Chile - Incorporation of the Products Indicated into 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

Business description

The regulatory proposal aims to incorporate 39 medical devices (DMDs) and in vitro diagnostic medical devices (DMDIVs) into the sanitary control regime established under Article 111 of the Sanitary Code and Supreme Decree No. 825 of 1998 by the Ministry of Health in Chile. This will be achieved through a conformity verification system based on ISO/IEC international standards.

- Ensure the quality, safety, and performance of critical medical devices used in the Chilean health system.

- Prioritize the control of higher-risk devices (Classes III and IV for DMDs; Classes C and D for DMDIVs).

- Align national regulations with WHO recommendations and international standards.

- Protect patient safety by implementing risk-proportional controls.

Source: G/TBT/N/CHL/762

Countries:

Chile

Product categories:

Medical Devices

Technical aspects:

Safety

Business fields:

P.05 Medical

Regions:

South-America

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