Chile Regulatory News

Chile’s Institute of Public Health (ISP) has introduced a new sanitary control regime for tattoo inks, marking the first time the country formally categorises how these products should be regulated....

Chile’s Institute of Public Health (ISP) has introduced a new sanitary control regime for tattoo inks, marking the first time the country formally categorises how these products should be regulated. The decision was published in a newly issued Resolución Exenta E 6717/25.

Tattoo Inks Not Classified as Pharmaceuticals or Cosmetics

According to the ISP, tattoo inks, including permanent or temporary pigments inserted into the dermis, do not fall under the regulatory categories of pharmaceuticals, cosmetics or medical devices. This conclusion is based on their mechanism of action and intended purpose, which is predominantly aesthetic, though occasionally linked to reconstructive or medical uses. Despite not being classified as medical or cosmetic products, the inks must still comply with stringent colourant requirements established for pharmaceutical products in Chile. Only dyes listed on the official “Nómina de colorantes permitidos en productos farmacéuticos” may be used.

Strict Requirements for Safety, Quality and Distribution

Under the new resolution, tattoo inks must comply with all regulatory expectations applied to authorised pharmaceutical colourants, such as:

• Safety and quality standards
• Requirements for legal entry into the country
• Distribution controls
• Ongoing supervision and inspection by the health authority

The ISP also clarified that the decision applies not only to inks currently on the market but also to any substances that may be introduced in the future and that share the same characteristics and intended use.

Ban on Misleading Health Claims

The resolution reiterates existing prohibitions under Chile’s Sanitary Code on misleading advertising. Any form of promotion suggesting unauthorised health benefits or medical value for tattoo inks will be prohibited. Authorities warn that such claims could mislead the public or pose a risk to collective health.

Next Steps

The resolution orders that the new classification be published in the Official Gazette and on the ISP’s website. As of its signing on 6 October 2025, the new regime is now fully in effect.

Chile’s Ministry of Health has announced updated regulations to strengthen quality and safety controls on hypodermic needles and syringes, bringing the country’s standards in line with internation...

Chile’s Ministry of Health has announced updated regulations to strengthen quality and safety controls on hypodermic needles and syringes, bringing the country’s standards in line with international medical devices standards. According to the decree published on the 9 October 2025 in the Diario Oficial, all sterile, single-use needles and syringes sold or used in Chile must comply with the updated national technical standards, NCh2503:2021 for needles and NCh2504/1:2021 for syringes. The decree formally repeals the previous 2007 regulation (Decree 1.887 Exento) governing hypodermic devices, which is considered outdated and no longer reflect current scientific and technological developments.

New Certification Rules

The decree mandates that all products in these categories be certified by authorised bodies recognised by the Instituto de Salud Pública (ISP) before they can be manufactured, imported, or marketed in Chile. Any modification to a product’s design, materials, or intended use must also be reported to the ISP, which will determine whether new verification process is needed.

12-Month Transition Period

The new standards will come into force 12 months after publication, in October 2026. Until then, existing products certified under the previous 2007 decree may continue to be sold, though any new certifications must comply with the revised standards. Officials confirmed that oversight and enforcement will be carried out by the ISP and regional health authorities, with inspections focused on ensuring compliance with the updated norms.

For further details, you can consult the Regulation here (in Spanish)

The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed a...

The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed at ensuring the quality, safety, and efficacy of hemoderivative pharmaceuticals in the country. The decree was published in the Diario Oficial de la República de Chile and will come into effect seven months after its publication.

The standard, developed by the National Agency for Medicines (ISP) and the Department of Pharmaceutical Policies and Regulations, was created to address regulatory gaps in the oversight of raw materials used in hemoderivative products. These medications, derived from human blood or plasma, require strict quality control due to their biological nature and critical role in treating various medical conditions.

The Ministry of Health emphasized that the new regulation aligns with international commitments, including those established by the World Trade Organization (WTO). Following a 60-day public consultation period, no objections were raised at the national or international level, allowing for its swift approval.

The Norma Técnica N° 240 will serve as a complementary framework to existing pharmaceutical regulations in Chile, reinforcing sanitary oversight and regulatory standards for hemoderivative medicines. The full text of the regulation will be made available on the Ministry of Health’s official website. 

This development marks a significant step in Chile's ongoing efforts to strengthen pharmaceutical regulations and enhance patient safety by ensuring that all registered hemoderivative products meet the highest scientific and regulatory standards.

The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted throu...

The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted through Decree 5 Exempt, was promulgated on February 4, 2025, and published in the Official Gazette on February 21, 2025. The regulation will come into effect one year later, on February 22, 2026.

According to the Ministry of Health, this regulatory update aims to enhance patient safety by enforcing strict compliance with quality standards for these devices. The decree mandates that all immunohematological reagents must undergo a verification of conformity and certification process, in accordance with the following standards:

• NCh-ISO 16142/2:2021 – Essential Principles of Safety and Performance for In Vitro Medical Devices.

• Evaluation of first-lot performance – Sensitivity and specificity assessments conducted by the Chilean Institute of Public Health (ISP).

Key Provisions of Decree 5 Exempt

The new regulation establishes that:

1. Mandatory Certification: Immunohematological reagents must comply with regulatory quality and safety standards before they can be manufactured, imported, marketed, or distributed within Chile.

2. Risk Classification: These reagents are classified under risk classes C and D (III and IV), in accordance with Chilean medical device regulations.

3. Regulatory Oversight: The Institute of Public Health (ISP) will oversee the verification of conformity and certification process, ensuring adherence to the designated quality standards.

4. Post-Market Surveillance: Any modifications to the design, manufacturing process, intended use, raw materials, labeling, or performance of these devices must be reported to the ISP for further evaluation and approval.

Impact on the Healthcare Sector

This regulatory update is expected to improve patient safety, ensure blood transfusion reliability, and align Chilean medical device regulations with international standards. The Pan American Health Organization (PAHO) has strongly recommended that national regulatory authorities take responsibility for verifying the quality, safety, and efficacy of blood-related medical devices and reagents. Chile's adoption of these measures follows international trends in strengthening healthcare safety frameworks.

The public consultation process, conducted between February and April 2023, gathered input from industry representatives and healthcare professionals. This feedback contributed to refining the regulation, ensuring a smoother transition and effective implementation. The Ministry of Health encourages all stakeholders, including healthcare providers and medical device manufacturers, to review the decree and take necessary steps for compliance before the regulation comes into force in 2026. 

The implementation of Decree 5 Exempt represents a significant step toward enhancing Chile’s regulatory oversight of medical devices. For further details you can find the Decree (in Spanish) here.

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and not...

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and notification of hazardous substances and mixtures.

Following the notification process conducted in 2024, which covered industrial-use substances manufactured or imported in 2023 and 2024, the Ministry issued Resolution No. 7595 on December 30, 2024. This resolution approved a list of  over 850 notified industrial-use substances. According to Articles 295 and 296 of Supreme Decree No. 57/19, any chemical substance imported or manufactured after the notification deadline will be considered a new substance and must be notified prior to importation, production, or commercialization.

Key Definitions 

Industrial-use substances those whose intended use and application is carried out in manufacturing activity and productive processes. (D.S. 57/19, article 3)

Notification Details

For 2025, any new industrial-use substance not listed in Resolution No. 7595/2024 must be notified via an Excel form submitted to notificacion.sqi@mma.gob.cl before its importation or production.

In the case of importatition of a substance for industrial use, the notification must be made only the first time the substance is imported in 2025, regardless of the quantity imported and the estimated amount that will be imported throughout 2025.

In the case of manufacturing a substance, report will be needed whether it has been been manufactured it and placed on the market previously (but not notified) or before commencing use or marketing.

Entities must provide:

• Chemical name and common name (if applicable)
• CAS number (if available)
• Physical state
• Hazard classification and categories
• Estimated manufactured quantity or actual and estimated imported quantity for 2025
• Industrial-use purpose

For further details, visit the Ministry of Environment’s official notification platform.

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substan...

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substances, reinforcing the nation’s commitment to environmental and human health protection.

Companies that manufacture and/or import non-industrial chemical substances in Chile must submit their notifications by August 30, 2025. The process aims to establish a comprehensive database of chemical substances in use, enhancing risk management and regulatory oversight.

Who Must Notify?

Entities handling non-industrial chemical substances including manufacturers and importers are required to submit their  notifications.

What is a Non Industrial Chemical Substance ?

As defined in Decree 57, non-industrial chemicals are considered all substances whose intended use and application do not involve manufacturing activities or production processes. 

Key Dates to Remember:

• February 9, 2025: Start of the notification period
• August 30, 2025: Deadline for submission

For further details on the notification process, requirements, and necessary documentation, stakeholders are advised to consult Chile’sDecree 57 here (in Spanish). 

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resoluti...

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resolution 243), a comprehensive regulatory framework designed to enhance the safety and sustainability of pesticide use in the country. The resolution, published on January 14, 2025, introduces strict obligations for all stakeholders involved in the lifecycle of agricultural pesticides, from distributors to farmers and applicators.

A New Era for Agricultural Practices

The Resolution reflects Chile’s commitment to aligning its agricultural practices with international environmental and public health standards. By addressing critical issues such as pesticide drift, worker safety, and environmental contamination, it aims to reduce the risks associated with pesticide use while promoting sustainable farming practices. “This resolution is a milestone in our efforts to protect people and the environment,” said the Minister of Agriculture. “It ensures that our agricultural sector remains productive while adhering to the highest standard of safety and sustainability”.

Key Provisions of Resolución 243 Exenta

1. Sale and Distribution

   • Pesticides must be sold in their original, SAG-approved packaging.

   • Distributors must provide detailed documentation, including product names, SAG authorization numbers, and lot numbers.

   • Pesticides that are about to expire or that have been cancelled may only be sold with explicit buyer consent.

2. Storage Requirements

   • Pesticides must be stored in secure, restricted access facilities with proper hazard signage.

   • Inventories must be maintained, and expired products must be disposed of in accordance with SAG guidelines.

3. Handling and Application Practices 

   • Pesticides should only be handled by certified applicators with SAG credentials.

   • Equipment must be regularly maintained and calibrated to prevent leaks or dosage errors.

   • Pesticide applications must be announced 48 hours in advance, with exceptions for emergencies.

4. Worker Safety Protocols

   • Workers cannot re-enter treated areas before the re-entry period specified on the pesticide label.

   • Written authorization from the farm administration is required for re-entry.

5. Empty Container Management

   • Empty pesticide containers must be disposed of in accordance with label instructions and regulations.

   • Traceability records must be maintained to ensure proper disposal.

6. Service Providers

   • Companies offering pesticide application services must register with the SAG and comply with training and record keeping requirements.

Implications for Stakeholders

• Farmers and Distributors:
  The Resolution introduces enhanced record keeping and storage requirements, which may increase operational costs but will improve product safety and traceability.

• Applicators:
  Mandatory training and certification will raise professional standards, but may require additional time and financial investment.

• Environmental and Public Health:
  The regulation’s focus on minimizing pesticide drift, protecting pollinators, and ensuring proper disposal of containers is in line with global sustainability goals.

Enforcement and Compliance

SAG inspectors will oversee compliance through regular audits and field inspections. Violations of the Resolution will be subject to penalties under existing laws, including Decreto Ley Nº 3.557 and Ley Nº 18.755. Resolution 243 will take effect on January 20 2026, giving stakeholders 12 months to comply. Small-scale and indigenous farmers have been granted a 24-month transition period to comply with the training requirements, provided they obtain certification through government programs.

Resolution 243 Exenta represents a significant step forward in Chile’s efforts to balance agricultural productivity with environmental protection and worker safety. For further details, Resolution 243 can be found here (in Spanish).