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.
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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
India – Advertising Requirements
Sales Channel Establishment or Virtual Master Distributor services available, enabling foreign manufacturers to sell directly to regional distributors.
Philippines Advertising Requirements
Asia Actual helps manage the Medical Device Registration process in the Philippines through the complex regulatory and registration process.
Vietnam Medical Device Grouping
Asia Actual helps manage the Vietnam Medical Device Registration process through the complex regulatory and registration process.
Vietnam Medical Device Classification
Asia Actual helps manage the Vietnam Medical Device Registration process through the complex regulatory and registration process.
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.
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.