On 20 August 2024, the Medical Device Control Division of TFDA released registration guidance for monkeypox (Mpox) diagnostic tests as a reference for the industry. Recently, the World Health Organization (WHO) declared the Mpox outbreak a public health emergency of international concern. As the outbreak is still in its early stages, information on diagnosis and treatment remains limited, and updates will be provided as more data becomes available.
The Division has prepared for the upcoming diagnostic test registration proposals from the industry by developing an efficacy and safety assessment form. Mpox diagnostic tests are classified as in-vitro diagnostic medical devices (IVDs) and require detailed notifications (Class B or C). The registration kits and reagents are categorized into two types:
Genetic Testing
Antigen Test Form
Experts will review and evaluate all technical documentation that was submitted for verification and validation before approval. Due to current development limitations and findings, these test kits and reagents are approved only for use by medical personnel and are not available for public use (self-testing). Please refer Medical Device Control Division for further steps to request detailed information on diagnostic tests for Mpox.
Contact us at info@arqon.com for more information.
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