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- China Fully Implements UDI Requirements for Class 3 Medical Devices June 29, 2022
- Korea MFDS Implements Medical Device Monthly Reporting Requirements June 28, 2022
- Philippines FDA Bans Mercury-Added Products June 27, 2022
- Taiwan FDA Medical Device Advertising Requirements June 26, 2022
- TFDA Expands Reliance Route to Include All B/C/D Singapore Registrations June 9, 2022
- Thai FDA Announces New Application and Query Response Timelines June 8, 2022
- China to Implement New Electrical Safety Standards for Medical Devices May 15, 2022
- Taiwan FDA Launches New ePortal for Medical Device Applications May 10, 2022
- Vietnam’s MOH Holds Conference on Price Declaration April 11, 2022
- China to Require All Electromedical Devices Meet Updated Standards April 10, 2022
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China Fully Implements UDI Requirements for Class 3 Medical Devices
/in China, Latest News/by Bryan GilburgBeginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
Korea MFDS Implements Medical Device Monthly Reporting Requirements
/in Latest News, South Korea/by Sarah BaikThe Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
Philippines FDA Bans Mercury-Added Products
/in Latest News, Philippines/by Charmaine RosonReleased 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.
Taiwan FDA Medical Device Advertising Requirements
/in Latest News, Taiwan/by Eric LeungThe Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
TFDA Expands Reliance Route to Include All B/C/D Singapore Registrations
/in Latest News, Thailand/by Bryan GilburgOn June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.
Thai FDA Announces New Application and Query Response Timelines
/in Latest News, Thailand/by Bryan GilburgOn April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.
China to Implement New Electrical Safety Standards for Medical Devices
/in China, Latest News/by Bryan GilburgAn updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.
Taiwan FDA Launches New ePortal for Medical Device Applications
/in Latest News, Taiwan/by Eric LeungThe Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications