The Malaysian Medical Device Authority (MDA) now allows for multiple authorized representatives for medical devices. This was announced on 14 September 2021, by repealing Circular Letter No. 1/2014 for Establishments Carrying Out the Role as an Authorized Representative (AR) and Establishments Carrying Out Various Activities, which was effective as of
The Health Sciences Authority (HSA) Singapore has adopted the Medical Device UDI system. This came into effect on 27 August 2021 with the issuing of new UDI Submission Guidelines. The purpose of this system is to improve registered medical devices’ traceability by: Enabling timely identification of devices affected by recalls,
The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. This requirement was published in Decision No. 2426/QDBYT on 15 May 2021 and came into effect
The Singapore Health Sciences Authority (HSA) has issued draft regulatory guidelines on the Classification of Software as a Medical Device that are open for consultation by stakeholders. Comments may be submitted until 19 August 2021. The draft guidelines cover the classification of non-IVD standalone mobile medical device applications commonly known
The Philippines Food and Drug Administration (FDA) has issued a second amendment to its guidelines on FDA-issued authorizations due to the ongoing global pandemic and community quarantine requirements. FDA Circular 2020-024 entitled “Updated guidelines for applications of authorizations with the FDA in light of community quarantine declarations” was first issued
During the COVID-10 pandemic a list of essential medical devices was drawn up as they were deemed essential for public health in combatting Coronavirus. These products also had a mandatory price ceiling fixed. The Philippines government has since decided to extend this measure to medical devices in general in order
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