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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022
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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.
China to Require All Electromedical Devices Meet Updated Standards
/in China, Latest Updates/by Bryan GilburgThis adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.
TFDA Implements New Annual Reporting Requirements in Thailand
/in Latest Updates, Thailand/by Bryan GilburgOn June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 30th of every year.
Philippines FDA Issues New Guidance for Vet Products
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.
TFDA Updates Review Timelines for Medical Device Applications
/in Latest Updates, Thailand/by Bryan GilburgA Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.