On June 16, 2022, it was published in the Official Gazette the Exempt Decree N°41 dated June 8, 2022, issued by the Undersecretary of Public Health, which incorporates the devices for HIV detection indicated, to the sanitary control regime established in article 111 of the Sanitary Code.

Whereas Article 1 of Law No. 19. 779 establishes as a duty of the State the elaboration of policies that tend to the prevention, diagnosis and control of the infection caused by HIV, and that, in accordance with article 111 of the Sanitary Code, within the measures established therein to ensure the quality of medical devices, it is that these shall be subject to the quality control regime established in article 111 of the Sanitary Code, is that they shall be subject to quality controls and standards subject to the technical specifications established by the official Chilean standards of the National Institute of Standardization and approved by the Ministry of Health by a founded decree, this decree is issued to incorporate, at the request of the ISP, the following medical devices to the aforementioned control system:

A. Instrumental assays for determination of anti-HIV antibodies.
Sensitivity 100% / Specificity ≥ 95%.
B. Visual / rapid assays for anti-HIV antibody determination.
Sensitivity 100% / Specificity ≥ 95%.
C. Visual / rapid assays for HIV self-testing.
Sensitivity 99% / Specificity ≥ 98%.

All of which will come into effect after 6 months of this publication, i.e. December 17, 2022.

Should you require additional information on this matter, please contact Andrea Abascal (aabascal@jdf.cl), and/or Rocío Vergara (rvergara@jdf.cl).