LABELING REQUIREMENTS

There are no specific labeling regulations for general medical devices from Thai FDA. By default, labeling is regulated by the Office of the Consumer Protection Board which requires labeling to include the manufacturer’s name or trademark, country of origin, intended use, importer information, storage condition, lot or serial number, and more. In general, the information on the label must be true and accurate and not cause confusion, must be in Thai or Thai with a foreign language(s) that can be seen and read clearly, and must be easily visible on the product, container, package or included in the product manual documentation.

MEDICAL DEVICE ADVERTISING APPROBAL IN THAILAND

The Medical Device regulations in Thailand include the requirement that all advertising material (e.g., print, internet, or video) used in Thailand for a registered medical device must be reviewed and licensed by the Thai FDA as per Notification B.E. 2553 (2010). Applications are processed in 30 days for a fee of ThB 1,000. Once issued, Advertising Licenses are valid for up to 3 years, or the term of the Import License, whichever comes first.

MEDICAL DEVICE SOFTWARE IMPORTING IN THAILAND

Even when a SaMD has no physical form and is delivered over the internet (without a Customs clearance process), the device will still be required to have a fully licensed medical device importer. The Importer will be responsible for post market vigilance reporting, the proactive traceability of devices on the market and retention of device history documents. At this time, there are no specific requirements regarding version controls, but manufacturers should expect to notify the Thai FDA if adding additional intended uses or making significant changes to the software’s functionality.

MEDICAL DEVICE SOFTWARE INVOICING IN THAILAND

As with all registered medical devices sold in Thailand, invoicing must be done by a local importer/distributor with a valid Establishment License issued by the Thai FDA. The local agent will be responsible for collection, payment and reporting of Value Added Tax payments to the Revenue Department. Foreign manufacturers that offer software as a service and employ a sales model to bill hospitals directly, will have to adjust this practice for Thailand. The applicable VAT tax is currently 7%.

Asia Actual has an experienced team of regulatory and commercial experts in Bangkok to provide medical device registration, license holding and importing support services to medical device manufacturers. Contact us with any questions or request for support with your AI software in Thailand.