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Thai Requirements for COVID Test Kits
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.
Thai FDA Ramps Up Documentation Requirements for General Medical Devices
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.
THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET
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.
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.