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US

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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 8800-3197

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LATEST NEWS.

China Fully Implements UDI Requirements for Class 3 Medical Devices

Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
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Korea MFDS Implements Medical Device Monthly Reporting Requirements

The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
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Philippines FDA Bans Mercury-Added Products

Released on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.
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