• 2022-02-18 09:29:35

Since January 18th, 2022, FDA formally classified the electrocardiograph software for over-the-counter use as class II (special controls).

• 2022-01-26 10:47:58

Recently, HSA has finalized the "Medical Devices Product Classification Guide" after concluding the discussion with stakeholders. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 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.

• 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

• 2021-08-26 11:37:06

Following extensive consultation, China's Center for Medical Device Evaluation (CMDE) has issued guidelines for artificial intelligence medical software product classification and definition.

• 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.

• 2021-04-26 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.

• 2021-02-19 08:45:21

NMPA has introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices, including management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

• 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

• 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.