Chile Strengthens Medical Device Regulations

The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted through Decree 5 Exempt, was promulgated on February 4, 2025, and published in the Official Gazette on February 21, 2025. The regulation will come into effect one year later, on February 22, 2026.

According to the Ministry of Health, this regulatory update aims to enhance patient safety by enforcing strict compliance with quality standards for these devices. The decree mandates that all immunohematological reagents must undergo a verification of conformity and certification process, in accordance with the following standards:

• NCh-ISO 16142/2:2021 – Essential Principles of Safety and Performance for In Vitro Medical Devices.

• Evaluation of first-lot performance – Sensitivity and specificity assessments conducted by the Chilean Institute of Public Health (ISP).

Key Provisions of Decree 5 Exempt

The new regulation establishes that:

1. Mandatory Certification: Immunohematological reagents must comply with regulatory quality and safety standards before they can be manufactured, imported, marketed, or distributed within Chile.

2. Risk Classification: These reagents are classified under risk classes C and D (III and IV), in accordance with Chilean medical device regulations.

3. Regulatory Oversight: The Institute of Public Health (ISP) will oversee the verification of conformity and certification process, ensuring adherence to the designated quality standards.

4. Post-Market Surveillance: Any modifications to the design, manufacturing process, intended use, raw materials, labeling, or performance of these devices must be reported to the ISP for further evaluation and approval.

Impact on the Healthcare Sector

This regulatory update is expected to improve patient safety, ensure blood transfusion reliability, and align Chilean medical device regulations with international standards. The Pan American Health Organization (PAHO) has strongly recommended that national regulatory authorities take responsibility for verifying the quality, safety, and efficacy of blood-related medical devices and reagents. Chile's adoption of these measures follows international trends in strengthening healthcare safety frameworks.

The public consultation process, conducted between February and April 2023, gathered input from industry representatives and healthcare professionals. This feedback contributed to refining the regulation, ensuring a smoother transition and effective implementation. The Ministry of Health encourages all stakeholders, including healthcare providers and medical device manufacturers, to review the decree and take necessary steps for compliance before the regulation comes into force in 2026. 

The implementation of Decree 5 Exempt represents a significant step toward enhancing Chile’s regulatory oversight of medical devices. For further details you can find the Decree (in Spanish) here.