Regulated Activities: Before this law, certain companies provided financial services without regulation, posing risks to clients. The Fintech law now regulates various activities, including:

a) Crowdfunding Platforms: Collective financial platforms connecting investors with investment projects. b) Alternative Transaction Systems: Systems for estimating, offering, or trading securities outside traditional markets. c) Credit and Investment Counseling: Providing advice on credit and investment. d) Securities Custody: Safekeeping of securities. e) Order and Securities Routing: Executing securities transactions or channeling orders to alternative systems.

Companies in these areas must register with the Chilean SEC. Existing companies can continue operations during registration processing. The SEC has published rules governing the Financial Service Providers Registry’s inscription and the Investment Counseling Service’s authorization.

Foreign companies providing services in Chile must establish residency in the country.

Open Finances the aim of the law: Open Finances involves standardized systems facilitating the exchange of financial information. The principle is client ownership of financial information, requiring permission for disclosure. It aims to broaden access to financial services, reduce reliance on centralized intermediaries, and enhance transparency and efficiency.

Participating companies must adhere to principles such as proportionality, quality, transparency, data security, indiscriminate treatment, and interoperability.

Implementation of the Law: The Fintech Law took effect on February 3, 2023, introducing reforms to various financial market regulations. Some reforms became effective immediately, while others await commission regulations within 18 months. Notable immediate reforms include:

• Client-Centric Products: Obligation for Fintech companies, banks, and others to offer products aligned with client needs, expectations, and risk tolerance.
• Prohibition of Misleading Information: Entities are prohibited from causing error inducement or public confusion in their information, advertisements, or publicity.
• Expanded Trading Opportunities: Changes allowing commodity brokers to trade directly in markets, lifting bans on certain shares, and increasing shareholder thresholds triggering registration obligations.
• Streamlined Approvals: Certain capital increases no longer require Commission approval.
• Banking Activities Support: Support companies may offer services to payment method issuers and operators, subject to justified denials.

Additional Provisions: The law introduces parametric securities, paid upon the occurrence of an event, and mandates companies to offer products matching client profiles.

The Chilean SEC may pass general regulations, while the Chilean Central Bank may enact regulations to standardize cryptocurrency.

La entrada Chilean Fintech Regulation se publicó primero en Brokering Abogados.

This article will analyze the new version of Chilean Technical Norm 2190, NCh2190, issued in 2019, which regulates the ground transport of hazardous goods. In specific, we will compare the new edition of the norm with the one previously in force, issued in 2003, highlighting the changes introduced by this new version.

1.- Introduction

As the title of the norm attests, NCh2190 regulates the security labels with which the dangers of the hazardous goods being transported must be identified. Within this regulation, the different kinds of labels, signs, and tags are defined, including the way of use and the places on which they must adhere.

NCh2190:2003 had a wider scope of coverage. It applied to the import/export, manipulation and storage in transit of hazardous substances, this was eliminated on the new version. Also, it included certain sections dedicated to agricultural pesticides, which was not included in the new version as now there are other specific regulations.

The norm details, with graphics and other content, the shape and contents of the different signage, such as labels, signs, and tags, which must be placed on the surface of the package, the shipping unit, among others, when they contain hazardous substances.

2.- Goods regulated by the norm

The 2003 version of the Norm dictated that it applied to the goods mentioned on NCh2120/1 to /9, in the classes and classifications established therein, that is:

• Class 1: Explosives
• Class 2: Gasses
• Class 3: Liquids
• Class 4: Solids
• Class 5: Oxidants and organic peroxides
• Class 6: Toxic and Infectious substances
• Class 7: Radioactive substances
• Class 8: Corrosive substances
• Class 9: Various substances and dangerous objects

On this older version, there are no specific references to radioactive substances, except for the necessary mentions included on its regulatory annexes.

The present norm uses the same references of the NCh2120 in addition to new categories, which have their labels, signs, and tags assigned.

A few examples of the new substances that are specially regulated are the following:

• Radioactive materials
• Substances hazardous to the environment
• Lithium Batteries
• Substances that are transported at high temperatures

3.- Differences between labels, signs, and tags

The new version of NCh2190 differentiates between labels, signs, and tags, which correspond to the mandatory security signage. The distinction between each one is the following:

• Label: It is a square installed with a vertex facing upwards, placed on the surface of the package, though the location may vary considering the size of the package. They are hazard labels that must be placed on the goods listed on NCh382, which determines the terminology and general classification of hazardous substances.  
• Sign: A square installed with a vertex facing upwards, on transport units and bulk containers, on their external walls
• Tag: It consists of additional information not included on the label or sign. They must be placed on packages. If the items are not packaged, they must be included on the object itself, its support or its handling, storage or commissioning device.

Pictured: An example of the different labeling formats

The prior version of the norm had the same classification but was less detailed in its regulation of each category.

4.- Broadening of the regulations regarding the design of labels, signs, and tags and their references

Regarding the design of the signage, the new nom reorders and expands the regulations of each kind, imposing a series of special rules for certain substances (such as the ones listed on section II, above). Both regulatory and regular Annexes of the norm were simplified, where before there were more than 20, now there are only three: one regulatory annex, which contains the references for the labels and their characteristics, and three informative annexes, one that  shows the reference colors that can be used on the signage, one that presents examples of the utilization of the signage on transport units, and finally one that shows how to place labels.

In addition to the changes in the design of the labels of each class and their classes, another change is the lifting of the obligation to include descriptive words inside the diamond, such as “infectious substance”, “explosive”, among others, except for labels for radioactive and fissionable substances, on which the text remains mandatory. In some cases, the text is optional.

Comparison

The abovementioned implies that it is necessary for the companies that transport hazardous substances to review their signage if they are to conform to the new regulations.

• Marking requirements

The new norm includes a specific section referred to marking (6.2), which expands what was covered. It establishes an obligation to indicate the name of the official transport designation and lists the places on which it must be placed, in addition to the characteristics of the marking. Furthermore, it expands the regulations regarding the UN numbers, changing the substances to which they apply[1], and establishing how they must be included, their sizes, among others.

Example

• Legal force as an official norm

The Institute for National Normalization published the 2019 version of the norm on January 28, 2019. However, it still hasn’t been declared as an official norm, and thus it is not mandatory. Nevertheless, Exempt Resolution No. 1939, published on June 10, 2019, communicated the legal force of this version of the norm for auditors of the Weapons Control Act. This only applies to this specific authority.

For now, the older version of the norm continues to be in force and continues to be official, as was declared by Supreme Decree 43 of the Ministry of Transport, published on June 21, 2004. Furthermore, other norms that cite NCh2190, such as Supreme Decree 298, which regulates the ground transport of hazardous materials, and Supreme Decree 43 of the Ministry of Health, which regulates the storage of hazardous substances, haven’t been updated.

Now, considering that there are regulations that cite NCh2190:2019 have been recently issued, it is likely that in the short term it will be declared an official norm and that the existing regulations that cite it will be updated. Considering the aforementioned, we recommend that the individuals and organizations that transport hazardous substances have this new regulation in mind and that they update their signage and internal processes.

[1] On the prior version of the norm, all substances included in Clause 6 must incorporate their respective UN number. The current version specifically lists which goods must incorporate it (Section 6.2.2.1).

La entrada NCh2190 :2019, regarding ground transport of hazardous goods. se publicó primero en Brokering Abogados.

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

La entrada Regulation of medical devices in Chile se publicó primero en Brokering Abogados.

The procedure for food imports in Chile, involves the fulfillment of two requirements established by the Health Authority of the Metropolitan Region (known as “SEREMI de Salud R.M”):

• Getting a Certificate of Customs Destination (known as “Certificado de Destinación Aduanera”); and,
• Getting the Authorization of Use and Disposition of Imported foods (known as “Autorización de Uso y Disposición de Alimentos Importados”).

Both applications may be approved or denied, depending on whether the imported foods comply or not with the current health regulations.

CERTIFICATE OF CUSTOMS DESTINATION

It is a Resolution issued by the correspondent Health Authority, by which the imported foods entered to the country, and which authorizes the removal and transportation of the products, from the customs facilities to the warehouse or authorized deposit, where the products are going to be stored.

The said certificate (Certificate of Customs Destination) must show the address of the warehouse, duly authorized, the Health Resolution, route, and transportation conditions of the imported products.

ADMINISTRATIVE PROCEDURE FOR FOOD IMPORTS IN CHILE

The Certificate of Customs Destination (CCD) must be requested at the correspondent Regional Ministerial Secretariat of Health (SEREMI) of the customs office by which the products were entered, through the form created for that purpose.

As for the SEREMI of the Metropolitan Region, there are two ways to carry out this kind of procedures:

• AS DIGITAL
• Going to the Customer Service Offices

Whatever the way you choose to obtain the CCD in the Metropolitan Region, the following documents are going to be requested by the Health Authority:

• Invoice of the product
• Copy of the Health Resolution of the authorized warehouse of destination
• Air waybill

As digital

In order to access to the Digital System of the Health Authority, you must go to the following address: AUTORIDAD SANITARIA DIGITAL

Once there, you should register, access with your password and select the option “Comercio Exterior” and then “Certificado de Destinación Aduanera”.

FFill all the information requested in the “Solicitud de Certificado de Destinación Aduanera” which is the option “Comercio Exterior” and select the CCD type for foods. After having filled all the data requested in the application, the system will deliver a receipt to make the payment.

Going to the Customer Service Offices

In order to obtain the CCD, you must concur to one of the following offices, from Monday to Thursday 9:00 to 13:30 hrs. and Fridays from 9:00 to 13:00 hrs.:

• Central Office: Avenida Bulnes # 194, Santiago.
• Office in Melipilla: Plaza de Armas # 550, Melipilla
• Office in Talagante: Esmeralda # 1177, Talagante
• Office in San Bernardo: Freire # 493, San Bernardo
• Office in Chacabuco: Av. General San Martín # 243 – 253, Colina
• Oficina in Cordillera Concha y Toro # 469, Puente Alto

In these offices you should request and complete the form of “Solicitud de Certificado de Destinación Aduanera” (CCD) corresponding to the product to import and pay the correspondent fee.

INFORMATION TO CONSIDER FOR FOOD IMPORTS

In case that the application does not comply with the requirements or if the product cannot be imported to the country, the issuance of the CCD will be denied through founded decision, issued within the third day counted from the date of the application.

The CCD (Certificate of Customs Destination) must be granted, within the terms established by the Law number 18.164/82 of the Ministry of Finance or the one which replaces it.

“This Certificate (CCD) does not allow to its holder to move to any place other than the destination warehouse, change, use or consume the foods signaled in them”.

Once the process of the CCD and the products having been retired from the primary locations of Customs, the importer will assume the following obligations and responsibilities:

• Move the food products to the warehouse indicated in the CCD, through the route and transport conditions indicated in the same Certificate.According to article number 68 of the Food Health Regulation (D.S. 977/96), the vehicles transporting perishable foods, which require cold for its conservation, must have the Health Authorization for that purpose.
• Maintain the products in the said warehouse, not being allowed to use them, consume them, sell them, transfer them or dispose of them at any title, before obtaining the Authorization of Use and Destination, issued by the Health Authority of the Region in which the destination warehouse is located.
• Request the Authorization of Use and Destination from the Health Authority of the Region in which the warehouse of destiny is located, attaching a copy of the CCD with the application.

The non-compliance of the conditions mentioned before will be sanctioned by the Health Authority, prior instruction of the correspondent sanitary investigation, according to the established in book X (ten) of the Health Code (D.F.L. 725/67).

AUTHORIZATION OF USE AND DISPOSITION OF FOOD IMPORTS

Consists on a Resolution issued by the Health Authority (Seremi de Salud – Regional Ministerial Secretariat of Health), correspondent to the jurisdiction in which the warehouse, which the products are stored, is located. This resolution allows or forbids the importer to use, sell, consume, transfer and dispose of the imported products. Before the approval, the Health Authority (Seremi de Salud R.M.) will inspect and/or run lab tests on the products in order to check whether the products comply with the Chilean legislation or not.

ADMINISTRATIVE PROCEDURE

In the Regional Ministerial Secretariat of Health of the Metropolitan Region (Seremi de Salud R.M.) are two ways to carry out this kind of procedures:

• AS DIGITAL
• Going to the Customer Service Offices

Whatever the way you choose to obtain the Authorization of Use and Disposition of Imported Food Products, the Health Authority of the Region will ask for the following documents:

• Certificate of Customs Destination
• Copy of the Purchase Invoice
• Copy of the Health Resolution of the Warehouse or authorized deposit
• Health Certificate from the country of origin of the product, valid for each import license or free product sales certificate.
• Label or label project with the format that allows complying the established in the Food Health Regulation (D.S. 977/96)

Notwithstanding to the above, the Health Authority is entitled to request more details about a product.

As digital

To access the Digital System of the Health Authority, you should connect to the Internet through the Google Chrome web browser, and go to the following address: http//asdigital.minsal.cl/asdigital/

Once inside the website, you must sign in, enter your password and select the option “Comercio Exterior” and then “Autorización de Uso y Disposición”.

Fill the information of the Authorization of Use and Disposition application (Solicitud de Autorización de Uso y Disposición) which is the option “Comercio Exterior” and attach all the documents to the use and disposition application.

After the application has been filled, the System will issue a receipt to make the payment.

GOING TO THE CUSTOMER SERVICE OFFICES

To carry out the application for the Authorization of Use and Disposition of imported food products, you must concur to the following office, Mondays to Tuesdays from 09:00 to 13:30 hrs and Fridays from 09:00 to 13:00 hrs.

Central Office: Avenida Bulnes #194, Santiago: at this office you must request and fill the application form for the Authorization of Use and Disposition of imported food products, paying the correspondent fee.

INFORMATION TO CONSIDER

The products that are announced as foods, and which possess or attributes themselves therapeutic properties, must have the determination of the Applicable Control Regime, issued by the Chilean Public Health Institute (ISP), according to the established in article 70 of the Supreme Decree number 1.876/95.

The Authorization Resolution is granted to the applicant after the products have been verified and its compliance or non-compliance with the national legislation has been established.

TECHNICAL PROCEDURES FOR FOOD IMPORTS

The process to follow is determined considering the epidemiological risk, food composition, history of previous imports and complaints about imported foods (or infractions), and which may be: direct without inspection, inspection without sampling, and inspection sampling.

DIRECT PROCESS (WITHOUT INSPECTION)

Once the importer has informed the arrival of the products to the country, and after the documents from the imported products had been analyzed, the Health Authority from the jurisdiction in which the warehouse of destiny is located, issues the Authorization Resolution, without inspecting the product.

INSPECTION WITHOUT SAMPLING

In this case, the products are inspected in its storage location in order to check and record, at least, the following:

• Identification of the product, including the CCD
• Physical characteristics at the moment of the inspection
• Labeling
• Stowage conditions
• Inspection the temperature and measurement records of the product, if necessary. According to the outcome of the inspection carried out by the Health Authority, the same is entitled to proceed to take samples and run a test on them later on.

INSPECTION SAMPLING FOR FOOD IMPORTS

The same process described on the last point. The only difference is that, in this procedure, samples of the products are taken in order to be analyzed according to the parameters established for the type of food in question. The samples shall be taken by qualified technical personnel from the Health Authority of the Metropolitan Region and shall be analyzed in the laboratories of Environment Health or another analysis laboratory recognized by the Health Authority.

When the jurisdiction where the destiny warehouse is located in the Metropolitan Region, the costs generated from the sampling and its corresponding analysis, must be paid at the Customer Service Office of the Health Authority of the Metropolitan Region, 72 hours after the samples were taken. Also, in order to speed up the process, it is suggested to make reference to the number in it at the moment of the payment.

It is required to present all the documentation left by the professional of the Health Authority in the inspection.

REJECTION OF THE FOOD INTERNMENT APPLICATION

If once all the procedures described above have been applied, it is found that the product does not comply with the current Chilean legislation, the Health Authority issues a Rejection Resolution. In this Resolution the causes of the rejection are detailed, and the product, factory of origin and elaboration codes of the product are identified. Also, the Authority gives the importer a term of 5 days (working days) counted from the date of the issuance, in order to inform the destiny of the products, which may be:

• Re-exportation
• Destruction
• Another use (authorization from the competent Authority needed)

The interested can request, in writing, a reconsideration of the decision adopted, except in those food imports to which the article 105 of the Food Health Regulation (D.S. 977/96) has been applied. In case that this request is accepted, the analysis of the product is carried out considering the double amount of samples used initially.

The denaturation and destruction of the rejected foods are requested to the Health Authority and is carried out under the oversight of the same. The costs derived are charged to the importer.

In the case that the importer decides to destroy or remove the rejected product on his own, it must be reported to the Health Authority, in writing, within the term stipulated for it and attaching all the documents required.

RE-ENTRY OF FOODS

Foods which are re-entered to the country, whatever the rejection cause in the country of destiny might be, must comply with the established in the procedures of Certificate of Customs Destination (CCD) and Authorization of Use and Disposition of imported products, informing the cause of the rejection through a certificate issued by the competent authority or a commercial technical document.

The total of the imports, corresponding to re-entered foods, shall undergo the correspondent inspection sampling.

La entrada Procedure for food imports in Chile se publicó primero en Brokering Abogados.

REGISTRATION OR MATRICULATION OF THE AIRCRAFT AND ITS NATIONALITY

Registration or matriculation

Art. 32. The registration or matriculation of the aircraft, aircraft registration, in the National Record of Aircraft gives the aircraft the Chilean nationality.

To the owner of the aircraft a matriculation certificate shall be given, which shall prove the nationality of the aircraft and its classification.

Art. 33. The aircraft registered in the National Record of Aircraft shall have distinctive marks of their Chilean nationality and their matriculation. This marks shall be worn on the outside of the aircraft in order to simplify its identification.

Art. 34. There shall be only one matriculation for each aircraft.

Art. 35. The aircraft shall have the nationality of their registration. An aircraft registered in the National Record of Aircrafts looses the Chilean nationality when it’s being registered in a foreign country.

If a foreign country does not have a registration system for military aircraft and other aircraft owned by the foreign State is to be supposed that the aircraft have the nationality of the country they serve.

Art.36. In order to register an aircraft matriculated in a foreign country, the cancellation of the previous matriculation shall be proven first.

Art. 37 No aircraft shall take flight over Chilean air space without being properly registered in Chile or in another country, or if it is registered in more than one State at the same time or if it does not wear its nationality and matriculation marks.

Notwithstanding, the aircraft lighter than 170 kilograms, shall be called “ultralight vehicles” and shall be flown in accordance with the conditions set forth by the aeronautical authority and shall be exempt from registration. 

The aircrafts that can be registered in the National Record of Aircrafts.

Art. 38. The following aircrafts may be registered in Chile

• The ones owned by Chilean individuals;
• The ones owned by Chilean legal entities, that is those established in accordance with the Chilean law and having its real and effective principal place of business in the country and that the majority of its directors or administrators, as it may apply, are Chilean and that the majority of its capital belongs to Chilean individuals or legal entities, and
• The ones owned by communities, as long as the majority of it is owned by Chilean individuals and legal entities that comply with the conditions set forth in.

Nevertheless, the aeronautical authority shall be allowed to register aircraft owned by individuals or legal entities, as long they perform a permanent activity or profession in the country. The same authorization can be given to foreign aircraft, operated, in lawful possession, by Chilean aeronautical companies.

Art. 39. In Chile foreign aircraft shall be registered when they have been given accordingly to an agreement in which the owner holds its legal title until a specific duty has been performed or until the total payment of the price, as long as the holder in due course applies to one of the conditions set forth in the previous clause.

As long the document acknowledging the fulfillment of the condition, the payment of the total purchase price or the express relinquish, the title of the aircraft over or a mortgage shall not be conveyed without the owner authorization.

Art. 40. The foreign aircraft or the aircraft build or assemble in Chile can have a provisional register in the National Record of Aircraft, at the owner’s request, in accordance with the terms set forth in article 38, to the sole purpose of doing test flights and training at the place where it was built or acquired, to its transfer to a determined place in the national territory or in those cases the aeronautical authority may find adequate.

This registration shall be given only to a maximum term of four months, that may be renewed only once for the same amount of time.

Art. 41. The aircraft owned by an international organization to which is a party of, may be registered in Chile in accordance with an agreement by and between this international organization and the Chilean State, as long as it shall not use for commercial purposes.

Aircraft registration cancellation

Art. 42 The Keeper of the National Record of Aircraft shall cancel the registration, at his own initiative or at party request, in the following cases:

• When the aircraft was registered in another country.
• When the owner no longer complies with the conditions set forth in the article.
• When the Keepers receives a copy of the aeronautical authority declaring the loss, destruction, uselessness or dismount of an aircraft
• When the airworthiness certificate has not been renewed for five consecutive periods.
• When the temporal registration of article 40 has expired: and
• in the other cases named by law.

Art. 43 The register shall not be canceled when the aircraft is mortgaged or there are privileged credits registered, without previous cancellation of such lien, unless the debtor agrees to.

Nevertheless, in the case set forth in article 43 c), the cancellation shall be done, even though there may be mortgages or privileged credits registered, after 5 years of the resolutions acknowledging the loss, destruction or uselessness of the aircraft.

La entrada Aircrafts’ registration in the Chilean Aeronautical Code se publicó primero en Brokering Abogados.

Pesticides registration for the household

Pesticides for the household or for sanitary use are those used to combat vectors and pests in the households, inside or outside the houses, building, industries and their industrial processes, warehouses, educational institutions, commercial premises, parks, gardens, and for ships or airplanes, as well as repellents or attractants not applied directly to human or animal skin and those contained in commercial products such as paints, varnishes, hygiene products, and others.

Before a pesticide can be commercialized in Chile, it has to undergo a lab analysis first. For this purpose, a foreigner can either create a new company or appoint someone here in Chile that will ask for the registration under his name and afterward transfers the registration to the foreign company, when it establishes a brand here in Chile.

The documentation that has to be provided is as follows:

• Formula (quantitative and qualitative)
• Monograph (including the active substance); physical and chemical characteristics, compatibility, toxicological properties; disinfecting action; application field; antidotes
• Any technical data might be considered as necessary for further information about the product.
• If it is an imported product, attach the authorization of the product for the purposes it is required in Chile from its original country, whether it be elaborated (ready for its commercialization) or the active matter, granted by the competent authority and properly registered with the official notary public in that country.
• Label format, which must include the formula of the product, preventive and sanitary recommendations for its usage, usage instructions (dose, frequency, etc.) and identification of the company.
• Two samples of the product, description of the container in which it will be sold.

Analysis methods.

The lab testing will cost depending on the active ingredients up to U$2,000.- Once the records have been checked and the report of the Public Health Institute has been received, the technical report will be processed and result in the corresponding authorization, through a decision of the Director of the respective Health Service. This will be a valid decision in the whole country, so the Service that elaborates it will have to send a copy of it to the rest of the Health Services of the country and the central ministerial level.

The duration of the whole procedure lasts about 1 year.

Pesticide’s registration to be used in the fields (agrochemicals).

Pesticide to be used in agriculture are called in Spanish plaguicida. And plaguicidas are chemicals, organic or inorganic, or natural substance that is used to combat weeds, diseases or pests potentially, capable of causing damage to organisms or objects. This includes the formulated product and the active substances with which it is formulated, with insecticidal skills, growth regulators from insects, suffocating agents, acaricides, nematicides, molluscicides, rodenticides, lagomorphic, fumigants, fungicides, bactericides, disinfectants, viricides, microbicides, wood preservatives, algaecides, herbicides, defoliants, desiccants, Phyto regulators, adjuvants, antiperspirants, attractants, pheromones, allelochemicals, repellents, crop protection coatings, inductors resistance and others that are used in agricultural and forestry activities.

Pesticides to be used in the fields or crops must be registered by SAG. Usually, foreign companies that want to market those products in Chile seek for a Chilean partner since SAG requires for the registration of such products that each company that wants to register agrochemicals have its own Technical Director that can be contacted directly by SAG. This Technical Director cannot work for more than one company in this area. Rule 1557/2014 establishes 3 ways to apply for registration: identity (mostly molecule-based), equivalence and special authorizations for research purposes. The most used way is identity. Up today no registration based on equivalence has been made and there is no clear date when SAG will allow registering based on equivalence because they are waiting to have enough registration to make this procedure feasible.

Agriculture associations can inform authorities through a regulated procedure the kind of pesticides they would like to obtain a fast track approval to target their needs in that matter. Authorities will take special account of those pesticides that can address farmers’ concerns. Therefore, we suggest companies trying to introduce new products in the Chilean market to contact those associations.

La entrada Pesticide’s registration in Chile se publicó primero en Brokering Abogados.