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- Philippines FDA Medical Device Labeling CMDN to CMDR Labeling Guidance May 7, 2024
- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
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China Fully Implements UDI Requirements for Class 3 Medical Devices
/in China, Latest Updates/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 Updates, 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 Updates, 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 Updates, 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 Updates, 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 Updates, 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 Issues Recommendation for Medical Device Clinical Data
/in China, Latest Updates/by Bryan GilburgFor medical device registration in China, one of the most important documents to be provided is clinical data.
China to Implement New Electrical Safety Standards for Medical Devices
/in China, Latest Updates/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.