In Chile, the regulatory framework governing medicinal products (including biologicals), medical Devices (MD), food, and food supplements is primarily grounded in the Health Code (Código Sanitario DFL N°725, 1967 ), which establishes the general statutory basis for sanitary control, administrative oversight, inspection powers, and enforcement. Regulatory implementation is entrusted principally to the Ministry of Health (Ministerio de Salud), the Institute of Public Health of Chile (Instituto de Salud Pública or ISP ), and, in the field of food regulation, the Regional Health Authorities (Secretarías Regionales Ministeriales de Salud o SEREMIS).

Human Medicinal products, including biological products, are mainly regulated under Supreme Decree N°3, 2010 , which approved the National System for the Control of Pharmaceutical Products for Human Use. This regime governs, inter alia, marketing authorization, importation, manufacture, storage, distribution, advertising, and pharmacovigilance. The ISP acts as competent authority for registration, regulatory, control and post-authorization oversight. Biological products are, as matter of principle, regulated within the pharmaceutical framework, subject to any applicable technical rules or guidance issued by the health authority.

Medical devices are regulated under the Health Code and Supreme Decree N°825, 1998 , which sets out the control regime applicable to medical products and devices intended for diagnostic, preventive, therapeutic, or anatomical replacement/modification purposes. The Chilean system is administered by the health authority through a public-law control model focused on sanitary supervision, market oversight, and product control.

Food is principally governed by the Food Sanitary Regulation (Reglamento Sanitario de Alimentos), enacted by Supreme Decree N°977/1996 , which regulates composition, safety, hygiene, labelling, manufacture, storage, importation, and marketing food products. As regards Food Supplements, Chilean law generally treats them as a subcategory of food rather than as medicinal products. Accordingly, they fall primarily within the scope of the Food Sanitary Regulation and may not lawfully be presented with therapeutic, preventive, or curative claims. Where a product’s composition, presentation, or claims are such that it more properly qualifies as a medicinal product, the competent authority may subject it to the pharmaceutical regulatory regime instead. This reflects a functional distinction in Chilean law between foods and products making medicinal claims.

In Chile, the regulatory process applicable to medicinal products and medical devices is structured based on the Health Code (Código Sanitario) and its supplementary regulations, and generally comprises a clinical research phase, a pre-market control stage, and a post-marketing surveillance system, all under the principal supervision of the Institute of Public Health of Chile (ISP).

In the case of medicinal products, including biologicals, the core regime is set out in Supreme Decree N°3/2010, pursuant to which clinical trials in human subjects require prior authorization from the ISP and the favorable opinion of the competent scientific ethics committee. Commercialization is, as a general rule, subject to the prior grant of a sanitary registration, after which the products remains subject to pharmacovigilance and regulatory inspection.

Unlike pharmaceutical products, medical devices are not subject to sanitary registration. Instead, commercialization requires a conformity certification (certificación de verificación de conformidad), issued by ISP-authorized entities or, in their absence, by the ISP directly. Devices are classified into four risk classes: Class I (very low risk), Class II (moderate), Class III (high) and Class IV (highest). Conformity requirements scale with the assigned class.

Importantly, the mandatory control regime does not apply to all medical devices on the market. Incorporation of a device category is effected by a reasoned Ministry of Health decree at the ISP’s proposal. As of today, only eleven product categories are subject to mandatory conformity certification. The most recent addition is immunohematological reagents, incorporated in Classes III and IV by Decree Exento N°5/2025, which also subjects them to a mandatory first-lot analytical evaluation by the ISP. Devices commercialized without the required certificate are subject to seizure (Article 111(f), Health Code).”

In Chile, food supplements are primarily regulated under the Food Sanitary Regulation (Reglamento Sanitario de los Alimentos), enacted by Supreme Decree No. 977/1996, in particular Articles 534 et seq., which define food supplements as products specially prepared to supplement the diet for health-related purposes. As a general rule, food supplements do not require prior sanitary registration equivalent to that applicable to medicinal products, provided they fall within the food-law framework and comply with the applicable requirements on composition, permitted ingredients, labelling and advertising. Their labelling must comply with the Food Sanitary Regulation and, where applicable, with Law No. 20.606 on nutritional composition and food advertising. Post-marketing control is exercised mainly by the Regional Health Authorities (SEREMI de Salud) through inspections, sampling and enforcement measures. There is no formal pharmacovigilance system equivalent to that applicable to medicinal products; however, unsafe or misclassified products may be subject to sanitary measures, and products making therapeutic claims or otherwise falling outside the food-law framework may be reclassified by the competent authority and subjected to a different regulatory regime.

Regarding Medicinal Products:

• Renewal of Sanitary registration before the ISP every five years, pursuant to the Health Code and Supreme Decree N°3/2010, which governs the validity, renewal, suspension and cancellation of pharmaceutical registrations.
• Ongoing pharmacovigilance obligations, including the duty to report suspected adverse drug reactions, keep the product’s safety profile up to date, and comply with the technical instructions issued by the ISP, under Supreme Decree N°3/2010 and General Technical Standard (Norma General Técnica) N°140 on Pharmacovigilance.
• Continuous compliance with the authorised conditions of the product and with the regulatory requirements applicable to manufacture, importation, storage, labelling, distribution and advertising, in accordance with Supreme Decree N°3/2010.
• Prior processing before the ISP of relevant post-authorisation changes, such as changes to the formula, manufacturer, labelling or other approved particulars, pursuant to Supreme Decree N°3/2010.
• Management of quality defects and market withdrawals, with the corresponding communication to the health authority where applicable, under the Health Code and Supreme Decree N°3/2010.

Regarding Medical Devices:

• Continued compliance with the applicable sanitary control regime for the specific category of device, under the Health Code, Supreme Decree N°825/1998, and the special rules that have brought certain device categories within mandatory sanitary control.
• Post-market surveillance through the national technovigilance system, including the reporting of incidents or adverse events and cooperation with any safety measures required, in accordance with General Technical Standard N°204, approved by Decree Exento N°144/2018.
• Compliance with traceability obligations, particularly in institutional healthcare settings, under General Technical Standard N°247, approved by Decree Exento N°33/2025.
• Notification and regulatory handling of relevant modifications that may affect the device’s safety, performance or authorised conditions, depending on the sanitary regime applicable to that device category.
• Implementation of corrective measures, safety alerts or withdrawals, where required, within the general framework of sanitary control and medical-device vigilance.

In Chile, the principal authorities with regulatory oversight over medicinal products, medical devices, food and food supplements are the Ministry of Health (MINSAL), the Institute of Public Health of Chile (Instituto de Salud Pública, or ISP), and the Regional Health Authorities (Secretarías Regionales Ministeriales de Salud, or SEREMI de Salud). MINSAL is the central public-health authority and is responsible for issuing health policies, regulations and decrees, and for setting the general regulatory framework applicable across these sectors.

For medicinal products, the ISP is the main technical and regulatory authority. Through its medicines area, including ANAMED, it is responsible for sanitary registrations, clinical-trial oversight, quality control, inspections, regulatory surveillance and post-marketing vigilance, including pharmacovigilance.

For medical devices, the ISP also acts as the principal technical authority, through its specialised devices area (currently ANDIM), and is responsible for registration or other pre-market control where applicable, market surveillance, technovigilance, and related regulatory oversight.

For food, including food supplements, the competent enforcement authorities are primarily the SEREMI de Salud, which are responsible for sanitary authorizations of establishments, inspections, and regional enforcement. Food supplements are generally treated as food products rather than as medicinal products and, as such, fall principally within the competence of the SEREMI; however, where a classification issue arises, the ISP may intervene to determine whether the product should instead be treated under the pharmaceutical regime.

In Chile, regulatory decisions concerning medicinal products, medical devices, and food supplements may be challenged through both administrative and judicial avenues. The applicable remedies depend on which authority issued the challenged act, as two distinct bodies exercise regulatory competence in this field.

I. Medicinal products and Medical Devices — Instituto de Salud Pública (ISP)

The ISP is the competent authority for the registration, authorization, and control of medicinal products and medical devices.

Administrative remedies:

•  Reconsideration (reposición): Filed before the ISP itself within five business days of notification of the challenged decision, pursuant to Article 59 of Law N° 19.880.
• Special claim before the Minister of Health (reclamación): Under the Health Code, any act or resolution of the ISP Director in matters governed by the Health Code — with the sole exception of sentences handed down in sanitary summary proceedings (sumarios sanitarios) — may be challenged before the Minister of Health within five business days of notification. This special claim is not a hierarchical appeal (recurso jerárquico) in the technical sense. The ordinary hierarchical appeal is expressly excluded by Article 59(4) of Law N° 19.880, which provides that no hierarchical appeal lies against acts of the heads of decentralised public services — a category to which the ISP belongs.
• Extraordinary review (revisión extraordinaria): Available on the limited grounds set out in Article 60 of Law N° 19.880 (e.g., essential documents withheld by force or fraud, bribery, or newly discovered evidence).
• Invalidation (invalidación): The ISP may also invalidate its own acts ex officio under Article 53 of Law N° 19.880, provided the affected party is notified and given an opportunity to be heard beforehand.
• Request for clarification (aclaración): Available for the correction of ambiguities, omissions, or obvious errors in the administrative act, pursuant to Articles 10 and 62 of Law N° 19.880.

Judicial remedies:

• Judicial claim under Article 171 of the Health Code: Against sanctions imposed by the ISP following a sanitary summary proceeding, a judicial claim (reclamación) lies before the competent civil court within five business days of notification of the sanctioning resolution. The court hears the matter in a brief and summary procedure and must dismiss the claim if the facts are established in the sanitary summary, if they constitute an infringement of health regulations, and if the sanction applied corresponds to the infraction.
• Constitutional protection action (recurso de protección): Before the competent Court of Appeals, within thirty calendar days of the act or from the time the affected party became aware of it. This action lies where the challenged act is alleged to infringe fundamental rights guaranteed by Article 19 of the Constitution. In practice, courts might rejected protection actions where the ISP acts within its legal competence, so this remedy has limited practical utility in the regulatory context absent a clear and direct violation of constitutional rights.
• Public-law nullity action (nulidad de derecho público): Broader judicial challenges seeking annulment of unlawful administrative acts may also be available before the ordinary civil courts under general public-law principles, where the act is alleged to have been issued without legal authority or in manifest violation of the law.
• Authorisation of certifying entities (medical devices): The ISP authorises and supervises the entities that perform quality control and certification of medical devices. Entities whose applications for authorisation are denied or not answered within the statutory period may file a claim before the Minister of Health within fifteen business days.
• Rejection of quality conformity (medical devices): Where a product is rejected by an authorised certifying entity, the manufacturer or importer may file a claim before the ISP Director within fifteen business days of notification of non-conformity. The ISP must notify the certifying entity, which has ten business days to submit its report, after which the ISP Director may resolve the claim.
• Sanctions for infringements: Sanitary summary proceedings for infringements of the medical devices regime are conducted by the competent SEREMI de Salud. The judicial remedy against sanctions is the claim under Article 171 of the Health Code (five business days), and the constitutional protection action (thirty calendar days) remains available.

Food supplements are regulated as foodstuffs under the Reglamento Sanitario de los Alimentos (DS N° 977/1996). Two authorities may be involved depending on the nature of the act challenged.

II. Food supplements — SEREMI de Salud

Under Article 103 of the Health Code, the SEREMI de Salud is the authority responsible for authorising and supervising establishments involved in the production, processing, packaging, storage, distribution, and sale of food products within its territory. Infringements of the food regulations are sanctioned by the SEREMI.

Administrative remedies:

• Reconsideration (reposición): Filed before the same SEREMI within five business days of notification, pursuant to Article 59 of Law N° 19.880.
• Hierarchical appeal (recurso jerárquico): not available. The Contraloría General has consistently held that the hierarchical appeal is inadmissible against SEREMI resolutions issued in the exercise of their desconcentrated and exclusive sanctioning and supervisory powers, since those powers are vested directly in the SEREMI and not in the Ministry of Health. The reposición therefore exhausts the administrative avenue.
• Where the challenged act is not a sanction but rather an ISP resolution determining whether a product should be classified as a food supplement, a medicinal product, or another category the remedies are those applicable to ISP acts described above: reposición before the ISP and reclamación before the Minister of Health, both within five business days.

Judicial remedies:

• Judicial claim under Article 171 of the Health Code: same as above.
• Constitutional protection action: same as above.

Clinical trials in Chile are governed by Law No. 20,120/2006 (Scientific Research on Human Subjects), its implementing regulations (Supreme Decree No. 114/2010), and the Health Code (through the Ricarte Soto Law, which added the section titled “On clinical trials of Pharmaceuticals Products and medical devices” to the Health Code).

Every trial requires: (i) provisional use authorization from the ISP (ANAMED), accompanied by a bilingual protocol, Investigator’s Brochure, informed consent approved by an accredited Scientific Ethics Committee (CEC), and the manufacturer’s GMP certificate; (ii) a favorable report from an CEC accredited by the MINSAL (Art. 10, Law 20.120); and (iii) the participant’s prior, express, free, and informed consent, revocable at any time (Art. 11, Law 20.120). Trials must be conducted in accordance with ICH E6 Good Clinical Practice, subject to inspection by the ISP at any time. The sponsor must report serious adverse events to the ISP’s CENIMEF within a maximum of 15 calendar days. For medical devices, analogous principles apply under D.S. No. 3/2010 and ISO 14155, supplemented by the ISP’s Clinical Evaluation Guide (Resolution No. 499/2021) and Law No. 21,278/2020 for trials during public health alerts. Unauthorized research is punishable by a 3-year suspension from professional practice and an absolute ban in the event of a repeat offense (Art. 20, Law 20.120).

Importantly, Article 111 C of the Health Code grants clinical trial participants the right to continue receiving the investigational treatment at no cost after the trial concludes, for as long as the treatment retains therapeutic utility as determined by the research protocol. This obligation binds both the holder of the provisional authorization and, subsequently, the marketing authorization holder.

Additionally, Article 111 M requires manufacturers and importers of sanitary products to maintain insurance, a bond, or equivalent financial guarantee to cover health damages arising from safety issues, under terms to be established by regulation.

Chile does not have its own national database of clinical trials equivalent to ClinicalTrials.gov (U.S.) or the EU Clinical Trials Register (EU). However, Article 111A of the Health Code requires the ISP to maintain a public registry of research studies authorized in the country. In compliance with this regulation, the ISP publishes on its website (www.ispch.cl) lists of authorized clinical trials, including basic identifying information (protocol number, sponsor, study phase, therapeutic indication, and research centers), although without the level of detail and functionality found in international registries.

The use of clinical trial data in Chile is governed by three overlapping legal frameworks:

(i) Personal data protection: Health data is considered sensitive data under Article 2(g) of Law No. 19,628/1999 and Law No. 20,584/2012, and its processing requires the data subject’s express consent. Law No. 21,719/2024 (which takes effect on December, 2026) reinforces this protection with principles of purpose limitation, proportionality, pseudonymization, and encryption. Genetic data must be encrypted (Art. 13, Law 20.120), and its unauthorized use is subject to criminal penalties (Art. 18).

(ii) Consent and limitation of use: Art. 11 of Law No. 20.120 requires prior, express, free, and informed consent, which may be revoked at any time. Supreme Decree No. 114/2010 requires that samples and data be used exclusively for the purposes for which they were obtained.

(iii) Trade confidentiality and data exclusivity: the Health Code grants the ISP unrestricted access to all research information, and any confidentiality clause is unenforceable. However, test data for new chemical entities enjoy exclusivity for 5 years pursuant to Art. 89 of Law No. 19,039 (DFL No. 3/2006) and D.S. No. 107/2008, during which time the ISP may not use such data to approve third-party products, except in cases of public health, compulsory licensing, or anti-competitive conduct (Art. 91).

Chile is making tentative but growing progress in the digitization of clinical trials.

Regarding decentralized clinical trials (DCTs), there is no specific regulation, but Supreme Decree No. 6/2022 (Regulations on Remote Healthcare) expressly recognizes that remote services may be part of scientific research projects in accordance with Law No. 20,120, requiring that patient information be used “dissociated or anonymized in accordance with Law No. 19,628, unless the patient’s express written consent is obtained.” Law No. 21,541/2023 (Telemedicine) complements this framework by regulating remote healthcare, facilitating the digital monitoring of participants. Finally, the interoperability of electronic health records promoted by MINSAL (HL7 FHIR standard) could facilitate recruitment and monitoring in clinical trials, although there is not yet a specific legislative proposal regarding the comprehensive digitization of trials.

Regarding medicinal products, manufacturing may only take place in pharmaceutical laboratories expressly authorized by the ISP (Art. 127, Health Code; Arts. 107–114, Supreme Decree No. 3/2010). Authorization requires compliance with Good Manufacturing Practices (GMP), the appointment of a pharmaceutical chemist as Technical Director, and separate heads of production, quality assurance, and quality control, as well as a satisfactory on-site inspection. The ISP must decide on the application within 30 business days and may inspect the facilities at any time. For pharmaceutical establishments (pharmacies, drugstores, pharmaceutical warehouses, and storage facilities), Article 10 of Supreme Decree No. 466/1984 further requires submission to the ISP of: an application identifying the owner and Technical Director, a statement from the pharmacist who will assume technical management, and a copy of the documents proving ownership of the establishment.

Regarding medical devices, manufacturers must obtain a certificate of conformity issued by entities authorized by the ISP, when applicable (see answer #2). Devices are classified into four risk classes (I–IV), with progressively stricter regulatory requirements. No device may be manufactured or distributed without the corresponding certificate. SEREMI and ISP has the authority to impose penalties for violations.

Regarding Food and food supplements, food establishments require authorization from the relevant SEREMI (Art. 103, Health Code; Arts. 6 and 9, D.S. No. 977/1996), which is granted following an inspection within 30 business days. Facilities must comply with Good Manufacturing Practices (Art. 69, D.S. No. 977/1996). Pharmaceutical laboratories already authorized by the ISP are automatically deemed authorized to manufacture food supplements without additional permission (Transitory Art., D.S. No. 287/2002).

Regarding medicinal products, wholesale distribution is carried out through pharmacies authorized by the Regional Ministry of Health (SEREMI), which must strictly comply with ISP Technical Standard No. 147 on Good Storage and Distribution Practices (BPAD). These facilities require a Technical Director who is a licensed pharmacist and systems that ensure traceability and the cold chain (D.S. No. 3/2010; D.S. No. 466/1984). Retail distribution is limited to pharmacies, pharmaceutical warehouses, and first-aid kits. Pharmacies must have a licensed pharmacist on staff at all times. In the public sector, CENABAST centralizes procurement through tenders and distributes to the healthcare network and participating pharmacies (Art. 70 bis, DFL No. 1/2005).

Regarding food supplements, there is no specific licensing regime for food supplement distributors. Their distribution is governed by the general provisions of the Food Safety Regulations (Supreme Decree No. 977/1996) regarding storage, transportation, and safety. They may be sold in pharmacies, supermarkets, and specialty stores without any channel restrictions, provided they comply with the RSA’s labeling requirements, including the mandatory statement “food supplement” and usage warnings (Art. 537, D.S. No. 977/1996, as amended by D.S. No. 287/2002).

Chile does not have a general system for the regulation or price-setting of medicines, medical devices, or food supplements. However, a set of specific legal frameworks introduces meaningful pricing transparency obligations and public procurement mechanisms, that collectively shape the regulatory landscape.

I. Medicinal Products

1. Price Transparency Obligations

While Chile does not impose price controls on pharmaceuticals as a general rule, the legal framework establishes comprehensive transparency obligations throughout the supply chain, namely:

• Manufacturers, importers, and distributors are required to publicly disclose the prices of the products they sell and any volume discounts applied, specifying each discount tier.
• Pharmacies and other authorized dispensing establishments must inform consumers of the price of each product in a clear, timely, and verifiable manner. Each establishment must maintain a permanently updated, publicly accessible price list — available in printed or electronic format — containing, for each product: the International Nonproprietary Name (INN), dosage, brand name (if any), marketing authorization holder, presentation, unit price, and bioequivalence status. Products must be listed grouped by active ingredient and dosage.
• All medicines available for sale must display their price on the packaging.
• CENABAST (Central Supply Agency of the National Health Services System) is also required to publish and keep updated the prices of all products it supplies, including applicable volume discounts.

2. CENABAST: Public Procurement and Maximum Retail Price Setting

CENABAST is the public body responsible for supplying medicines, pharmaceutical articles, and other health inputs to the public health system. Its role has two distinct dimensions:

(a) Public sector procurement: CENABAST consolidates public sector demand in its negotiations with the pharmaceutical industry, thereby leveraging purchasing power to obtain more favorable prices for the public health system. CENABAST is required to publish and maintain updated prices for all products it supplies.

(b) Private channel intermediation and maximum retail price setting: Law No. 21,198 significantly expanded CENABAST’s role by authorizing it to intermediate medicines directly to private pharmacies, non-profit health establishments, and community pharmacies. Under this mechanism:

• A Consultative Council — composed of representatives of the ISP (Public Health Institute), the Ministry of Health, CENABAST, and economists with expertise in regulated markets — recommends the maximum retail price applicable to medicines intermediated by CENABAST.
• At the time of sale to the pharmacy, CENABAST determines the maximum retail price that the purchasing establishment may charge consumers for each intermediated product.
• Maximum prices for intermediated products must be disclosed separately from other products in the pharmacy’s price lists.
• All sales made under this mechanism must be published on CENABAST’s institutional website, with an annual report detailing the transactions.

This represents the most direct form of price regulation in the Chilean pharmaceutical market, albeit limited to medicines acquired through CENABAST’s intermediation scheme.

Finally, regarding medicines and medical devices, Law No. 20,850 — which establishes a financing system to guarantee access to high-cost treatments for low-prevalence diseases (known as the “Ricarte Soto Law”) — introduced rules that, while not fixing prices outright, do regulate them in meaningful ways:

• Maximum industrial price (precio máximo industrial): This concept, introduced by Law No. 20,850, refers to the maximum value the State will pay for a technology incorporated into the special financial coverage system. This price is determined during the scientific evidence evaluation process that precedes the decision by competent authorities on which health conditions and treatments will be covered under the system.
• Risk-sharing agreements: Law No. 20,850 explicitly recognizes the State’s option to enter into risk-sharing agreements with special payment conditions as a financing mechanism for technologies included in the protection system. This allows for flexible arrangements where reimbursement is tied to real-world clinical outcomes.

1. Medicinal Products (Pharmaceuticals)

The advertising of pharmaceutical products in Chile is primarily governed by D.F.L. N° 1/2005 (Health Code), D.S. N° 3/2011 — which contains a dedicated Title on “Advertising and Information” (Arts. 199 et seq.) —, along with the regulations issued by the Instituto de Salud Pública (ISP) through its agency ANAMED (Agencia Nacional de Medicamentos).

The central regulatory distinction is based on the prescription status of the product:

• Prescription-only medications (Rx): Their advertising to the general public is expressly prohibited. Only promotional activities directed at healthcare professionals authorized to prescribe them are permitted. Such promotion may not, under any circumstances, be carried out through mass media or any channel accessible to the general public (Art. 97, D.F.L. N° 1/2005).
• Over-the-counter medications (OTC / venta directa): Advertising to the general public is permitted, but subject to prior authorization by the ISP (ANAMED). All advertising must be strictly consistent with the patient information leaflets and labels approved in the corresponding registro sanitario (sanitary registration). Claims that go beyond the approved indications, dosages, or conditions of use are prohibited.

Article 207 A of D.S. N° 3/2011 establishes that liability for unauthorized advertising extends beyond the registration holder to all natural or legal persons who participate in the dissemination of such advertising and without whose involvement it could not have been carried out. This provision is particularly relevant for media outlets, advertising agencies, and digital platforms.

The power to suspend or prohibit advertising that fails to comply with the applicable regulations rests exclusively with the ISP, acting by means of a reasoned resolution (Art. 203, D.S. N° 3/2011). The ISP may also order the immediate cessation of the activity, without prejudice to the corresponding sanitary summary proceeding (sumario sanitario).

In all cases, advertising must be truthful, balanced, and must not induce therapeutic errors or encourage irrational use of medicines.

2. Medical Devices

There is no specific statute in Chilean law dedicated exclusively to the advertising of medical devices. Medical devices are regulated primarily by D.S. N° 825/1998 (Reglamento de Control de Productos y Elementos de Uso Médico), published in 1999, and supervised by ANAMED/ISP.

A key provision of D.S. N° 825/1998 is that the concept of “intended purpose or use” (finalidad o uso previsto) of a medical device is defined as the utilization to which the device is destined according to the indications provided by the manufacturer in the labeling, instructions for use, and/or advertising material (Art. 1).

From the general health regulatory framework, the following principles apply:

• Advertising may not attribute properties, indications, or characteristics to a medical device that are not included in its certificado de registro or the technical documentation submitted for its sanitary authorization.
• Advertising must not mislead consumers regarding the intended use, performance, or safety of the device.
• Any off-label promotional claims or exaggerated therapeutic attributions would be inconsistent with the principles of the Health Code and could expose the advertiser to regulatory and civil liability.

Food supplements in Chile are regulated as food products under D.S. N° 977/1996 (Reglamento Sanitario de los Alimentos — RSA), as amended by D.S. N° 287/2002, supervised by the Ministerio de Salud (MINSAL) and the Servicio Nacional de Aduanas for imported products. There is no specific regulatory framework dedicated exclusively to the advertising of food supplements; however, the following key restrictions apply:

a) Prohibition of therapeutic, preventive, or curative claims

The RSA expressly prohibits promoting the consumption of food supplements “for purposes of diagnosis, prevention or treatment of diseases.” Such attributes are exclusive to pharmaceutical products duly registered before ANAMED. This is a critical regulatory boundary: a supplement marketed with disease-prevention or treatment claims may be reclassified as a pharmaceutical product by the ISP, triggering all associated regulatory requirements including sanitary registration.

b) Advertising and labeling requirements

All food supplements must indicate in their labeling, prominently on the main face of the packaging and immediately following the product name, their classification as “suplemento alimentario” (food supplement). They must also include, immediately below this classification, a mandatory warning legend stating that the product is not recommended for children under 8 years of age, pregnant women, or nursing mothers, unless indicated by a competent professional, and that it does not replace a balanced diet.

c) Nutritional and functional claims

Declarations of health and nutritional properties, as well as supplementary nutritional information described on the packaging, must comply with the standards established in the RSA for such purposes. Nutritional declaration is mandatory.

4. Cross-Cutting Legislation

Regardless of the product category, all advertising in Chile is subject to the following horizontal frameworks:

a) Ley N° 19.496 (Consumer Protection Act)

Prohibits misleading advertising (publicidad engañosa) and unfair commercial practices. Enforcement lies with the SERNAC (Servicio Nacional del Consumidor), which may initiate collective proceedings or refer cases to the courts. It is important to note that in matters involving technical health and safety standards, the special sanitary regulatory framework takes precedence over the general consumer protection statute.

b) Ley N° 20.606

Imposes restrictions on the advertising of foods required to bear warning seals (sellos de advertencia) due to high content of calories, sodium, sugar, or saturated fat. Advertising of such products directed at children under 14 years of age is expressly prohibited. This law does not apply to food supplements, which remain subject to D.S. N° 977/1996.

c) Ley N° 20.869 on Food Advertising

This law complements Ley N° 20.606, which introduced further amendments to the RSA. Its key provisions include:

• Broadcast time restrictions: No advertising of foods bearing warning seals may be broadcast on cinema or television services between 06:00 and 22:00 hours (Art. 110 ter, RSA, as amended).
• Absolute prohibition on advertising of breast milk substitutes: All advertising of infant formula (fórmulas de inicio) and follow-on formula (fórmulas de continuación) for children up to 12 months of age is absolutely prohibited, regardless of the medium or time of broadcast (Art. 497 bis, RSA, as amended).

As with Ley N° 20.606, these restrictions apply to food products bearing warning seals and do not directly govern food supplements, which remain subject to the specific regime of Arts. 536–537 of the RSA

In Chile, the primary legal framework governing patents and trademarks for medicinal products, medical devices, and food supplements is Law No.19.039 on Industrial Property along with its implementing Regulation approved by Supreme Decree No. 82 of 2022 of the Ministry of Economy, Development and Tourism. Both instruments are administered by the National Institute of Industrial Property (INAPI).

With respect to patents, Law No.19.039 protects inventions that are novel, involve an inventive step, and are industrially applicable. Patents for medicinal products, medical devices, and food supplements are subject to the general patent regime, which grants protection for a term of 20 years from the filing date, non-renewable. The patent confers on its holder the exclusive right to produce, sell, commercialize, or otherwise exploit the patented subject matter.

Supplementary protection for pharmaceutical products is available under Law No. 19.039, providing two distinct mechanisms for supplementary protection, both triggered exclusively by unjustified administrative delays — not by the mere duration of the relevant proceedings:

• Article 53 bis 1 — Delay in patent grant: Where the patent granting process involved an unjustified administrative delay and the total time exceeded five years from the filing date or three years from the request for examination (whichever is later), the patent holder may request supplementary protection. The request must be filed within 60 days of the grant of the patent.
• Article 53 bis 2 — Delay in sanitary registration of a pharmaceutical product: Where the sanitary registration of a pharmaceutical product covered by a patent involved an unjustified delay, and the registration process took more than one year from the date of filing of the sanitary registration application, the patent holder may request supplementary protection for the part of the patent covering that product. The request must be filed within 60 days of the grant of the sanitary registration. The supplementary protection extends only for the period attributable to the unjustified delay.

In both cases, the supplementary protection extends only for the period accrued as unjustified delay; the extension is strictly commensurate with the demonstrated unjustified delay. Delays attributable to the complexity of the technical review, the need to obtain reports from national or international agencies, or the volume of documentation submitted might be treated as justified delays and therefore do not give rise to supplementary protection.

A defining feature of the Chilean system is the complete absence of a formal patent linkage mechanism. The ISP is not empowered to deny, suspend, or condition the grant of a sanitary registration on the existence of a patent covering the relevant product. Article 19 of Supreme Decree No. 3 of 2010 expressly provides that the administrative act of sanitary registration is independent of the commercial, intellectual property, or industrial property aspects of those who apply for or obtain it, in the terms set out in Article 49 of Law No. 19.039. Consistently, this sanitary registration grants the title holder no authorization for commercialization without consent from the patent holder; and the patent holder’s remedies lie in infringement actions before the competent courts, not in the sanitary registration process.

Under Article 89 of Law No. 19.039, when the ISP requires the submission of test data or other undisclosed information relating to the safety and efficacy of a pharmaceutical product that uses a new chemical entity not previously approved by the competent authority, such data are treated as confidential. The ISP may not disclose or use those data to grant a registration or sanitary authorization to a third party without the titleholder’s consent for a period of five years for pharmaceutical products, counted from the first sanitary registration granted by the ISP.

This protection is not automatic. Pursuant to Supreme Decree No. 107 of 2008 of the Ministry of Health — which regulates the procedural mechanisms for the ISP’s compliance with Article 89 — the applicant must expressly request data protection at the time of filing the sanitary registration application, and must submit a separate, consecutively paginated copy of the undisclosed data sought to be protected

Medical devices — defined under Article 111 of the Health Code as instruments, apparatus, devices, and other articles or elements intended for the diagnosis, prevention, and treatment of human diseases, or for the replacement or modification of human anatomy — are subject to a quality control and certification regime, distinct from the sanitary registration applicable to pharmaceutical products.

Manufacturers, importers, distributors, and commercializers of medical devices must obtain quality certification from entities expressly authorized by the ISP. The ISP is the body responsible for authorizing and supervising those certification entities. This regime does not involve a sanitary registration in the strict sense applicable to pharmaceutical products, which has two relevant consequences for industrial property purposes:

• The five-year data exclusivity protection under Article 89 of Law No. 19.039, which is framed around “sanitary registration” of pharmaceutical products, does not expressly apply to medical devices. This creates an asymmetry in the level of data protection available.
• The supplementary patent protection mechanism of Article 53 bis 2, which is triggered by delays in the “sanitary registration” of a pharmaceutical product, is also not directly applicable to medical devices under the current statutory framework.

The general patent regime of Law No. 19.039 applies fully to inventions embodied in medical devices, subject to the standard requirements of novelty, inventive step, and industrial applicability.

With respect to trademarks, Law No. 19.039 and Supreme Decree No. 82 of 2022 apply equally to trademarks for medicinal products, medical devices, and food supplements. Under Article 19, any sign capable of distinguishing products or services in the market may be registered as a trademark, including words, figurative elements, and mixed signs. Trademark protection is granted for ten-year renewable terms, indefinitely renewable.

Article 20 of Law No. 19.039 prohibits the registration as a trademark of signs that lack distinctiveness or that consist exclusively of common or generic names of the relevant goods. As a consequence, International Nonproprietary Names (INNs) cannot be monopolized through trademark registration, nor can signs that are confusingly similar to them.

The sanitary registration requirements administered by the ISP impose parallel naming and labeling obligations that directly condition the use of trademarks on product packaging. Under Supreme Decree No. 3 of 2010, where a medicinal product carries a trade name, the INN must appear immediately below the trade name in a specified font size. This mandatory co-display requirement limits the extent to which a brand name can be presented prominently relative to the generic denomination.

Law No. 20.724 of 2014, which amended the Health Code, further reinforced the role of the INN in the pharmaceutical market by strengthening the obligation to use the DCI in medical prescriptions and by requiring pharmacists to offer patients the option of a bioequivalent product where one exists. These obligations operate independently of trademark rights but have a practical impact on the commercial value and visibility of pharmaceutical trademarks.

Patent infringement in Chile is primarily addressed through civil proceedings before the ordinary civil courts. Pursuant to Article 107 of Law No. 19.039, civil infringement actions are conducted under the summary procedure (procedimiento sumario) of the Code of Civil Procedure — not the ordinary procedure. This entails shorter timeframes and a more concentrated procedural structure. Evidence is assessed by the court under the rules of sana crítica (reasoned judicial discretion), as provided by Article 111 of Law No. 19.039.

In the pharmaceutical and medical device sectors, infringement typically takes the form of: (i) manufacturing, using, selling, or importing a patented product or a product directly obtained by a patented process without authorization; (ii) commercially launching a generic medicine or a competing medical device that falls within the scope of a patent’s claims before the patent has expired and without authorization from the patent holder. It is important to note in this regard that, under Law No. 19.039, obtaining sanitary registration for such a product prior to patent expiry does not in itself constitute infringement. Infringement arises only at the point of unauthorized commercialization; or (iii) indirect infringement through the supply of means essential for the implementation of a patented invention.

Under Article 106 of Law No. 19.039, the patent holder may seek the following civil remedies:

• Cessation of infringing acts and adoption of measures to prevent continuation of the infringement.
• Damages (indemnización de daños y perjuicios): Under Article 108, the plaintiff may elect among three alternative methods of quantification: (a) lost profits of the patent holder; (b) profits obtained by the infringer as a result of the infringement; or (c) the price the infringer would have paid for a license, taking into account the commercial value of the infringed right and any contractual licenses already granted. This tripartite regime is more favorable to the patent holder than the general damages rules of the Civil Code.
• Publication of the judgment at the infringer’s expense, in a newspaper chosen by the plaintiff, where the court expressly so orders.

Chilean law does not provide for punitive or statutory damages in patent cases.

An important limitation is established by Article 109 of Law No. 19.039: mere distributors (e.g., wholesalers, pharmacies) are not liable for damages unless they manufactured or produced the infringing product, or commercialized it with knowledge that they were committing an infringement. This has significant practical implications in the pharmaceutical supply chain.
Additionally, under Article 110, the court may order the infringer to disclose information about third parties involved in the production or distribution of the infringing products.

Defendants in patent infringement actions in Chile may invoke the following defenses:

1. Invalidity of the Patent

A defendant may challenge the validity of the asserted patent before INAPI (administrative nullity proceeding). Grounds for invalidity include: lack of novelty (Article 33, Law No. 19.039); lack of inventive step (Article 35); insufficient disclosure; non-patentable subject matter; or failure to comply with formal requirements. Notably, methods of medical treatment are expressly excluded from patentability under Article 37 of Law No. 19.039, which is a frequently invoked ground in the pharmaceutical sector.

2. Non-Infringement

The defendant may argue that the product or process does not fall within the scope of the patent claims.

3. Exhaustion of Rights

Once a patented product has been lawfully introduced into commerce in any country by the patent holder or with its consent, the patent does not confer the right to prevent its subsequent commercialization.

4. Research and Experimental Use

Under Article 49 of Law No. 19.039, the patent does not confer the right to prevent third parties from importing, exporting, manufacturing, producing, or using the patented matter for the sole purpose of obtaining sanitary or regulatory authorization for a pharmaceutical, agro-chemical, or other product. This provision permits generic manufacturers and biosimilar developers to conduct the trials, tests, and studies necessary to obtain sanitary registration before patent expiry, without such activities constituting infringement. The same article also excludes from infringement: acts carried out privately and without commercial purpose; acts carried out for exclusively experimental purposes relating to the subject matter of the patented invention; and the preparation of medicines under medical prescription for individual cases.

5. Compulsory Licensing

In cases involving public health emergencies or situations of national interest, the Ministry of Health may issue a declaration of public health grounds that enables the granting of a compulsory (non-voluntary) license over a patent, pursuant to Article 51 of Law No. 19.039. The TDLC (Competition Tribunal) has jurisdiction over compulsory licenses sought on grounds of abuse of dominant position or anticompetitive conduct. A granted compulsory license constitutes a complete defense to an infringement action within its scope.

6. Prior Use Rights

A person who was already using the invention in good faith, or had made effective and serious preparations for such use, prior to the filing date of the patent application in Chile (or the validated priority date) may continue such use within the limits of the existing activity. This right is personal and non-transferable, except together with the business in which the prior use was made.

Chilean law does not establish sector-specific prohibitions on the use of trademarks for medicinal products, medical devices, food, or food supplements beyond the general restrictions applicable to trademark registration under Law No. 19.039 (Industrial Property Law, consolidated text DFL No. 4 of 2022). However, several regulatory regimes impose significant practical constraints on the use of trademarks in these sectors that interact materially with trademark rights.

The Industrial Property Law establishes a set of absolute grounds for refusal, one of them particularly relevant for health-related and food products. Article 20 of Law No. 19.039 prohibits the registration as trademarks of technical or scientific denominations, names of plant varieties, common denominations recommended by the World Health Organization (i.e., International Nonproprietary Names or INNs), and denominations indicative of therapeutic action. This is the most directly relevant prohibition for pharmaceutical and health products, as it expressly bars the monopolization of INN-derived names and any sign that evokes a therapeutic effect.

Additionally within the sanitary registration process, medicinal products may not be designated with a fantasy name in the following cases:

• The name is identical or similar to an INN, a chemical or generic denomination of the active ingredient(s).
• The name may induce confusion, being identical or similar to the name of another registered product with a different active ingredient or different therapeutic properties.
• The name was previously used to identify a product whose registration was cancelled or expired, unless 10 years (for over-the-counter products) or 5 years (for other products) have elapsed, and the therapeutic properties differ — unless it is proven the product was never commercialized.
• The name covers or is similar to the name of a food, cosmetic, or other product subject to sanitary control — a cross-sector restriction that creates a regulatory boundary between the pharmaceutical and food/cosmetic trademark spaces.
• The name induces incorrect use or encourages self-medication.

Where a pharmaceutical specialty containing a single active ingredient is identified by a fantasy name, the generic name must appear on the label in characters of no less than 50% of the size of the authorized denomination, immediately below it, in uppercase letters, and with the same color and background. This is a direct restriction on the visual use of the trademark in packaging and labeling: the brand name cannot be presented in a manner that visually dominates the generic name beyond this ratio.

The product liability regime for defective health products is set out in Title VI of Book IV of the Chilean Health Code (Código Sanitario), Articles 111H through 111N, as introduced by Law No. 20,850 of 2015. This regime covers the health products regulated under Titles I, II, and IV of that same Book, encompassing medicinal products, medical devices, and food supplements or medically-indicated foodstuffs bearing a health registration. Products regulated under Title III of Book IV — primarily cosmetics and personal hygiene products — fall outside the scope of this specific regime.

Under Article 111H of the Health Code, a health product is considered defective on either of two independent grounds:

(i) Insufficient safety: the product fails to provide the level of safety that the public is entitled to expect, taking into account all circumstances relating to the product, and in particular its presentation and its reasonably foreseeable use; or

(ii) Series defect: the product does not offer the same level of safety normally offered by other units of the same series (“si no ofrece la misma seguridad normalmente ofrecida por los demás ejemplares de la misma serie“).

The second ground is of particular practical relevance in batch or series defect cases — for instance, where a manufacturing fault affects a specific production lot — and operates independently of the general safety expectation test. In both cases, a product may not be deemed defective solely on the ground that a better version was subsequently placed on the market.

Chile has established a specific product liability regime for defective sanitary products (Articles 111 H through 111 M of the Health Code, as introduced by Law No. 20.850). This regime imposes liability on registration holders, manufacturers, and importers, who are jointly and severally liable for damages caused by defective sanitary products (Article 111 I).

While the regime excludes the state-of-the-art defense—meaning that defendants cannot avoid liability by arguing that the defect was unforeseeable given the scientific or technical knowledge at the time of placing the product on the market (Article 111 K)—it does not constitute strict liability in the purest sense. The claimant bears the burden of proving three elements: (i) the defect, (ii) the damage, and (iii) the causal link between them (Article 111 J). The claimant is not required to prove fault or negligence.

Article 111I of the Health Code identifies three categories of parties that may be held liable, each in their own right and independently of the others: (i) Holders of health registrations or authorisations (titulares de los registros o autorizaciones); (ii) manufacturers; and (iii) importers.

All responsible parties are jointly and severally liable (solidariamente) before the injured person. Any party that has paid compensation to the injured person has the right to seek reimbursement (acción de repetición) from the other responsible parties, in proportion to their contribution to the harm.

The primary damages claim must be filed within a five-year period, counted from the date on which the defect or the resulting damage became manifest. These rules constitute a departure from the general limitation periods under Chilean civil law.

The reimbursement action (acción de repetición) brought by a paying party against the other jointly liable parties prescribes after two years from the date of payment of the compensation.

Manufacturers and importers of health products are required by Article 111M of the Health Code to maintain insurance, a bond, or an equivalent financial guarantee in favour of third parties. This obligation is designed to ensure that victims can effectively recover compensation regardless of the financial position of the responsible parties.

The exercise of jurisdictional actions for damages is governed by the procedure set out in Paragraph II of Title III of Law No. 19,966, which includes a mandatory prior mediation stage before judicial proceedings may be initiated. The mediation procedure operates differently depending on whether the defendant is a public or private entity:

Where the claim is brought against a public institutional health provider (or its staff), the claimant must first submit the claim to a mediation procedure before the Consejo de Defensa del Estado (CDE). During the mediation period, the prescription period for both civil and criminal actions is suspended.

Where the claim is brought against a private health provider, the claimant must submit to a mediation procedure before a mediator accredited by the Superintendencia de Salud. The costs of private mediation are borne by the parties.

In all cases, mediation is a non-adversarial procedure aimed at facilitating a direct, extrajudicial resolution between the parties. If mediation fails or is declared to have failed, the claimant may proceed to judicial action. Any agreement reached in mediation takes effect as a settlement contract (contrato de transacción), which in the case of public-sector defendants requires approval by the CDE (and, for amounts exceeding 3,000 UF, by the Ministry of Finance).

Special rules for clinical trials: Article 111J paragraph 2 establishes a presumption of causation in the context of clinical trials: once damage is proven, it is presumed to have occurred with occasion of the research (“se presumirá que éste se ha producido con ocasión de la investigación“). The statute of limitations for clinical trial liability is 10 years from the manifestation of the damage, compared to 5 years for defective product claims (Article 111 L).

Regarding regulations pertaining to this topic, our country’s Penal Code defines certain crimes—such as those related to the counterfeiting and adulteration of medicinal substances—as punishable by imprisonment.

Regarding administrative liability, the Chilean Institute of Public Health may impose fines (up to 1,000 UTM, equivalent to approximately USD 75,000 based on the current UTM rate), suspension of health registration, closure of establishments, and mandatory product recalls, in accordance with the Health Code and D.S. 3/2010. The Regional Health Secretariats (SEREMI) have similar powers at the regional level.

Similarly, the Health Code includes a specific provision to regulate health liability for defective products, defined as those that do not offer sufficient safety, considering all circumstances related to the product and, in particular, its presentation and reasonably foreseeable use. Thus, it is established that the injured party must prove the defect, the damage, and the causal relationship between the two, and that the holders of registrations or authorizations, manufacturers, and importers are liable for such damage.

In addition, a group of consumers of a defective medical device may also initiate a class action to seek compensation for damages, the imposition of fines, among other remedies.

Chile has begun to develop a framework for digital health, although it is still in its early stages compared to other jurisdictions. Among these, we find the Telemedicine Law (No. 21,541/2023), which essentially regulates the provision of remote health services through information technologies, establishing requirements for telemedicine platforms, including the provider’s identity, records of care, and patient data protection.

In addition, in 2019, through Exempt Resolution No. 347 of February 2019, the Digital Hospital Department, under the Ministry of Health, was created. Its objective is to be responsible for designing, building, implementing, and operating digital health solutions that ensure timely and high-quality access to healthcare, expand service hours, help reduce waiting lists, and provide greater efficiency to the country’s primary care centers.

In this context, the Personal Data Protection Act (Law No. 21719) was enacted in 2024, which classifies health data as sensitive data, strengthens security obligations regarding such data, and establishes the Personal Data Protection Agency. This Act will take effect in December 2026.

Chile has implemented various measures to ensure the availability of medicines and medical devices. Rather than a single dedicated statute, the framework is built across several laws, regulations and administrative instruments.

In this regard, the Health Code requires the Ministry of Health to maintain a National Formulary of Essential Medicines and obliges all dispensing establishments to keep minimum stock levels based on that formulary.

Additionally, the National Health Services Supply Center manages public sector procurement through framework agreements and international tenders, maintaining strategic stocks of essential medicines and hospital supplies..

In case of shortage or inaccessibility, article 99 of the Health Code grants the ISP the authority to provisionally authorize the distribution and sale of pharmaceutical products without prior registration and to maintain a pre-approved list of products eligible for fast-track importation in such circumstances.

Within the Explicit Health Guarantees system (GES), regulations expressly require that more than one supplier exist for each guaranteed medicine, precisely to minimise the risk of supply disruption, and health insurers (isapres) are obliged to implement concrete measures to prevent stock shortages and ensure continuity of treatment. More broadly, the GES framework established by Law 19.966 creates explicit guarantees of access and timeliness that directly contribute to ensuring the supply of medicines to patients. The Guarantee of Access obliges both FONASA and private health insurers (isapres) to ensure the effective provision of all guaranteed health benefits — including medicines — to their beneficiaries. The Guarantee of Timeliness sets maximum waiting periods within which each guaranteed benefit must be delivered; if the primary provider fails to meet the deadline, the insurer must designate an alternative provider, and ultimately a third provider at the insurer’s cost. These guarantees are backed by an enforcement and sanctions regime.

Finally, Law No. 20,850 of 2015, which establishes a Financial Protection System in Chile for high-cost diagnostics and treatments, ensures access to and coverage of certain medications for diseases whose financial cost exceeds a specified threshold.

In summary, Chile’s supply security framework rests on: (i) mandatory minimum stock obligations for pharmacies; (ii) a centralised public procurement body (CENABAST) with extended reach into the private sector; (iii) emergency provisional authorisation mechanisms for both medicines and medical devices; (iv) explicit supply-continuity obligations within the GES guaranteed benefits system.

In Chile, the pharmaceutical industry is governed by the Code of Good Practice issued by the Chilean Chamber of Pharmaceutical Innovation (CIF), which essentially regulates matters related to sponsorships, endorsements, and donations; interactions with patients, patient organizations, and authorities; clinical trials; and transparency regarding transfers of value, among other issues.

Specifically, the Code does not explicitly regulate standards related to the marketing of medical products or devices.

Furthermore, the Council for Self-Regulation and Advertising Ethics regulates, in its Chilean Code of Advertising Ethics, the standards for advertising in the marketing of medicines, prohibiting exaggerated advertising, the use of claims that contradict scientific truth, and misleading statements about the true properties of medicines, among other conduct.

In addition to the aforementioned Codes of Conduct, the ISP has published guidelines, particularly on pharmacovigilance, that establish mandatory technical standards for holders of health registrations.

Between the relevant decisions, we find the ISP Technical Standard 0226, which mandates the implementation of a data recording system that enables the traceability of medical devices upon their receipt by institutional healthcare providers. This requirement was established specifically to facilitate the rapid identification of devices and access to them when they must be quarantined or removed from healthcare facilities due to safety concerns regarding their use.

The same authority, ISP, issued Resolution No. E679 of 2025 in February 2025, which establishes an internal procedure for the application of the reliance mechanism in the granting of marketing authorizations for biological pharmaceutical products. This means that, to facilitate the efficiency of regulatory operations, the Institute must, during the product evaluation stage, verify that the applicant has demonstrated that the same product has been approved by at least two of the major global regulatory agencies (EMA, FDA, MHRA, TGA, and PMDA), including the submission of an official approval letter issued by those agencies.

Finally, in what constitutes one of the most significant changes to the life sciences regulatory system, on March, 2026, the ISP published Technical Regulation 257 of 2026 which was approved by the MINSAL via Decree 11 of 2026, titled “Technical Regulation on Advanced Therapy Medicinal Products.” Essentially, the standard establishes a specific framework for biologically derived pharmaceutical products that represent innovations in contemporary medicine (gene therapy, somatic cell therapy, tissue engineering, and combination products). In short, the standard regulates the authorization of these products, as well as aspects of manufacturing, provisional registration, quality, and production for clinical research, among others.

On the judicial and competition front, two additional decisions are particularly significant:

The Supreme Court’s ruling in the Meroctane case (Rol N° 1788-2024, November 2024) is a landmark decision for the medical device and pharmaceutical distribution sector. Six patients suffered total vision loss in one eye following ophthalmic surgeries at a public hospital, caused by a defective batch of the medical device Perfluorooctane (Meroctane), imported and commercialized by Falc Chile Limitada. The Supreme Court confirmed the joint and several liability (responsabilidad solidaria) of four defendants — the importing company, the ISP, the hospital, and the regional health service — ordering each to pay CLP $100,000,000 in moral damages per plaintiff. The ruling establishes two critical principles for the sector: first, that an importer and distributor of medical devices bears an independent duty of quality control and cannot rely solely on regulatory authorization to discharge its liability — the failure to implement a safe and preventive procedure in the importation and commercialization of the product constitutes at least negligence under Articles 2314 et seq. of the Civil Code; second, that the ISP incurs falta de servicio (administrative fault) when it fails to adequately exercise its functions of authorization, control, and oversight of medical devices and their distributors under Articles 96 and 101 of the Sanitary Code, even where the product was not subject to mandatory sanitary registration.

Finally, the Supreme Court’s evolving jurisprudence on judicial coverage mandates for high-cost medicines (2020–2026) constitutes, in itself, a series of decisions with direct market access implications for the life sciences sector. The dominant line — ordering full coverage of oncological and rare disease treatments when vital risk is clearly documented, the medicine holds ISP registration or major agency approval, and no therapeutic alternative is offered — has been applied to drugs including Durvalumab, Trametinib/Dabrafenib, Trikafta, and Brineura. However, a notable restrictive shift has emerged in 2026: the Supreme Court has rejected protection actions where the medicine is not covered under the GES regime or Law No. 20,850 (the Ricarte Soto Law) and where the patient’s condition does not involve an imminent risk of death, as opposed to progressive deterioration or quality-of-life improvement. The Court has also incorporated a systemic argument now forming part of the majority reasoning: granting judicial access to medicines not included in statutory lists generates unjustified discrimination among patients with identical conditions and confers an undue commercial advantage to a specific pharmaceutical laboratory, distorting public health planning and procurement. Companies should therefore factor in both the judicial enforcement landscape and the Ricarte Soto Law inclusion process as parallel — and increasingly divergent — market access strategies.

Chile does not yet have a specific law on artificial intelligence. Nevertheless, there have been commendable initiatives, such as Law No. 21,668 of 2024, which amends the Law on Patients’ Rights and Responsibilities to establish the interoperability of medical records. Along the same lines, and recognizing that, in the context of the healthcare system’s digitalization, data protection is one of the main challenges, Law No. 21,719 on Personal Data Protection will take effect in December 2026. This law classifies health data as sensitive and establishes a special agency responsible for monitoring compliance and imposing sanctions for violations of the regulations.

Furthermore, Chile has taken a pioneering step in the protection of neurorights, becoming the first country in the world to enshrine them at the constitutional level. Law No. 21,383 of 2021 amended Article 19, No. 1 of the Political Constitution to establish that scientific and technological development shall be at the service of individuals and shall be carried out with respect for life and physical and psychological integrity, expressly mandating that the law shall regulate the requirements, conditions, and restrictions for its use in persons, with special regard to brain activity and the information derived therefrom. This constitutional mandate is complemented by a pending bill (Bulletin No. 13,828-19) currently under legislative review, which seeks to regulate neurorights as a specific legal category, establish protections for mental integrity against the use of neurotechnologies, and classify neurodata as sensitive personal data — a classification that would interact directly with the data protection framework introduced by Law No. 21,719. Until this bill is enacted, the constitutional provision remains programmatic in nature, and the specific prohibitions, obligations, and sanctions applicable to neurotechnology developers and researchers have yet to be defined by statute.

In addition, there have been initiatives in our country, such as the one called Salud a la VanguardIA, a joint initiative of the Ministry of Science, Technology, Knowledge, and Innovation and the Ministry of Health, which seeks to identify problems and design solutions based on artificial intelligence (AI) to improve hospital management, prioritizing public value, efficiency, and innovation in the healthcare system.

One of the key developments, in the authors’ view, in the life sciences sector in our country is reflected in the discussion and eventual passage of the Health Reform Bill (Bill No. 17,375-11), titled “Modernizes the National Health Services System; strengthens the National Health Fund; creates the National Digital Health Service; grants powers to the Chilean Institute of Public Health and the National Health Services Supply Center, and amends the regulations specified therein). One of the key aspects of the parliamentary debate has been the need to update the regulations governing medical devices, which fall under the jurisdiction of the ISP. The bill would expand the formula used to date regarding the categories of medical devices; establish the general application of the reliance method for the approval of medical devices; and expand the ISP’s authority to regulate not only the importation but also the local production of such devices.

In addition, Law 21.719/2024—which, as mentioned above, regulates the protection and processing of personal data and will take full effect in December 2026—will clearly pose new challenges for the pharmaceutical, medical device, and digital health industries in the areas of patient data management, clinical research, and pharmacovigilance. These challenges, of course, must be assessed and addressed soon by the key players in the pharmaceutical and life sciences sector in general.

A landmark development for Chile’s regulatory standing in the life sciences sector was the designation of the ISP—through its National Medicines Agency (ANAMED)—as a Level IV National Regulatory Authority (NRA) by the Pan American Health Organization (PAHO/WHO), a status Chile has held continuously since 2016 and is now approaching its tenth year. This classification, the highest tier under PAHO’s regulatory maturity benchmarking system, recognizes that Chile’s regulatory system operates at the most advanced level of performance, with fully functional, well-integrated processes and a culture of continuous improvement across all critical regulatory functions, including marketing authorization, pharmacovigilance, GMP inspections, and quality control laboratories. Nearly a decade of sustained Level IV performance places Chile among a select group of Latin American countries holding this designation. The practical implications for the life sciences industry are significant: the Level IV status underpins the reliance and recognition mechanisms that allow other national authorities in the region to rely on ANAMED’s regulatory decisions, streamlines market access for products registered in Chile, and reinforces the credibility of Chilean clinical research and pharmacovigilance data at the international level. This long-standing designation also provides the robust regulatory foundation for the expanded reliance-based approval framework proposed in the Health Reform Bill discussed above.

Chile’s incorporation of nirsevimab into its national immunization program represents another significant development at the intersection of regulatory science, public health policy, and the life sciences industry. Nirsevimab is a long-acting monoclonal antibody directed against the respiratory syncytial virus (RSV/VRS) indicated for the prevention of RSV lower respiratory tract disease in newborns and infants. Its inclusion in Chile’s publicly funded immunization program—making Chile one of the first countries in Latin America to adopt this intervention at a national level—reflects both the maturity of ANAMED’s regulatory processes and the Ministry of Health’s responsiveness to the significant disease burden caused by RSV. The incorporation of a monoclonal antibody into a national immunization program—as opposed to a traditional vaccine—is itself a regulatory and policy milestone, as it required adapting the existing immunization framework to accommodate a novel product category. This development is likely to pave the way for future discussions around the regulatory pathway and public funding of other monoclonal antibodies and, more broadly, of advanced biological products in the preventive health space.