Thai FDA Announces New Application and Query Response Timelines
On April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.
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On April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.
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.
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.
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.
The TFDA will adjust the registration process and remove the initial pre-submission step beginning March 15, 2022. Beginning April 1, 2022, any classification and/or grouping questions can be submitted through a separate E-submission process for a 500 THB (US$15) fee each.
The TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.
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.
The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand.