News Details
Chile Updates Technical Standards for Hypodermic Needles and Syringes
Chile’s Ministry of Health has announced updated regulations to strengthen quality and safety controls on hypodermic needles and syringes, bringing the country’s standards in line with international medical devices standards. According to the decree published on the 9 October 2025 in the Diario Oficial, all sterile, single-use needles and syringes sold or used in Chile must comply with the updated national technical standards, NCh2503:2021 for needles and NCh2504/1:2021 for syringes. The decree formally repeals the previous 2007 regulation (Decree 1.887 Exento) governing hypodermic devices, which is considered outdated and no longer reflect current scientific and technological developments.
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 they can be manufactured, imported, or marketed in Chile. Any modification to a product’s design, materials, or intended use must also be reported to the ISP, which will determine whether new verification process is needed.
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)
We acknowledge that the above information has been compiled from MINISTERIO DE SALUD.
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