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. Like all other medical devices under the new Thai rules, the Thai FDA may take approvals in other countries into account but does not currently have an expedited review route for COVID test products approved in other markets including reference countries. Depending on the type of test, validation fees will vary from 65,000 baht (US$2,200) up to 143,200 baht (US$4,800) and could take 1-4 months to complete. Once validation testing has been completed, manufacturers can then submit their License application through their local office or license holder which incurs a US$1,775)

Validation Requirements

Requirements vary depending on the type of test with sample requirements varying from 100-200 samples. Antigen tests will even require a local clinical trial. Along with lab fees, there will also be a 3,200 baht TFDA application fee applicable to all products.

• Real Time RT-PCR tests will require 100 samples with lab fees not to exceed 100,000 baht (US$3,000). It is estimated that validation will require 30 working days plus the technology assessment (time required varies).
• Antibody tests will require 200 samples with lab fees not to 140,000 baht (US$4,600). Validation timeline is currently about 75 days but does depend on the number of products in the queue.
• Antigen tests will need to work with a local hospital to coordinate a clinical trial before being approved for sale in Thailand. The size, costs, and timelines will depend on the agreement made with the partner hospital plus 30 days for the TFDA’s review.

The TFDA has released a few guidance documents to help manufacturers better understand the process but are currently only available in Thai.

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Contact Asia Actual if you’d like to learn more about the regulatory process in Thailand or other markets in the region.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.