For medical device registration in China, one of the most important documents to be provided is clinical data.
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.
The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
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.
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.
On June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 30th of every year.
The Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.
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.
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