Chile medical device registration expanded on March 19, 2026, when Exempt Decree No. 25 was published in the Official Gazette. The decree adds 39 medical devices and in vitro diagnostic devices to the sanitary-control regime established under Article 111 of Chile’s Sanitary Code.
The new requirements will take effect in stages, 24 or 36 months after publication depending on the product. Before the applicable effective date, manufacturers, importers, and distributors may voluntarily seek conformity verification and registration after the ISP issues its technical instructions.
What Changed
The decree follows a gradual, risk-based approach. Chile prioritized higher-risk products, including Class III and IV medical devices and Class C and D in vitro diagnostic devices, as well as products used in national health programs or associated with reported adverse events.
The products identified by the decree will be subject to sanitary registration and conformity-verification requirements according to the implementation schedule established by the regulation.
Chile Medical Device Registration Requirements
For products covered by the decree, manufacturers, importers, and authorized representatives may need to address requirements that include:
- Sanitary registration through the ISP
- Documentation supporting product quality, safety, and performance
- Conformity with applicable national or recognized international standards
- Quality-management and risk-management documentation
- Notification and assessment of significant product changes
The decree references standards including ISO 16142-1, ISO 16142-2, ISO 13485, and ISO 14971 as part of the framework used to demonstrate conformity with recognized principles of safety and performance.
Phased Implementation
The new requirements will take effect according to the phased schedule established in the decree. Before the applicable mandatory dates, manufacturers, importers, and distributors may seek voluntary conformity verification after the ISP issues the corresponding technical instructions.
The decree provides that the relevant technical instructions and implementing resolutions are to be issued within 12 months of publication.
Chile Medical Device Registration: What Manufacturers Should Consider
Companies marketing or planning to introduce medical devices or IVDs in Chile should determine whether their products fall within the scope of the decree and identify the implementation dates that apply.
Manufacturers should also review product classification, available conformity evidence, quality and risk-management documentation, local representation, and potential registration responsibilities before the applicable requirements become mandatory.
RJR can help companies assess how Chile medical device registration requirements may affect their products, documentation, implementation timelines, and market-entry strategies. Start a conversation with RJR.
Sources: Instituto de Salud Pública de Chile — New Regulation Covering 39 Medical Devices and IVDs | Chile Exempt Decree No. 25 of 2026