Chile Expands Mandatory Health Registration to 39 Categories of Medical Devices: Key Aspects of Exempt Decree No. 25 of 2026
Chile Takes a Major Step Forward in Medical Device Regulatory Oversight
Medical device regulation in Chile is entering a new phase. Exempt Decree No. 25 of 2026, issued by the Ministry of Health and published in the Official Gazette on March 19, 2026, incorporates 39 categories of medical devices and in vitro diagnostic medical devices (IVDs) into the health control framework established under Article 111 of the Health Code and Supreme Decree No. 825 of 1998.
This represents a significant regulatory change: once the implementation periods have elapsed, the products covered by the Decree may only be manufactured in Chile, imported, marketed, or distributed if they have undergone the corresponding conformity assessment. For the purposes of the Decree, this conformity assessment takes the form of a health registration granted by the Chilean Institute of Public Health (ISP).
Therefore, domestic and foreign manufacturers, importers, distributors, and product holders should begin reviewing their portfolios, the adequacy of their technical evidence, and the regulatory strategy applicable to each device. Waiting until the end of the transition period may result in regulatory observations, market access delays, or avoidable business disruptions.
What Does Exempt Decree No. 25 of 2026 Establish?
The regulation follows a gradual, risk-based approach. It prioritizes Class III and IV medical devices, Class C and D IVDs, products associated with public health programs, and technologies for which adverse events have been reported through the Technovigilance System.
In practical terms, the Decree introduces five key regulatory components:
- Mandatory health registration for the 39 categories included, according to the implementation schedule.
- Documentary review by the ISP to demonstrate product quality, safety, and performance.
- Application of essential principles and general and specific technical standards.
- Obligation to notify relevant post-registration changes.
- Regulatory oversight by the ISP and the Regional Ministerial Health Secretariats, within their respective areas of competence.
Which Medical Devices Will Require Health Registration in Chile?
The list includes diagnostic technologies, implants, medical equipment, Software as a Medical Device (SaMD), and therapeutic support products. For easier reading, it can be grouped as follows:
| Group | Products Covered |
| IVDs and monitoring | Tests for Helicobacter pylori, HPV, respiratory viruses, and human chorionic gonadotropin; glucose monitoring and continuous glucose monitoring systems. |
| Cardiology and implants | Implantable defibrillators and cardioverters, stents, cardiovascular catheters, heart valves, cochlear implants, hip implants, breast implants, surgical meshes, dermal fillers, and copper IUDs. |
| Dialysis and life support | Hemodialysis concentrates, equipment, catheters, and filters; mechanical ventilators; extracorporeal circulation equipment; insulin infusion pumps; and blood bags. |
| Diagnosis and treatment | Defibrillator monitors, X-ray equipment, brachytherapy and external radiotherapy equipment, mammography systems, CT scanners, PET and SPECT equipment, intraocular lenses, and electrosurgical units. |
| Software and other equipment | Software for oncological image processing, analysis, and planning; automatic sphygmomanometers; CPAP/BPAP devices; and steam or ethylene oxide sterilization equipment. |
Implementation Timeline: 24 and 36 Months
The implementation periods are calculated from the publication of the Decree on March 19, 2026. Therefore, unless subsequently amended, the key regulatory dates are:
| Period | Reference Date | Products / Requirements |
| 12 months | March 19, 2027 | Deadline for the issuance of the technical guidelines and complementary resolutions provided for under the Decree. |
| 24 months | March 19, 2028 | Implantable and other higher-risk products included in the first implementation group: categories 6 to 18. |
| 36 months | March 19, 2029 | Equipment, IVDs, SaMD, and other products included in the second implementation group: categories 1 to 5 and 19 to 39. |
Before mandatory requirements enter into force, manufacturers, importers, or distributors may voluntarily request conformity assessment once the ISP issues the corresponding technical guidelines. This creates a strategic opportunity to prepare submissions in advance and reduce operational pressure as the deadlines approach.
Technical Requirements for Conformity Assessment
The ISP will conduct conformity assessments through the review of information and documentation supporting the product’s quality, safety, and performance.
The Decree adopts the following standards as its general framework:
- NCh ISO 16142/1: Essential principles of safety and performance for medical devices other than IVDs.
- NCh ISO 16142/2: Essential principles of safety and performance for IVDs.
- NCh ISO 13485: Quality management systems for regulatory purposes.
- NCh ISO 14971: Risk management applied to medical devices.
In addition, the Decree assigns specific standards to each category, including ISO and IEC standards addressing electrical safety, electromagnetic compatibility, performance, software, sterilization, implants, and diagnostic systems. Domestic manufacturers or importers must provide evidence of compliance with the applicable Chilean standards or, where appropriate, with updated equivalent international standards or the international standards specified in the Decree.
The regulation also allows compliance to be supported through alternative or complementary national or international standards, provided they demonstrate internationally recognized essential principles of safety and performance. This flexibility does not eliminate the need for sound technical justification: the equivalence, relevance, and validity of the supporting evidence must be clearly documented.
Health Registration May Cover a Single Product, Family, Group, or System
The Decree establishes that an application may cover a single product, family, group, or system, according to the criteria to be established by the ISP. This definition will be particularly relevant for companies with broad portfolios, multiple models, accessories, or configurations.
An appropriate grouping strategy may optimize regulatory management. Conversely, insufficiently supported grouping may lead to regulatory observations or fragmentation of the project. Before defining the structure of each application, companies should assess factors such as design comparability, intended use, operating principles, materials, manufacturing processes, and performance evidence.
Post-Registration Changes: When Could a New Registration Be Required?
Regulatory oversight does not end once authorization is granted. If a registered device undergoes changes to its design, manufacturing process, intended use, raw materials or components, performance, labeling, or other relevant characteristics, the change must be notified to the ISP whenever it could affect the device’s safety or performance.
If the change is considered significant, a new health registration will be required. The ISP must issue technical guidelines defining which modifications will be considered significant. Companies should therefore strengthen their change-control procedures and ensure effective coordination between headquarters, manufacturers, registration holders, importers, and the local registration holder or local representative in Chile.
What Is the Impact for Medical Device Manufacturers and Companies in LATAM?
Although Exempt Decree No. 25 of 2026 is a Chilean regulation and does not itself establish a regional registration or automatic mutual recognition mechanism, its impact extends beyond the local market. It directly affects manufacturers and corporate groups across Latin America that market products in Chile, manage regional regulatory dossiers, or coordinate product launches from regulatory hubs located outside the country.
The Chilean model reinforces trends increasingly visible in medical device regulation across LATAM: risk-based classification, quality management system requirements, documented risk management, use of ISO/IEC standards, and increased lifecycle oversight. In this context, evidence prepared for Chile should form part of a broader regional strategy, without assuming that the same dossier can be submitted unchanged across different markets.
For multinational companies, the key challenge will be to develop a reusable regional technical dossier while maintaining local requirement matrices for Chile and other jurisdictions. This can help reduce duplication while preserving regulatory traceability.
How Should Companies Prepare for the New ISP Health Registration Requirements?
A reasonable transition plan should begin before the technical guidelines are published. SCR Consulting recommends considering the following actions:
- Identify whether each product, model, accessory, software, or IVD in the portfolio falls within one of the 39 regulated categories.
- Confirm the risk classification, intended use, and commercial configuration authorized for Chile.
- Conduct a gap analysis against NCh ISO 16142/1 or 16142/2, NCh ISO 13485, NCh ISO 14971, and the applicable specific standards.
- Review the validity, traceability, and consistency of certificates, test reports, risk management documentation, clinical or performance evidence, and software documentation.
- Determine whether the registration strategy should cover a single product, family, group, or system, and technically document the proposed grouping.
- Align change-control and post-registration communication procedures among the manufacturer, importer, and local responsible party.
- Monitor the issuance of ISP guidelines and resolutions to adjust the dossier and evaluate the possibility of an early voluntary submission.
SCR Consulting: Regulatory Support for Medical Devices in Chile, Peru, and Bolivia
The new regulatory landscape requires more than compiling certificates. Companies will need to interpret the scope of the Decree, define an appropriate grouping strategy, identify technical gaps, and coordinate evidence generated across different markets.
SCR Consulting provides specialized support in medical device regulatory affairs in Chile, Peru, and Bolivia, including applicability assessments, classification, gap analyses, dossier preparation and review, registration strategy, regulatory follow-up, and post-registration change management.
If your company manufactures, imports, or distributes any of the products covered by Exempt Decree No. 25 of 2026, now is the time to assess your portfolio and develop a regulatory roadmap before the transition deadlines increase demand before the health authority.
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Author
- César Aylas Flórez, General Manager & Executive Director for Peru, Bolivia and Chile at SCR Consulting. Senior Consultant in Regulatory Affairs, Regulatory Intelligence and Regulatory Strategy.