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Dr. Thares Katsananawiwong, MD The Secretary General of the Food and Drug Administration said that the latest Ministry of Public Health, by the Food and Drug Administration (FDA) has issued the Ministry of Public Health's announcement on HIV-related diagnostic kits Issue 2) BE 2562 And the announcement of the Ministry of Public Health on self-examination kits related to the screening of HIV infection in 2019, published in the Government Gazette on April 9, 2019 The important aspect of amending the Ministry of Public Health is that there is a set of relevant key definitions. Determine quality, standards and requirements That must be produced by manufacturers who have been certified for production quality systems according to national standards or international standards such as Good Manufacturing Practices (GMP), ISO 13485, etc.
Including the prescription of labels to consumers on several important issues, such as indications, methods of use, storage methods, warnings, precautions, knowledge about the period of infection detection, not found in the examination kit (window period) Self Form -valuation for risk of HIV infection Channels to support information from manufacturers Or importers using such tests via QR Code or sites that provide information and knowledge Demonstrate how to check the summary of welding results in the service system. Telephone numbers that can be contacted for later consultation directly and interpretation, showing as a clear description of the picture AND has a message saying "Only manual screening is used. If reactive, it should be confirmed for diagnosis of HIV infection of a service that can confirm the diagnosis. "
In addition, the licensee for production Or import to provide documents on the information that the investigator must know (subject information) before the examination and after knowing the results of the exam By being in a container To make the consultation process be clear Beyond to connect to the system, diagnose, confirm, maintain and prevent services. What can be done in a clear step or process. Such information must be audited by the FDA in accordance with the announced rules
"Ending AIDS problems By unlocking public access to self-screening for HIV infection It is an alternative to screening rather than having to go to the hospital just to make people aware of the HIV status at the beginning Having the opportunity to prevent the transmission of HIV to others But in people with HIV risk behaviors The examination to know the infection status can soon start treatment immediately What will be beneficial to you and others "
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