On February 4, 2025 (published February 21), Chile’s Ministry of Health approved Decree Exento No. 5, formally incorporating immunohematological reagents into the country’s sanitary regulatory framework. The regulation will take effect on February 22, 2026.
Key Requirements:
Mandatory Certification under NCh-ISO 16142/2:2021, with sensitivity and specificity testing overseen by the Public Health Institute (ISP).
Risk Classification as Class C and D, subject to a strict conformity assessment process.
Post-Market Surveillance, requiring that any changes to design, labeling, or intended use be reported to the ISP.
This move strengthens blood transfusion safety and aligns Chile with international standards recommended by PAHO.
For more details or support with compliance, please contact TrustCert.
