Chile ISP Medical Device Registration Guide: Classification, Process & 2026 Decree Changes

Chile's Medical Device Regulatory Landscape

Chile is one of Latin America's most stable and prosperous markets, with a sophisticated healthcare system and growing demand for advanced medical technologies. The country's medical device market is valued at approximately $1.2 billion and continues to expand as both public and private healthcare sectors invest in modernizing clinical infrastructure.

Medical device regulation in Chile is overseen by the ISP (Instituto de Salud Pública de Chile) — the Public Health Institute. ISP is the national regulatory authority responsible for ensuring the quality, safety, and efficacy of medical devices, pharmaceuticals, and other health products marketed in Chile.

Chile's regulatory framework is currently undergoing a significant transformation. Historically, only a narrow range of devices required mandatory registration. But with the publication of Exempt Decree No. 25 in March 2026, Chile is transitioning to a broader mandatory registration system that will affect dozens of additional device categories over the next two to three years.

This guide covers everything you need to know about registering medical devices in Chile: the classification system, registration process, documentation requirements, fees, timelines, and what the new decree means for your market entry strategy.

The Regulatory Authority: ISP

The Instituto de Salud Pública de Chile (ISP) operates under the Ministry of Health (MINSAL) and is responsible for:

• Sanitary registration of medical devices and IVDs
• Conformity assessment and verification
• Post-market surveillance and technovigilance
• Import control through the GICONA electronic platform
• Authorization of medical device storage warehouses

ISP was formerly known as ANAMED (Agencia Nacional de Medicamentos), and some older references still use that acronym. The current official designation is ISP.

The primary regulations governing medical devices in Chile are:

• Reglamento de control de productos y elementos de uso médico — the core regulation for medical device control
• Exempt Decree No. 25 (March 2026) — expands mandatory sanitary control to 39 additional device categories
• Health Code (Código Sanitario), Article 111 — establishes the legal basis for health product regulation

Device Classification in Chile

Chile uses a four-class risk-based classification system aligned with international IMDRF principles:

Class	Risk Level	Examples
Class I	Low risk	Bandages, surgical tape, manual wheelchairs, non-invasive wound care products
Class II	Moderate risk	Condoms, hypodermic needles, syringes, contact lenses, dental cements
Class III	High risk	Orthopedic implants, pacemakers, ventilators, surgical lasers
Class IV	Critical risk	Heart valves, stents, implantable defibrillators, IVD reagents for blood screening

Classification is determined based on the intended use, duration of body contact, invasiveness, and the potential consequences of device failure. The rules follow the Global Harmonization Task Force (GHTF) guidance and are broadly similar to the EU MDR and FDA classification frameworks.

What Changed: Exempt Decree No. 25 (March 2026)

The Old System

Before March 2026, Chile required mandatory sanitary registration for only a narrow set of devices:

• Contraceptives
• Medical gloves
• Hypodermic needles
• Syringes

All other medical devices could be marketed without formal registration, though a voluntary Certification of Background Review (Certificación de Antecedentes) was available through ISP.

The New Decree

On March 6, 2026, the Chilean Ministry of Health published Exempt Decree No. 25, which incorporates 39 additional categories of medical devices and IVDs into the mandatory sanitary control regime under Article 111 of the Health Code.

The 39 newly regulated device categories primarily cover:

• Diagnostic equipment — imaging systems, patient monitors, electrocardiographs
• Treatment equipment — electrosurgical units, infusion pumps, anesthesia machines
• Clinical monitoring equipment — pulse oximeters, capnographs, fetal monitors
• Medical software — clinical decision support software, AI-based diagnostic tools
• Critical hospital equipment — sterilization equipment (steam and EtO), ventilators, defibrillators

These devices are classified as medium- and high-risk technologies, many of which are critical for patient diagnosis, treatment, and monitoring.

Implementation Timeline

The decree establishes a phased implementation:

Milestone	Timeline
Decree published	March 6, 2026
ISP must issue technical guidelines	Within 12 months of publication
Conformity verification required (first group)	24 months after publication
Conformity verification required (second group)	36 months after publication

Manufacturers and importers can voluntarily initiate the conformity assessment process before the mandatory deadlines, once ISP issues the corresponding technical guidelines.

What This Means for You

If you market or plan to market devices in Chile that fall within the 39 newly regulated categories, you should:

1. Begin preparing documentation now — compile technical files, safety data, and compliance certifications
2. Apply for Certification of Background Review — this voluntary procedure provides a head start on the mandatory process and demonstrates proactive compliance
3. Monitor ISP guidance publications — ISP must issue technical standards within 12 months, which will define exact conformity assessment requirements
4. Appoint a local representative — if you do not have a Chilean legal entity, you need an in-country representative

Registration Process: Step by Step

Step 1: Appoint a Local Representative

Foreign manufacturers without a legal entity in Chile must appoint a Chilean legal representative who will:

• Hold the sanitary registration
• Interface with ISP on regulatory matters
• Manage import documentation and post-market obligations

Selecting the right representative is critical because the registration holder controls the market authorization. If you switch representatives later, you must transfer the registration.

Step 2: Company Registration

Before submitting device applications, the company (or its local representative) must register with ISP as a healthcare-related entity. This includes:

• Registering in the GICONA system
• Registering an authorized storage warehouse in Chile
• Obtaining system credentials and passwords

Step 3: Device Classification

Determine the correct risk classification (Class I–IV) for your device. Classification affects the documentation requirements, review depth, and timeline. Misclassification can lead to delays or rejection.

Step 4: Prepare Documentation

The documentation package varies by classification but generally includes:

Document	Class I	Class II	Class III	Class IV
Application form	Required	Required	Required	Required
Free Sale Certificate (FSC/CFS)	Required	Required	Required	Required
Technical report	Required	Required	Required	Required
Manufacturer's quality certification (ISO 13485/GMP)	Recommended	Required	Required	Required
Declaration of conformity	Required	Required	Required	Required
Risk analysis	—	Recommended	Required	Required
Clinical data	—	—	Required	Required
Labeling and IFU in Spanish	Required	Required	Required	Required
Conformity verification evidence	—	—	Required	Required

Step 5: Submit via GICONA

Chile uses the GICONA electronic platform for device registration. The process is:

1. Access the GICONA system and select "Request Registration"
2. Complete the application form
3. Attach all required documents
4. Select payment method:
   • Online through the Treasury of the Republic (TGR) website
   • Deferred payment at ISP
5. A purchase order is generated — save the order and pay via TGR or print the payment form

Step 6: ISP Review and Approval

ISP reviews the submission. Processing times are:

Classification	Official Timeline
Class I	60–75 days
Class II	6 months
Class III	6–10 months
Class IV	12+ months

In approximately 60 days for Class I devices, ISP sends a notification via email indicating whether the application has been approved or if additional information is needed.

Step 7: Registration Granted

Once approved, the sanitary registration is issued. Registration in Chile does not expire — it remains valid indefinitely unless:

• The device's Free Sale Certificate expires
• A significant modification in design, manufacturing, or intended use occurs (requiring new registration)
• ISP revokes the registration for safety or compliance reasons

Registration Fees

ISP publishes its fee schedule in the Catálogo de Prestaciones. Key fees (in Chilean Pesos, CLP):

Service	Fee (CLP)	Approximate USD
Sanitary registration of medical devices	$182,232	~$200
Sanitary registration of IVDs	$536,789	~$580
Verification of conformity	$3,223,485	~$3,500
Company registration with device list	$343,205	~$370
Background review for medical devices	$536,789	~$580
Authorization of storage warehouse	$1,002,956	~$1,080
IVD registration with ISP verification	$6,355,636	~$6,850
Modification/update of registration	$66,977	~$72

Fees are subject to change. Verify current rates directly with ISP before applying.

Importing Medical Devices into Chile

Devices WITH Sanitary Registration

Devices that hold a valid sanitary registration can be imported through standard customs procedures. The importer must present the registration certificate and comply with standard import documentation.

Devices WITHOUT Sanitary Registration

For devices that do not yet require mandatory registration (i.e., not on the list of four traditional categories or the 39 new categories), importers must obtain a Customs Destination Certificate (CDA) through ISP's GICONA 2.0 platform. The CDA is the regulatory mechanism that allows non-registered medical devices to enter Chile.

The CDA process requires:

• Registration in the GICONA 2.0 system
• Identification as a company or natural person
• Registration of a warehouse for device storage
• Payment of the official CDA fee

Temporary Import for Exhibitions

Medical devices imported temporarily for conferences, trade shows, or exhibitions also require a CDA through GICONA 2.0. This allows non-registered devices to enter Chile for demonstration purposes for a limited period.

Quality System Requirements

Chile does not mandate ISO 13485 certification for all device classes, but it is strongly recommended and effectively required for Class III and IV devices. The conformity assessment process under the new decree requires evidence of compliance with applicable technical standards, including NCh (Chilean standards) and ISO standards.

Key quality system expectations:

• ISO 13485 certification is the most widely accepted evidence of QMS compliance
• ISO 9001 / GMP certification may be accepted as a minimum for lower-risk devices
• Good Manufacturing Practice documentation is required as part of the registration dossier
• Higher-risk devices face more stringent quality system scrutiny

Labeling Requirements

All medical devices marketed in Chile must have:

• Labeling in Spanish — all product labels, instructions for use, and descriptions must be in Spanish
• Manufacturer name and address
• Device description and intended use
• Storage conditions
• Expiration date (where applicable)
• Lot or serial number
• Country of manufacture
• Any required warnings or precautions

Post-Market Obligations

Chile's technovigilance system requires:

• Adverse event reporting — significant adverse events must be reported to ISP
• Field safety corrective actions — recalls and safety alerts must be communicated to ISP and affected users
• Periodic safety updates — may be required for higher-risk devices
• Complaint handling — manufacturers must maintain complaint records and trend analysis

Under the new decree, technovigilance requirements will extend to the 39 newly regulated device categories as they come under mandatory control.

Advantages of the Chilean Market

Chile offers several advantages for medical device manufacturers:

• Indefinite registration validity — unlike most countries requiring 5-year renewals, Chilean registrations do not expire
• Fastest LATAM approval for Class I — 60–75 days is among the fastest in the region
• Under U.S.-Chile FTA — U.S.-origin medical devices enter Chile duty-free
• Stable regulatory environment — Chile is an IMDRF observer with a well-functioning healthcare system
• Reliance on international approvals — ISP accepts CFS/CFS from major markets (FDA, CE, Health Canada, TGA, PMDA), which can streamline the process
• Regulatory reliance framework — since January 2026, ISP can rely on inspection findings from trusted international authorities for GMP assessments

Chile vs. Other LATAM Markets

Factor	Chile (ISP)	Brazil (ANVISA)	Mexico (COFEPRIS)	Colombia (INVIMA)
Classification	Class I–IV	Class I–IV	Class I–III	Class I–IV
Timeline (Class II)	6 months	6–12 months	3–6 months	4–8 months
Registration validity	Indefinite	10 years	5 years	10 years
Local representative	Required	Required (BRH)	Required	Required
Language	Spanish	Portuguese	Spanish	Spanish
ISO 13485 required	Recommended	Required (BGMP)	Recommended	Required
Fast-track pathway	Not available	Not available	30 days (FDA/CE)	Automatic (Class I/IIa)

Common Mistakes to Avoid

1. Assuming registration is not required — The new decree significantly expands mandatory registration. Check whether your device falls within the 39 newly regulated categories.

2. Not preparing for the phase-in deadlines — The 24- and 36-month implementation windows will arrive faster than expected, especially given that ISP must first issue technical guidelines.

3. Appointing the wrong local representative — Your registration holder controls your market authorization. Choose a representative you trust and negotiate clear terms for potential transitions.

4. Submitting incomplete documentation — ISP rejects applications with missing documents. Ensure your technical file, FSC, quality certifications, and Spanish labeling are all complete before submission.

5. Ignoring the voluntary Certification of Background Review — This optional process provides a head start on compliance and demonstrates good faith to ISP before the mandatory deadlines arrive.

6. Not monitoring ISP technical guidelines — ISP has 12 months from the decree's publication to issue technical standards. These will define exact conformity assessment requirements for each device category.

Practical Checklist for Chile Market Entry

• Determine if your device falls within mandatory registration (traditional 4 categories or 39 new categories)
• Classify your device (Class I–IV)
• Appoint a Chilean legal representative
• Register your company in GICONA
• Compile technical documentation (FSC, quality certificates, technical report)
• Translate labeling and IFU into Spanish
• Submit application via GICONA
• Pay registration fees via TGR
• Respond to any ISP queries during review
• Obtain sanitary registration
• Establish import procedures (CDA for non-registered devices, standard for registered)
• Set up technovigilance procedures for post-market compliance

Key 2026 Regulatory Updates

Date	Update	Impact
March 6, 2026	Exempt Decree No. 25 published	39 device categories brought under mandatory sanitary control
January 28, 2026	Regulatory reliance framework effective	ISP can rely on GMP inspections from trusted international authorities
March 5, 2026	ISP launches public consultation on classification guidelines	Proposed guidelines for product classification under sanitary control
2026–2027	ISP issues technical guidelines for new categories	Exact conformity assessment requirements defined (within 12 months of decree)
2028	Conformity verification required for first group	24-month deadline for first batch of newly regulated devices
2029	Conformity verification required for second group	36-month deadline for remaining newly regulated devices

Frequently Asked Questions

Does Chile require ISO 13485 certification?

ISO 13485 is not legally mandated for all classes, but it is strongly recommended and effectively expected for Class III and IV devices. ISP accepts quality management system certificates from recognized certification bodies.

Can I market my device in Chile without registration?

If your device is not in the four traditional categories (contraceptives, gloves, needles, syringes) or the 39 newly regulated categories, you can currently import it using a Customs Destination Certificate (CDA). However, the regulatory landscape is shifting toward broader mandatory registration, so this window is closing.

How long does registration take?

Class I devices typically take 60–75 days. Class II devices take approximately 6 months. Class III and IV devices take 6–12+ months. These are official timelines — actual timelines may vary depending on ISP workload and application completeness.

Does registration expire?

No. Chilean sanitary registrations do not expire. However, registration is linked to the validity of the device's Free Sale Certificate. If the FSC expires and is not renewed, the registration may be affected.

Do I need a local representative?

Yes. Foreign manufacturers without a Chilean legal entity must appoint a local legal representative who will hold the registration and serve as the liaison with ISP.

What language must documentation be in?

All labeling, instructions for use, and product descriptions must be in Spanish. Technical documentation may be submitted in English with Spanish summaries, but ISP's preference is for Spanish-language submissions.

Will the new decree affect devices already on the market?

Yes. Devices in the 39 newly regulated categories that are already marketed in Chile will need to obtain conformity verification within the 24- or 36-month implementation period. Manufacturers should begin the compliance process early to avoid market disruption.