Introduction

For more than two decades, Chile has regulated medical devices through the Decree 825 of 1998 issued by the Ministry of Health that approves the regulation and control for medical devices. Medical devices are regulated according to a complete four-class risk system, conformity verification rules and documentation requirements, but Article 22 made the market authorisation granted by the Health Authority and conformity verification rules conditional. The regime would apply progressively and only when the Ministry of Health issued a specific decree bringing a specific category into scope.

By the end of 2025, only ten categories had been brought in, including surgical and examination gloves, condoms, hypodermic needles and syringes, portable automated external defibrillators, HIV diagnostic tests and immunohaematology reagents. Everything else, including imaging equipment, ventilators, pacemakers, cardiac stents, dialysis machines and clinical software, could be imported and sold without a market authorisation. Thus, Chile does not have systematic regulation of medical devices.

In a market where most of the devices are imported, this regulation has made Chile an unusually easy jurisdiction to enter and an unusually difficult one to police and control. However, in the last year Chile has undergone significant regulatory changes that have the aim of strengthening the safety and quality of devices marketed in the jurisdiction. In fact, two decrees were published in a five-day period that brought roughly forty product categories into the mandatory regime now requiring a marketing authorisation granted by the authority.

This section of the guide aims to outline the latest trends, developments and the evolving regulatory environment that the medical devices industry is undergoing.

Regulation of Medical Devices

Article 111 of the Sanitary Code requires that instruments, apparatus and other items intended for the diagnosis, prevention and treatment of disease meet the quality standards applicable to them, with application to particular classes of device made effective through a founded decree issued by the Ministry of Health at the proposal of the Public Health Institute (Instituto de Salud Pública, or ISP). Decree 825 regulated said products, establishing four risk classes, escalating documentation requirements in accordance with their risk, a conformity verification certificate granted by an authorised establishment and a market authorisation granted by the ISP without which a product cannot be manufactured, imported, marketed or distributed.

Under this framework, medical devices are classified into four tiers based on their potential harm to the patient or user. These are:

• Class I (very low risk, such as bandages, cervical collars and standard manual surgical instruments);
• Class II (moderate risk, such as hypodermic needles, surgical gloves and removable dental prostheses);
• Class III (high potential risk, including dialysis equipment, anaesthesia machines and pulmonary ventilators); and
• Class IV (critical or very high risk, which covers pacemakers, heart valves, intrauterine devices and joint implants).

This risk-based categorisation inherently dictates the rigour of the scrutiny, clinical evidence, and documentation required for their conformity verification by the health authority.

The products that require market authorisation are only those established by the health authority by a decree regarding a specific category. For everything outside those categories, market entry required no registration. Manufacturers and importers remained responsible for general quality and safety rules, but there were no prior reviews and no product files lodged with the authority.

Import control filled part of the gap. Since 2018, devices without mandatory registration have entered under a Customs Destination Certificate (CDA), processed through the ISP’s GICONA platform, where the importer declares the products, risk class, legal manufacturer and storage warehouses before customs clearance. The CDA is a control and traceability tool rather than a substitute for registration.

Establishment regulation remained the weakest link. Decree 825 contains no systematic regime for companies that manufacture, import or distribute devices. In practice, the ISP requires sanitary authorisation for warehouses under good storage, distribution and transport practices.

Decree 25 of 2026: 39 New Categories

Exempt Decree No 25 of the Ministry of Health was signed on 6 March 2026 and published in the Official Gazette on 19 March 2026. It brings 39 categories of medical devices and in vitro diagnostic medical devices into the sanitary control regime under Article 111 of the Sanitary Code and Decree 825.

The prioritisation criteria are stated in the decree itself and are worth noting because they indicate how future decrees are likely to be built. The ISP looked at whether a product is critical under an existing ministerial classification, its risk class (Classes III and IV for devices, Classes C and D for in vitro diagnostics), whether it is used in services associated with ministerial plans or programmes, and whether adverse events involving it have been reported to the national vigilance system.

The categories brought in correspond to the following groups.

• High-risk implantables (Class IV) – Implantable defibrillators, pacemakers and cardioverters, including devices for resynchronisation therapy; cardiac stents and their implantation systems; cardiovascular catheters; heart valves; cochlear implants; hip endoprostheses; breast implants and expanders; implantable surgical meshes; implantable hyaluronic acid dermal fillers; and copper intrauterine devices.
• Infusion and blood handling – Insulin infusion pumps and accessories, and blood bags, both classified across Classes III and IV.
• Diagnostic imaging and radiotherapy (Class III) – Conventional X-ray equipment, mammography units, computed tomography scanners, nuclear medicine equipment including PET and SPECT, brachytherapy equipment, and external radiotherapy equipment including linear accelerators.
• Life support and critical care (Class III) – Mechanical ventilators, both fixed and transport; manual defibrillator monitors; extracorporeal circulation equipment; and electrosurgical units.
• Dialysis and ophthalmology (Class III) – Haemodialysis machines and accessories, haemodialysis catheters and filters, acid and base haemodialysis concentrates, and intraocular lenses.
• Software as a medical device (Class III) – Software for the processing and analysis of oncology images, and software for oncology image treatment planning.
• Class II devices – Continuous glucose monitoring systems, automatic sphygmomanometers, CPAP and BPAP devices, and steam or ethylene oxide sterilisation equipment.
• In vitro diagnostics – Tests for Helicobacter pylori, human papillomavirus, respiratory viruses (influenza A and B, RSV, parainfluenza, adenovirus, metapneumovirus and SARS-CoV-2), human chorionic gonadotropin (pregnancy tests and tumour markers), and glucose monitoring systems including meters, strips, lancets and control solutions.

The compliance deadlines for these products are staged according to said decree. Implantable and other high-risk devices have 24 months from publication (due in March 2028). Diagnostic equipment, clinical software and laboratory tests have 36 months (due in March 2029). From those dates, the listed products may only be manufactured in Chile, imported, marketed or distributed if they hold the corresponding conformity verification, which for these purposes means a market authorisation granted by the ISP.

What conformity verification will involve

The decree states that the ISP will carry out conformity verification by reviewing the documentation supporting the quality, safety and performance of the product, under Title IV of Decree 825 and against four general standards: NCh ISO 16142-1 and 16142-2 on recognised essential principles of safety and performance, NCh ISO 13485 on quality management systems, and NCh ISO 14971 on risk management.

On top of that general framework, the decree assigns product-specific standards to each of the 39 categories. Implantable cardiac devices are assessed against the ISO 14708 series, heart valves against ISO 5840-1, cardiovascular catheters against ISO 10555-1, intraocular lenses against ISO 11979, electro-medical equipment against the NCh-IEC 60601 series with the relevant particular standards, and the two software categories against IEC 62304.

In this regard, it is important to note one of the provisions, which deserves particular attention from foreign manufacturers. Where the specified national standard does not apply, the market authorisation holder may demonstrate compliance through alternative or complementary standards, national or international, provided these show compliance with internationally recognised essential principles of safety and performance.

Also, several procedural points are important for planning.

• Registration may be sought for a single product, a family, a group or a system, according to criteria the ISP will set.
• Post-registration changes to design, manufacture, intended use, raw materials, components, performance or labelling must be notified, and a significant modification triggers a new registration.
• The ISP is required to issue technical guidance defining what counts as significant.

The health authority also established a voluntary early route. Before the deadlines apply, importers, manufacturers and distributors may apply to the ISP for conformity verification voluntarily, once the corresponding technical instructions have been issued. Those instructions are due within 12 months of publication, meaning by March 2027. Companies with large portfolios should treat that as the real start of the process set forth by the decree.

In terms of enforcement, the control is shared between the ISP and the regional ministerial health authorities (SEREMIs) within their respective areas of competence.

Decree 31 of 2026: The Second Decree in One Month

Five days after Decree 25, on 24 March 2026, the Ministry of Health published Exempt Decree No 31, bringing in vitro diagnostic reagents used in the microbiological screening of blood donors into the sanitary control regime. These reagents detect transmissible infections in donated blood and are central to the daily operation of blood services.

The two March decrees, published five days apart, show that the mechanism for bringing categories into control, that were barely used for over two decades, is now being applied at speed. Manufacturers whose products fall outside the current lists should plan on the basis that further decrees will follow, particularly given the ISP’s stated objective of taking regulatory coverage of higher-risk devices from 0.7% to 100%.

Impact on CENABAST Tenders

Article 111 of the Sanitary Code conditions not only the importation but also the marketing and distribution of the listed products on holding the corresponding market authorisation. CENABAST’s standard tender terms, approved by Resolution No 87/2022 and still in force, already condition the admissibility and evaluation of bids on compliance with the sanitary regulation applicable to the offered product. As a result, the expansion of the universe of devices subject to mandatory registration under Decree 25 and Decree 31 translates, without any need for a specific amendment to Resolution No 87, into a new compliance requirement for suppliers bidding for devices captured by those categories, once the deadline applicable to each has expired. For companies that currently supply the State under multi-year framework agreements or contracts, this raises a supply-continuity risk if authorisation is not secured with sufficient lead time, which makes the voluntary early route described above particularly relevant for participants in the public procurement market.

Rebuilding the Regulator

Expanding the list of regulated products achieves little if the authority cannot process the resulting submissions. The ISP itself has put the scale of the gap plainly: of more than 12,800 higher-risk medical devices circulating in the Chilean market, only 94 were under regulatory control, roughly 0.7%. The stated objective is to take that figure to 100%.

To get there, the ISP secured funding of CLP2,500 million from the Chilean Economic Development Agency (CORFO) for the second stage of a project on strengthening the ISP for medical device regulation.

The programme runs for five years and is intended to strengthen the regulatory system for medical devices. On the normative side, it covers revising existing standards and regulations, issuing technical guidance, and drafting the procedures and instructions the framework currently lacks. On the staffing side, the ISP will both train its existing technical team and recruit new specialists, with the goal of assembling enough qualified people to handle registration, vigilance and enforcement at the volumes the new regime will generate.

The programme also commits the ISP to benchmarking itself against established foreign regulators and to introducing regulatory reliance mechanisms, bringing Chilean practice into line with international recommendations. Supporting this is a push on international co-operation, including working relationships with respected regulatory bodies and with the WHO, to keep knowledge and experience flowing in from outside.

Finally, the programme funds digital platforms and technology services intended to speed up regulatory processes, make them more transparent, and give both industry and the public better access to information. The stated ambition is a system that can absorb the sector’s growing demands and establish the ISP as a point of reference for device regulation in the region.

Legislative Initiatives

For years, commentary on medical device reform in Chile pointed to the Sanitary Code reform known as Fármacos II (Bulletin No 9914-11). That bill was filed on 10 March 2015 and remains in a Joint Committee following rejection of amendments. It has been in Congress for over 11 years.

The device industry criticised its treatment of the sector from the outset, on the basis that the bill was built for pharmaceuticals and applied the same logic to devices without accounting for the differences between them. Industry associations argued for recognition of approvals by high-surveillance regulatory agencies instead.

The bill that matters now is Bulletin No 17,375-11, which modernises the National Health Services System, strengthens the National Health Fund, creates a National Digital Health Service and grants powers to the ISP and to the central procurement agency. It was introduced pursuant to a commitment in Law No 21,674 of 2024 requiring the government to submit health reform legislation.

On devices, this bill would change the architecture rather than extend the list of those devices that require market authorisation. Its main features are as follows.

• An open-ended formula, so that authorisation is no longer confined to a fixed number of categories or generic groups. Mandatory registration or prior notification would apply according to risk level assigned to them by the regulation.
• Where a product has already been authorised by an international reference regulator designated by the ISP, the Institute would specify by resolution which documents may be omitted from the registration file. Separately, the ISP could recognise certifications issued abroad by certification bodies holding accreditation from an internationally recognised accreditation body.
• Powers for the ISP over domestic manufacture as well as imports, including the registration of importers, manufacturers, distributors and technical service providers, and control over establishments carrying out reprocessing and reuse.
• Concentration of control and enforcement in the ISP nationally, with the ability to delegate enforcement to the regional health authorities, since the ISP has no regional offices.
• Staged implementation – 18 months to issue the implementing regulation, after which differentiated deadlines apply according to risk class. Industry should therefore plan on a horizon measured from the regulation rather than from the law itself.

The bill was introduced on 31 January 2025 and its progress is well advanced by Chilean standards. The Senate Health Committee voted on 70 amendments and referred it to the Finance Committee on 10 December 2025, and it remains in its first constitutional stage. The provisions described above are those of the bill as introduced; companies should verify the current consolidated text as well as the current stage before relying on any particular requirement or timetable.

Given that Chile imports the majority of its devices, the sudden expansion of the registration universe makes reliance on foreign assessments the single most commercially significant open question.

The institutional precedent already exists within the same agency. The ISP established an internal procedure for applying a reliance mechanism to the registration of biological pharmaceutical products by Exempt Resolution 679/2025, and has since granted approvals for diabetes, cancer and shingles medicines through that route. Extending the same logic to devices is a smaller institutional step than building it from nothing.

Decree 25 already contains a partial version of it, in the clause permitting alternative national or international standards that demonstrate compliance with internationally recognised essential principles. Bulletin No 17,375-11 would go considerably further by putting recognition of foreign regulatory approvals on a statutory footing.

One further driver is worth noting. The ISP currently holds Level IV Regulatory Agency status from the Pan American Health Organization, but that assessment does not extend to medical devices. The certification the government is pursuing from the WHO, measured through the Global Benchmarking Tool, would cover them. The device chapter of Bulletin No 17,375-11 is expressly modelled on the WHO Global Model Regulatory Framework for Medical Devices of 2023.

Connected Devices, Software and Clinical Data

Two further developments intersect with device regulation. Law No 21,719 on personal data protection comes fully into force on 1 December 2026. It classifies health data as sensitive, requires impact assessments before processing clinical information, and creates a data protection agency with powers to investigate on its own initiative, issue binding instructions and impose fines of up to 4% of annual turnover. For manufacturers of wearables, remote monitoring platforms and diagnostic software, this sits alongside and partly overlaps with post-market vigilance obligations.

The second is the bill regulating artificial intelligence systems, which adopts a tiered risk approach. Decree 25 has already brought oncology imaging software into sanitary control, and AI-assisted diagnostic tools sit at the intersection. The open question is how two independently designed risk classification regimes, one horizontal and one sectoral, will apply to the same product without duplicating assessments or leaving gaps. Companies developing clinical software with AI components should follow both instruments closely.

Adjacent areas likely to gain relevance

These further areas are worth monitoring, although none is yet at the centre of the debate.

• Telehealth and digital health – the Telehealth Framework Law increasingly intersects with the registration regime for medical software, to the extent that telemedicine platforms incorporate diagnostic or clinical decision support functions qualifying them as software as a medical device.
• Electro-medical waste – extended producer responsibility legislation already treats electrical and electronic equipment as a priority product, but no specific decree covers complex electro-medical waste such as diagnostic equipment, monitors and ventilators.

Practical Steps for Companies

The deadlines in Decree 25 look distant, but the work needed to meet them is not. Companies with products on the list should be doing the following now.

• Map the portfolio against the 39 categories and confirm which deadline applies to each product, since the 24-month and 36-month tranches split across a manufacturer’s range.
• Audit existing technical documentation against the standards assigned to each category, and identify where CE or FDA files can be reused under the alternative standards clause.
• Confirm ISO certification is current and covers the relevant product scope, since it is a general requirement across the whole list.
• Decide whether to use the voluntary early registration route once the technical instructions are issued, rather than filing alongside every competitor in the final months before the deadline.
• Appoint and document a Chilean authorised representative, and confirm that storage and distribution arrangements meet warehouse authorisation requirements.
• Establish post-market vigilance and traceability processes, including the internal procedure for identifying and notifying significant modifications after registration.

Although a big step, the decree-by-decree expansion appears to be only the first step in a broader and stricter new regulation intended to strengthen the safety, quality and control of medical devices. If Bulletin No 17,375-11 passes in substantially its current form, the list-based approach will give way to a general, permanent, risk-based registration regime covering the whole device universe, with a reliance mechanism attached. Companies that build a compliance function around the 39 categories alone risk having to rebuild it within a few years.