When a medical device is not subject to mandatory health registration in Chile, the ISP Background Review may serve as a technical and commercial support tool. Learn when it applies, what its scope is, and how to integrate it into a market-entry strategy.
Exempt Decree No. 25 of 2026 brings 39 categories of medical devices and IVDs under Chile’s mandatory health registration framework. We analyze the products covered, implementation timelines, and regulatory implications for companies operating in LATAM.
1. Perú: These are the documents required to import the following products: Medicines – Health Registration or Certificate of Registration and Summary Sheet (VUCE) – Certificate of Analysis (batch) – GMP Certificate or equivalent – Official Import Certificate (COI) and RD Authorization for Entry (For psychotropics and narcotics) Biologicals and human plasma derivatives – Health […]
In Peru and Chile, medical devices are classified based on the potential or residual risks associated with their use. This classification considers criteria such as the duration of body contact, the degree of invasiveness, and both local and systemic effects. Practically, devices are grouped by the level of risk they present, categorized into: Class I: […]
Q.F. Walther Ricardo Vicente MallmaQA Specialist & Regulatory Affairs Coordinator – Medical DevicesSCR Consulting Peru In Peru, medical devices are regulated by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). DIGEMID, as a line organ of the Ministry of Health, supervises all aspects related to the approval, denial, modification of the sanitary registration of […]