Recent regulatory updates in Chile, made it mandatory to obtain pre-marketing approval in order to sale several types of IVD-MDs for HIV testing in the country that were not previously regulated.
Since 19-Dec-1995 only some specific IVDs, to be used in blood banks for testing of HIV, HTLV I-II, hepatitis B, hepatitis C, Syphilis and Chagas, had to be approved by the Chilean regulatory authority (ISP). With issuance of Decree 41 of 16-JUN-2022, this requirement is being extended to instrumental tests for HIV (even if not to be used in blood banks) and to rapid ("visual") HIV tests for professional or self-test diagnostic. These in-vitro diagnostic medical devices will be now subject to mandatory control and pre-marketing approval. This requirement entered into effect on 08-DEC-2022 for self-test IVDs and will enter into effect on 22-DEC-2023 for other type of HIV tests.
Please refer to the following regulation (in Spanish) for additional details:
Decreto 41 EXENTO (from 16-jun-22). [Regulation that] Incorporates the HIV detection devices indicated to the Sanitary Control Regime established in Article 111 of the Sanitary Code and in Supreme Decree No. 825 of 1998 of the Ministry of Health. [As updated by Decreto 96 EXENTO (from 22-Dic-2022)]
