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- Key Takeaways from Vietnam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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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.
Taiwan FDA Launches New ePortal for Medical Device Applications
/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
Vietnam’s MOH Holds Conference on Price Declaration
/in Latest Updates, Vietnam/by David VoThe conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.