had published a new guidance document on grouping in-vitro diagnostic medical devices. This guidance is an extension of the MDA/GD/0005 Guidance Document of Product Grouping focused on IVD devices.

• 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.

• 2021-08-01 16:05:20

The Indonesian Ministry of Health has issued new guidance on Withdrawal and Destruction of Non- Conformity Medical Devices. It describes the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation. It is hoped to assist manufacturers, importers, and distributors in better managing post-market activities such as the withdrawal of medical devices in Indonesia.

• 2021-08-01 15:22:19

The PRC State Council has issued the new regulation of Supervision and Administration of Medical Devices—or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021, creating new market access opportunities for global medical device and IVD manufacturers.

• 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.

• 2021-06-25 12:28:19

As previously notified, the CDSCO has expanded the list of regulated medical devices in India, ranging from CT scan equipment, MRI equipment, defibrillators and more, in addition to all types of implantable devices

• 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 05:31:34

The Indonesian Ministry of Health has issued guidance on reporting of Adverse Events (in Indonesia: Kejadian Tidak Diinginkan/ KTD). The guidance book explains the types of adverse events (KTD) that must be reported to the Ministry of Health and the reporting period.

• 2021-05-22 03:59:29

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.