A list of recently updated articles regarding medical device regulatory updates from the TFDA and other governing bodies in Thailand.

Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.

Thailand FDA Publishes Guidance for Software as Medical Device

On December 12th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand.

Thai FDA Implements Initial Screening Step to Submission Process

Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.

Medical Device Advertising Requirements in Asia

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

How New EU MDR Requirements Will Affect Registrations in Asia

As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

What is CSDT Documentation?

Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”

Thai FDA Fast Track Route for COVID Related Products to Stop

The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.

TFDA Expands Reliance Route to Include All B/C/D Singapore Registrations

On June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.

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.

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.