New Advertising Exemption in Thailand

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.

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.

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.

LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.

Thai FDA Streamlines Medical Device Registration Process

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.

Thai FDA Updates Medical Device Applications Fees

On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes.

Thai FDA Updates List of Chemical Pollutants

The TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.

Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status

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.

Thailand Implements New Medical Device Regulations

On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.