Chile Updates Technical Standards for Hypodermic Needles and Syringes

Chile’s Ministry of Health has announced sweeping new regulations to tighten quality and safety controls on hypodermic needles and syringes, bringing the country’s standards in line with international norms for medical devices. Under a decree published on the 9th of October 2025 in the Diario Oficial, the government will require all sterile, single-use needles and syringes sold or used in Chile to meet updated national technical standards, NCh2503:2021 for needles and NCh2504/1:2021 for syringes. It formally repeals the previous 2007 regulation (Decree 1.887 Exento) governing hypodermic devices, which officials say are outdated and no longer reflect scientific and technological advances.

New Certification Rules

The decree mandates that all products in these categories be certified by authorised bodies recognised by the Instituto de Salud Pública (ISP) before being manufactured, imported, or marketed in Chile. Any modification to a product’s design, materials, or intended use will also have to be reported to the ISP, which may require a new verification process.

12-Month Transition Period

The new standards will come into force 12 months after publication, in October 2026. Until then, existing products certified under the previous 2007 decree may continue to be sold, though any new certifications must comply with the revised standards. Officials confirmed that oversight and enforcement will be carried out by the ISP and regional health authorities, with inspections focused on ensuring compliance with the updated norms.

For further details, you can consult the Regulation here (in Spanish)