Bryan Gilburg - China

“The TFDA is planning to cut the pre-screening time from 30 days to 1 and cut application review times by up to 40%.”

Noi Suwannabot

General Manager, Asia Actual Thailand

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Thai FDA to Decrease Registration Application Processing Times

Published on: January 25th, 2024

On January 15th and 16th 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. Likewise, the target review time for risk class 2-4 medical device application review times are being reduced from 200 days to 120 calendar days without an Expert Review; and from 250 days to 150 calendar days for applications subject to Expert Review. These changes are expected to be fully implemented in Q1 of this year.

Advertising Review Time Update

Another welcome change is that advertising approval application for certain risk class 1 medical device will be subject to automatic approval. More information on this announcement can be found here.

The advertising review process in Thailand poses challenges and consumes time, particularly for advertisers targeting direct-to-consumer markets. The TFDA scrutinizes all advertisements to verify the accuracy and substantiation of the claims made. Advertisements targeting Healthcare Professionals (HCPs) are exempt from mandatory review but must be submitted through an online portal before being placed on the market.

Come Grow with Us

Please contact Asia Actual with any questions or requests for support in Thailand. We have offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia. Our mission is to provide a stable, reliable local platform so that our clients can grow their sales in challenging Asian markets.

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Blog Posts

Map showing Vietnam where updates to CSDT are taking place.
Map showing Vietnam where updates to CSDT are taking place.
Map showing Vietnam where updates to CSDT are taking place.

Vietnam’s MoH Updates Class C and D Application Requirements

Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.