September 2021

Malaysia Authorized Representative

Malaysia MDA allows multiple authorized representatives for medical devices

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 17 June 2021 in accordance …

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Andaman Medical virtual exhibitor at Advamed Medtech Conference 2021

Andaman Medical is a virtual exhibitor at Advamed’s Medtech Conference 2021

Andaman Medical is proud to be a virtual exhibitor at this Advamed Medtech Conference 2021.  Victoria Caldy and Jon Avent will be on hand to answer attendees’ queries on registering their medical devices and medical equipment in the Southeast Asian countries of Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam.  As a provider of on-site medical …

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Singapore adopts Medical Device Unique Device Identifier

Singapore HSA adopts Unique Device Identifier system

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, failures, serious adverse events, Field …

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