THAI FDA ALLOWS SALES OF AT-HOME HIV TEST KITS
On April 9, 2019, the Thai FDA released the Announcement of the Ministry of Public Health The test kit related to self-screening for HIV infection B.E. 2560, declaring that at-home HIV self-test kits can now be sold in Thailand upon regulatory approval with immediate effect.
HIV Self-Test kits still require a formal review by the Medical Device Control Division of the Thai Food and Drug Administration (FDA) according to the Medical Device Act, 2008, and Medical Device Ordinance, 2018 (as amended) as a Class 4, Licensed Medical Device a 9 to 14 month process.
Thailand Regulatory Process
Proof of regulatory approval in the country of origin had been a firm requirement for medical device registration in Thailand. However, from September of 2019 a new Concise Evaluation process was launched providing exceptions for the home-country-approval requirement (with exceptions).
Certain administrative documents such as the Free Sale Certificate and ISO certificate must be authenticated by the territorial Thai Consulate. Technical documents must be in Common Submission Dossier Template (CSDT) format as per the ASEAN Medical Devices Directive. Furthermore, Licensed medical devices are required to have performance tests generated from a local, licensed test laboratory.
Furthermore, given that the product will be used by a lay person, the Thai FDA also included specific labeling instructions such as official IFU translations and warning labels written in clear red lettering stating, “Do not use a self-screening test on people receiving antiretroviral therapy for HIV as this may result in a false negative” and “This is only to be used for manual screening and if HIV is detected, user must seek confirmation of the diagnosis from a healthcare professional.”
Thailand Registration Fees for a Class 4, Licensed device
The Thai FDA fees total ThB 98,100 (roughly US$3,110):
|1||Application Fee||ThB 100|
|2||Expert Review Fee||ThB 88,000|
|3||Approval Fee||ThB 10,000|
Import Licenses are valid through the validity period of the Certificate of Free Sales, up to a maximum of 5 years.
Information from. https://asiaactual.com