Covid Test Registration in Thai FDA is mandatory to import any kind of Covid Test Kit (PCR/Antigen Test Kit, OTC test/self-test/professional test) in Thailand.
The Procedure for Covid Test Registration in Thai FDA is divided in two macro-areas:
- Self Test – Over the Counter
- Covid test for professional use
The updated list of already approved test is available in Thai FDA website at THIS LINK
Thai FDA classifies ATK and PCR Covid Test as In Vitro Diagnostic Devices, and recognizes 3 kind of classes of Covid Test:
- Genetic Testing kits and reagents
- Antibody and antigen kits and reagents for automatic machines
- Kits and reagents for antibody and antigen rapid test
According to the above classification, the procedure changes.
Let’s say that a Covid Test Registration in Thai FDA is a process that may take 45 days in a straightforward case. Unlike most of Medical Devices, Covid tests MUST be tested in an FDA approved laboratory (at the moment there are 3 labs in the list), and tests must be provided also by manufacturer.
Procedure for ATK and PCR tests Thai FDA is in 8 steps, but we can summarize them i 3 actions:
- Samples import, that includes the agreement with the laboratory, the Temporary Import License, the custom clearance and the test in laboratory. In this phase we need to provide a detailed Executive Summary of the ATK or PCR test kit.
- Once obtained the test report, the ATK license application can be submitted to Thai FDA with the following documentation:
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- Product specifications (Technical Data Sheet and Brochure)
- Device Description (normally such information are included in the previous point)
- Test Report
- Manufacturing process
- Analytical performance Report
- Clinical Performance Report
- Stability Test Report
3. Upon verification of the dossier, FDA assign the process to a Scientifical Committee that will evaluate all the above documents and shall give final approval or reject the application.
Just like any other healthcare product, Covid Test Registration in Thai FDA is possible only to Thai entities in possess of a specific iImport License for this kind of products.
If you are planning to import ATK Covid test or PCR Test in Thailand, contact us for a quotation. If you don’t have a local company, we can act as License Holder on your behalf.
