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

Software as a Medical Device in Thailand

On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand.

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.

Thai FDA Reduces Application Review Time

On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.

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 QMS Updates to Affect GDP, GMP, and GCP

Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.

Thailand FDA to Decrease Registration Application Processing Times

The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.

Thailand FDA to Improve Medical Device Advertising Review Times

In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.

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.

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.

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.