China to Implement New Electrical Safety Standards for Medical Devices
An 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.
New Search
If you are not happy with the results below please do another search
259 search results for:
Taiwan FDA Launches New ePortal for Medical Device Applications
The 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
The 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
This 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
On 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
The 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
A 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.
Singapore’s HSA Removes Classification and Grouping Inquiry Option
Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.
Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)
Singapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022.
Philippines Extends Grace Period for Registration of Certain Medical Devices
The Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.