• 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

• 2021-10-27 06:53:26

HSA communicated to the public regarding a cybersecurity vulnerability named "BrakTooth". It affects various IOT devices, which includes medical devices that use specific Bluetooth Link Manager Protocols. HSA shared steps to shareholders to avoid or address issues pertaining to BrakTooth.

• 2021-08-26 11:53:27

More medical devices are being classified under India’s Medical Device Rule 2017 based on the intended use, risk associated with the device, and other parameters. They include device categories ranging from interventional radiology, rehabilitation, dermatological and plastic surgery, physical support, anesthesiology, and in-vitro diagnostic (IVD) medical devices.

• 2021-08-26 11:43:03

Indonesia’s Ministry of Health has introduced simplified routes for certain class A medical devices. The characteristics of certain class A medical devices themselves are Home Use, Non-Sterile, and non-IVD. The products which can be registered through a simplified route will need fewer documentation requirements compared to the regular registration route.

• 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 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.

• 2021-04-26 02:13:50

Health Sciences Authority (HSA) published “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-05-06 07:48:03

The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.

• 2020-02-14 04:14:45

Devices classification in Indonesia has followed ASEAN AMDD, which has been aligned to PERMENKES UU NO.62 years 2017. Medical Device classified into 4 risk classes (A,B,C,D based on level of risk)