Home About Qualtech NEWS THAILAND: ThaiFDA Grants Access of HIV Screening Kit to the General Public - July, 2019
THAILAND: ThaiFDA Grants Access of HIV Screening Kit to the General Public - July, 2019

July 15, 2019

National Committee on Prevention and Solution for AIDS has realized and is concerned about the importance of individual infected situation. Encouragement of an action could happen by increasing access to self-diagnosis of HIV infection which will be an essential key that will lead to the end of AIDS problem.

ThaiFDA (Thailand Food and Drug Administration) comprehends 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. There are some mendedments on content that HIV Screening Kit is now 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 prepares for product submission and product sample (imported or manufactured) for Standard Quality (MSC 4) at OSSC.

2) Registrant prepares product sample for Standard Quality Test at the Department of Medical Sciences.

3) The Department of Medical Sciences issues the test report.

4) Registrant prepares submission dossier for CSDT accordingly.

5) ThaiFDA approves product efficiency and safety.

6) Registrant retrieves product approval certificate.

Please be aware that HIV Screening HIV is a preliminary initial screening only.

1) In cases of self-examination where the result is “Reactive”, the recipient must be verified again by a hospital or a clinic.

2) In cases of self-examination where the result is “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 blood through wound/abrasions, etc. If the recipient indulged in high-risky activities 6-12 weeks before proceeding to use the HIV Screening Kit, it is decidedly suggested for the recipient to retake HIV Screening Kit. Furthermore, HIV infected individuals who have received antiretroviral therapy may receive “False Negative” results.

At present (as of April 2019), there are no local manufacturers or importers who have received an Import License for the HIV Screening Kit. Post-market HIV Screening Kit can be performed by professionals only.

 

Reference:

Notification of ThaiFDA Legalized the Importation and Manufacturing HIV Screening Kit by One Selves

Ministry of Public Health Announcement regarding HIV Screening Kit by One Selves 2019

Ministry of Public Health Announcement regarding HIV Screening Kit by One Selves (Issue 2) 2019


Tags:
Thailand Medical Device Registration

 

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Home About Qualtech NEWS THAILAND: ThaiFDA Grants Access of HIV Screening Kit to the General Public - July, 2019