By virtue of the definition of "licensor" in Article 4 of Medical Device Act 2018. In addition, with the sixth, third and seventh paragraphs of the Ministry of Public Health Announcement regarding HIV Screening Kit by self-test 2019, on March 16, 2019, the Secretary-General of the Food or Drug Administration has issued the announcement as follows:
1. HIV Screening Kit by Self-test application can be prepared in full evaluation or concise evaluation. Qualification for HIV screening kit by self-test that is applicable for concise evaluation is as follows;a) Have received an approval or is registered and is marketed in 2 of 5 countries and is under complete authority of the countries as follows:
1) Australia (Therapeutic Goods Administrative: TGA)
2) Canada (Health Canada: HC)
3) European Union Notified Bodies: EU NB
4) Japan (Japan Ministry of Health, Labour and Welfare: MHLW)
5) United States (US Food and Drug Administrative: US FDA)
An approval or registered and marketing period of HIV screening kit by self-test must exceed a minimum of 1 year.
b) HIV screening kit by self-test that have received an approval or is registered and is marketed in 1 of 5 countries and is under complete authority of the countries as mentioned above. An approval or registered and marketing period of HIV screening kit by self-test must exceed a minimum of 1 year and is in WHO list of prequalified in vitro diagnostics products.
2. The preparation of full evaluation and concise evaluation shall comply with the safety and performance evaluation criteria of Food and Drug Administration Announcement regarding the criteria of full evaluation and concise evaluation on 4 October 2018;
3. Labelling, and device description must comply with Ministry of Public Health Announcement regarding HIV Screening Kit by Self-test 2019. Subject information must be display in flow chart. The flow chart must be instructive in case of self-examination results in “Reactive”; “Non-reactive” or “Invalid result” for subject.
4. Licensee registrant must prepare Usability Report;
5. HIV screening kit by self-test must employ sterilized, single use puncture device with a safe system such as safety lancets, needle automatically retracts, etc.
Translated from official ThaiFDA announcement, by:
References:
Ministry of Public Health Announcement regarding HIV Screening Kit by Self-test 2019