• 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 12:02:05

In light of the latest COVID-19 situation in Malaysia, MDA has published a guidance document on medical face masks and respirators. The MDA/GD/0033 explains the minimum requirements for labeling as well as the performance characteristics of face masks and respirators that need to fulfill.

• 2021-08-26 11:57:56

The MDA has published new guidelines for temporary conditional approval for the COVID-19 self-test kit (COVID-19 RTK), which explains the application procedure and requirements that need to be followed by the establishment.

• 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.

• 2021-08-26 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.

• 2021-08-01 15:52:06

The Australian medical device market is mature, with a well-formed regulatory system. With 80% of its medical devices being imported and huge emphasis placed on smart medical devices, let's take a look at this robust market and its regulatory system, in this article.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.