By Exempt Resolution No. 96 of December 16, 2022 and published in the Official Gazette on December 22, 2022, the Ministry of Health amended Decree No. 41 of June 16, 2022 of the Ministry of Health, which incorporates certain devices for the detection of HIV in the sanitary control regime of Article 111 of the Sanitary Code.
Decree No. 41 of June 2022 incorporated the following medical devices into the aforementioned control regime:
A. Instrumental assays for the determination of anti-HIV antibodies. Sensitivity 100% / Specificity > 95%.
B. Visual / rapid assays for the determination of HIV antibodies. Sensitivity 100% / Specificity > 95%.
C. Visual / rapid assays for HIV self-testing. Sensitivity > 99% / Specificity > 98%.
This incorporation implied that such medical devices must undergo a review by the Institute of Public Health, which will issue a document certifying that they comply with the regulations. The modifications introduced by this decree would come into force 6 months after its publication in the Official Gazette, which occurred on June 16, 2022.
Exempt Resolution No. 96 modified the aforementioned decree in two main aspects in order to give it a correct application:
1. In line with the Self-Testing Strategy promoted by the Ministry of Health, Article 4 of the Decree was modified, adding the obligation of labeling that visual/rapid tests must comply with, including a QR Code and a Unique Code and basic information for people who are tested through these mechanisms.
2. The beginning of the validity of the obligations contained in Decree No. 41 was postponed to December 31, 2023 for the devices indicated in letters A and B above.
The effectiveness of the amendments to Article 4, mentioned in point 1 above, will begin on June 30, 2023.