As ThaiFDA (Thailand Food and Drug Administration) comprehended the importance of such problems. Therefore, agreed in issuing the Ministry of Public Health Announcement regarding HIV Screening Kit by One Selves (Issue 2) 2019, amended on content that HIV Screening Kit is accessible for any individual with no prohibition of general public usage, being implemented from April 9th onward.
The Procedure for HIV Screening Kit application as follows:
1.Registrant prepared for product submission and product sample (imported or manufactured) for Standard Quality (MSC 4) at OSSC.
2. Registrant prepared product sample for Standard Quality Test at the Department of Medical Sciences.
3. The Department of Medical Sciences issues the test report.
4. Registrant prepared submission dossier for CSDT accordingly.
5. ThaiFDA approve for product efficiency and safety.
6. Registrant retrieve product approval certificate.
Please be aware that HIV Screening HIV is a preliminary initial screening only.
1. In case of self-examination results “Reactive” the recipient must be verified again from Hospitals. or clinics.
2. In case of self-examination results “Non-Reactive” it does not guarantee that the recipient is not infected with HIV, however the recipient must consider the risk of infection of their own such as having sex without using condoms, or touching the blood through wound/abrasions, etc. If there is a high risk of risk taking during 6-12 weeks before proceeded the use of HIV Screening Kit, it is decidedly suggested for recipient to retake HIV Screening Kit. Furthermore, HIV infected individuals who have received antiretroviral therapy may result in “False Negative” results.
At present (April 2019), there is no manufacturer or importer has received an Import License. Post- market HIV Screening Kit can be performed by professionals only.
Translated from official ThaiFDA announcement, by: