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US

HEADQUARTERS

515 Congress Avenue, Suite 2100
Austin, TX 78701

+1 512 898-9222

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SOUTHEAST ASIA

HEADQUARTERS

116 Changi Road, #04-05
Singapore 419718

+65 3138-4148

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LATEST NEWS.

UDI Requirements in Singapore

Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.
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Taiwan FDA Increases Regulatory Fees for Medical Devices

The Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.
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COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia

At this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.
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