Minister of Finance of Vietnam Promulgates Circular Prescribing Fees in Medical Device Sector
Circular 59/2023/TT-BTC introduces regulations on fees in medical sector, and the collection, transfer, management and use thereof. Such fees in …
Singapore HSA Revises Medical Device Adverse Events Reporting Guideline
Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update: – Included …
Singapore HSA Updates Medical Device Adverse Event Reporting Form
Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As …
Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification
Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS …
Singapore HSA Updates Guidance on the Risk Classification of IVD Medical Devices (GN-14)
Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical …
Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device
MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the …
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can …
Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023. This guidance …
Singapore HSA Enhances Medical Device Change Notification Process
Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect …
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