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.
More MDD announced the closing of the ongoing trial scheme for expedited approval of Class II/III/IV General Medical Device Listing Application on 31 December 2021. The limit application for applicants who wish to apply through the trial scheme have been lifted.
More 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.
More A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.
More 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.
More 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.
More 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.
More 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.
More Following extensive consultation, China's Center for Medical Device Evaluation (CMDE) has issued guidelines for artificial intelligence medical software product classification and definition.
More PFDA held a virtual symposium where the industry stakeholders commented on two draft regulations: the addendum to FDAC 2021-002 and the list of class A medical devices. PFDA emphasized the transition period for the affected products in this symposium.
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