Industry regulation

Regulation of medical devices in Chile

Legal definition of Medical Device

Medical devices (“dispositivos médicos” in Spanish) are instruments, apparatus, appliances, materials or articles, including software, used by themselves or in tandem, and defined by the manufacturer to be used directly on human beings, when the main expected action on the human body is not achieved by pharmacological, immunological or metabolic means, although those means can contribute to its function; with the purpose of diagnosis, prevention, follow up, treatment or relief of sickness, damage or disability; of research or replacement or modification of the anatomy or of a physiological process or the regulation of conception (Decree N˚ 825/98, article 2, n˚1). The same idea is expressed in article 111 of the Sanitary Code, which covers instruments, apparatus, devices and other articles intended for the diagnosis, prevention and treatment of human disease, or the replacement or modification of human anatomy, that are not pharmaceutical substances. As explained below, the regime now expressly reaches in vitro diagnostic devices (IVD) and software as a medical device (SaMD).

Import Process

According to the Sanitary Code and Decree 825/98, the regulation of medical devices is done progressively, via specific Decrees signed by the Ministry of Health. These specific Decrees specify the devices’ Class and so the regulatory controls and requisites that apply to them.

Devices are divided into four different classes, which have different regulatory requirements. The class is determined by the Decree that submits the devices to regulation. The classes are the following:

Class I:

Devices that have very low risk.

Class II:

Devices that have moderate risk.

Class III:

Devices that have an elevated risk potential.

Class IV:

Devices considered critical risk.

For in vitro diagnostic devices, the newest regulation follows the international classification of Classes A to D, prioritising the higher-risk Classes C and D (and some Class B tests).

For many years only a few kinds of devices were under mandatory regulation:

• Examination gloves, surgical gloves and condoms (Decree 342/2004).
• Hypodermic sterile single-use needles and syringes (Decree 1887/2007).
• Condoms (Decree 93/2018).
• Automated external defibrillator (Decree 42/2021).

This changed substantially in March 2026, when a large group of devices was incorporated into the regime (see “Devices now under mandatory regulation” below).

According to article 3 of Decree 825/98 and article 111 of the Sanitary Code, persons or companies that want, at any title, to fabricate, import, commercialize or distribute medical devices subject to the regime need to obtain a certification of the verification of conformity from services, institutions, laboratories or establishments holding a specific sanitary authorization issued by the “Instituto de Salud Pública” (Public Health Institute, or ISP) of Chile. The ISP is the authority that authorises and supervises those conformity bodies and, where none exist, performs the verification itself. According to the ISP, there are currently no private bodies accredited for the newly regulated devices, so the ISP carries out the verification directly.

The import process must also follow the usual regulations for bringing items into the country. The importer must obtain a customs destination certificate (CDA) and the ISP’s authorization of the use and disposition of the goods, processed at http://giconaweb.ispch.gob.cl/. The COVID-19 suspensions and the special allowance to import face masks for personal or employee use, mentioned in earlier versions of this note, are no longer in force and should be disregarded.

Devices now under mandatory regulation (Decree 25/2026)

Decree 25 of 2026 (published on 19 March 2026) incorporated thirty-nine categories of medical devices, in vitro diagnostic devices and software as a medical device into the sanitary control regime of article 111 of the Sanitary Code and of Decree 825/98. This is the most important change to the device regime in years.

For these devices, the verification of conformity takes the form of a sanitary registration (“registro sanitario”) granted by the ISP. The verification is documentary: the ISP reviews the records and documents that support the quality, safety and performance of the device. Conformity is assessed against the Chilean standards NCh ISO 16142-1 and 16142-2 (essential principles of safety and performance), NCh ISO 13485 (quality management systems) and NCh ISO 14971 (risk management), as well as device-specific standards listed in the Decree; the holder may also prove compliance through equivalent national or international standards. National manufacturers and importers must present evidence of compliance with the applicable Chilean standards or their updated international equivalents.

Once a device is registered, any change to its design, manufacture, intended use, raw materials or components, performance, labelling or other relevant characteristics must be notified to the ISP, and a significant modification requires a new registration. The registration can be requested for a single product, a family, a group or a system.

The Decree applies with a deferred and staggered entry into force, counted from its publication on 19 March 2026:

• 24 months (from 19 March 2028) for the highest-risk devices, mainly Class IV implantables and related products:
  • Implantable defibrillators, pacemakers and cardiac cardioverters (including those for resynchronisation).
  • Stents (cardiac endoprostheses) and implantation systems.
  • Cardiovascular catheters and cardiac valves.
  • Cochlear implants; hip endoprostheses and accessories.
  • Breast implants and expanders; implantable surgical meshes; implantable hyaluronic acid dermal fillers.
  • Copper-containing contraceptive intrauterine device (IUD).
  • Insulin infusion pumps and accessories; blood bags.
• 36 months (from 19 March 2029) for the remaining devices, including most capital equipment, in vitro diagnostics, software and Class II devices:
  • Manual defibrillator monitors; conventional X-ray equipment; brachytherapy and external radiotherapy equipment (including linear accelerators).
  • Mammography equipment; computed tomography; nuclear medicine equipment (including PET and SPECT).
  • Haemodialysis concentrates, equipment, accessories, catheters and filters.
  • Intraocular lenses; mechanical ventilators (fixed and transport); extracorporeal circulation equipment; electrosurgical units.
  • Software for processing/analysis and for treatment planning of oncological images (SaMD).
  • Continuous glucose monitoring systems; automatic sphygmomanometers; CPAP/BPAP; steam or ethylene oxide sterilisation equipment.
  • In vitro diagnostic tests for Helicobacter pylori, Human Papillomavirus (HPV), respiratory viruses (Influenza A/B, RSV, parainfluenza, adenovirus, metapneumovirus, SARS-CoV-2), human chorionic gonadotropin (pregnancy / tumour marker) and glucose monitoring kits.

Before the regime becomes mandatory, importers, manufacturers and distributors may apply voluntarily for the sanitary registration, once the ISP issues the corresponding technical instructions. Those instructions must be issued within twelve months of publication, that is, by 19 March 2027.

Regulatory Conditions to sell medical devices

Specific regulatory conditions for selling devices do not exist in the general regulations but can be imposed by the specific Decree that regulates the medical device. As with imports, to sell a medical device subject to mandatory regulation a verification of conformity must be obtained – certification by an accredited institution under the older decrees, or the ISP sanitary registration under Decree 25/2026.

There are no general requirements regarding manufacturers (other than, following the definition, that they define the device as to be used directly on human beings) or the initial importer (other than obtaining the needed authorization, where the device is under mandatory regulation). Devices commercialised or distributed without the required certificate may be seized by the sanitary authority (article 111(f) of the Sanitary Code), and the cost of the certifications is borne by the person who requests them.

Advertisement of medical devices

There are no specific restrictions for advertisements regarding medical devices, though they could be imposed by Decrees regulating specific medical devices, and the general consumer-protection rules on misleading advertising apply. There are, however, restrictions on advertisements for pharmaceutical products, defined by the Sanitary Code and specific Decrees.

Technovigilance

Producers and importers take part in the process to avoid malfunctions and to ensure they are handled as soon as they happen. This is governed by General Technical Norm N° 204 (Decree 144 of 2018, published 16 January 2019). Each company has to appoint a person who monitors the performance of the medical devices and maintains contact with the health authorities and the customers.

An investigation must be made any time a malfunction is reported. This investigation, as well as the measures to be taken and the final outcome, must be reported to the health authorities (ISP). If needed, the medical devices must be withdrawn from the market. A trend report and an annual report must also be made by the producers and importers, who must keep a system to stay up to date on the international alerts regarding the products they sell.

Traceability

Two technical norms have added traceability obligations that affect anyone supplying devices to hospitals and clinics. Technical Norm N° 226 (Decree 63 of 2022) requires institutional health providers to register data allowing the traceability of medical devices at the moment of reception, so they can be quickly identified, immobilised, quarantined or withdrawn when a sanitary alert occurs. As a practical consequence, suppliers must deliver devices with documentation (a delivery note or invoice) that records the product’s condition as a medical device and the required traceability data. All stages of this norm are already in force.

Technical Norm N° 247 (Decree 33 of 2025) goes further, moving from traceability at reception to integral registration and control of prioritised devices throughout their life cycle, from reception to use or implantation in the patient, with a minimum standardised data set aligned with international post-market practice. It enters into force on 1 April 2027, after which institutional customers will require more detailed data from their suppliers. In addition, Technical Norm N° 158 (Decree 1.125 of 2013) sets the health-information standards for medicines and devices that underlie these data formats.

Liability for defective devices

Title VI of Book Four of the Sanitary Code (introduced by Law 20.850) establishes a special liability regime for defective sanitary products, which include medical devices. A device is defective if it does not offer the safety that may legitimately be expected, or the same safety normally offered by other units of the same series. The holders of the registrations or authorizations, the manufacturers and the importers are jointly and severally liable to the injured party for the damage caused by a defective device; the one who pays may then seek recourse against the others according to their participation in the damage.

The defendant cannot escape liability by arguing that the defect could not be foreseen given the state of scientific or technical knowledge when the product was put into circulation. The injured party must prove the defect, the damage and the causal link; the action prescribes after five years from the manifestation of the damage. Importantly, manufacturers and importers must keep an insurance policy, an aval or an equivalent financial guarantee to respond for health damage derived from safety problems of their products.

Exporting medical devices to Chile

These are the topics a company wanting to export medical devices must have in mind if they want to export their products to Chile.

Chilean regulatory requirements relevant to the arrangement

The first step is to determine whether the products fall under the older mandatory decrees (gloves, condoms, needles and syringes, defibrillators), under the thirty-nine categories of Decree 25/2026, or under none of them, because this decides whether a sanitary registration is, or will become, a condition to import and distribute. If the products are listed in Decree 25/2026, a registration before the ISP becomes mandatory from 19 March 2028 for the high-risk implantables and from 19 March 2029 for the rest, with voluntary early registration possible once the ISP issues its technical instructions (due by 19 March 2027). A contract signed today should therefore plan for the registration during its initial term.

Beyond registration, the distributor as importer must obtain the customs destination certificate (CDA) and the ISP’s authorization of use and disposition for each shipment; comply with technovigilance (appoint a contact person, investigate and report adverse events, prepare trend and annual reports, monitor international alerts and run market withdrawals); include the traceability data required by Technical Norm N° 226 in its sales documentation; notify changes to the device to the ISP; and keep the insurance or equivalent guarantee required for manufacturers and importers. Depending on the logistics, the distributor’s warehouse may also need a sanitary authorization from the regional health authority (SEREMI).

Contractual provisions that may require modification

International distribution templates usually need the following adjustments to work under Chilean law:

• Make the sale of regulated devices conditional on obtaining and keeping the ISP sanitary registration, and align the term, minimum purchases and forecasts with the 2027, 2028 and 2029 dates, with relief if the ISP process is delayed.
• State clearly who applies for and holds the sanitary registration and the technical file. If the distributor holds it, add the duty to transfer or cancel it on termination, with cooperation duties and access to the dossier; if a manufacturer affiliate holds it, give the distributor the right to operate under it.
• Review the liability and indemnity clauses against Title VI of the Sanitary Code: liability to injured third parties is joint and several and cannot be excluded between the parties as against those third parties, and the “state of the art” defence is not available; the parties should instead pre-allocate the recourse between them (for example, the manufacturer bears design and manufacturing defects, the distributor bears storage, handling and promotion). Liability caps and consequential-damage exclusions should carve out product liability and recalls.
• Add the mandatory insurance, aval or equivalent guarantee for the manufacturer and the importer; a generic “reasonable insurance” clause is not enough.
• Include detailed recall and field-safety provisions, since a withdrawal can be mandatory: decision rights, compliance with ISP orders, logistics, customer notices, cost allocation and reporting to the ISP.
• Insert mutual adverse-event notification with short deadlines so the importer can meet its ISP reporting duties, plus the manufacturer’s duty to share international alerts and safety information.
• Require advance notice of any change to design, components, intended use, performance or labelling, so the distributor can notify the ISP or seek a new registration before shipping the modified product, and allocate the re-registration cost.
• Oblige the manufacturer to supply the lot/serial data and compliant labelling needed for the traceability norms, and oblige the distributor to include that data in its delivery documentation and to keep distribution records to lot level.
• Allocate responsibility for Spanish-language labelling and instructions for use, add audit rights and record-keeping consistent with the five-year liability period, and provide for cooperation in ISP and SEREMI inspections.
• Remember that a foreign governing-law clause does not displace the Chilean public-law duties (registration, vigilance, recalls, liability to Chilean injured parties); the survival clause should keep the vigilance, recall, recourse-allocation and record-keeping duties alive after termination, and address the sell-off of registered stock.

Obligations that should be expressly allocated between the parties

Because the law exposes both parties to the authority and to third parties, each of the following should be assigned expressly in the agreement:

• Sanitary registration: who is the applicant and holder, who prepares the dossier, who provides the technical documentation and ISO certificates (the manufacturer) and who files and liaises with the ISP (usually the distributor), who bears the costs, and what happens to the registration on termination.
• Import authorizations: the CDA and the ISP use-and-disposition authorization for each shipment, normally the importer’s task with the manufacturer’s supporting documents.
• Technovigilance: the local contact person, the handling and investigation of complaints, the reporting to the ISP, the trend and annual reports, and the monitoring of international alerts (with the manufacturer feeding its global data to the distributor).
• Recalls and withdrawals: who decides, who executes, customer notification, reverse logistics, replacement or refund, cost allocation according to the cause, and reporting completion to the ISP.
• Change notifications and re-registration: the manufacturer notifies changes, the holder files with the ISP, and the parties allocate costs and any ban on selling the modified product until it is approved.
• Traceability and records: the manufacturer supplies lot/serial data and labelling, and the distributor includes the Technical Norm N° 226 data in its documentation and supports the customers’ life-cycle traceability from April 2027.
• Storage and distribution: the distributor is responsible for authorised and compliant warehousing, cold chain where needed and stock rotation, following the manufacturer’s storage and transport conditions.
• Insurance and financial guarantees: each of the manufacturer and the importer keeps its statutory cover, and the agreement allocates the recourse exposure between them.
• Inspections and sanctions: cooperation in ISP and SEREMI inspections and sanitary proceedings, allocation of fines according to fault, and indemnities for the seizure of non-conforming product.

Finally, because the ISP still has to issue the technical instructions and resolutions that implement Decree 25/2026 (due by 19 March 2027), the agreement should include a clause obliging the parties to revisit the operational annexes – vigilance, traceability and quality – once those in

Last modified: 12/06/2026