On June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 31st of every year covering installations of products under the licenses they hold. Originally, all license holders were supposed to upload the reports by the end of March but due to issues with the e-portal, the TFDA is requesting hard copies as soon as possible and online submissions completed by September 30, 2022. The reports must include the date of sale/installation, name of the product, license number, manufacturing information, customer information, quantity, and value of purchase.

According to the new regulations, products registered under new rules (apply to applications submitted after February 15, 2021) that were imported/sold in the previous year must be reported to the TFDA by March 31, 2022. License holders could be prosecuted and fined for not submitting reports in time. Manufacturers can determine if their product is registered under the old or new rules by the format of their registration number. If it’s 65-2-2-2-0002736, then the product was registered under the new rules whereas if the license number has a 3 letter country abbreviation followed by 8 numbers (i.e. FRA 7311311) was registered under the old rules.

The original post can be found here and a Google translated version can be found here.

Additional Notes

The TFDA has not ruled out that there will be exceptions to this rule and will entertain questions from manufacturers on whether their products need to be reported in this format. For example, there may be some medical devices like software that do not collect installation records of every customer and may not be able to be able to feasibly report this information.

Regarding the values the TFDA will expect to see, the Import Value is the Import Entry Declaration (THB) while the Value of Sale can include all amounts except for VAT.

For more information on registering your medical device in Thailand, please see our page on the topic here.