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.
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.
Similar to other markets in the region, manufacturers of COVID test kits will need to undergo in-country validation as part of the Class 4 Licensing process 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.
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.
Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.
With the announcement of The Regulations and Conditions Of Maintaining Technical Documents For Safety And Effectiveness Of The Medical Device, the Thai FDA has begun requiring the local medical device License Holder to provide upon request technical documents for any registered device. As the registration process for most General Medical Devices (all but 10 device types fit into this category) does not involve technical documents, this new requirement will impact most medical devices.