On August 20, 2024, Thailand FDA published an infographic about the registration of diagnostic tests for Monkeypox (Mpox) in Thailand. The information shared is as follows:
● Monkeypox Diagnostic Test is categorized as Medical devices for in vitro diagnostics (IVD) group and classified as Notify medical devices (Class B or C portal).
● Documents for the Verification and Validation part are mandatory to be reviewed or evaluated by experts.
This announcement serves as a reminder for importers or local manufacturers to register their test kits to Thai FDA prior to marketing the product in Thailand.
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