一.Chilean Medical Device Regulatory Authority
The primary regulatory body for medical devices in Chile is the Instituto de Salud Pública de Chile (ISP), which is part of the Ministry of Health (Ministerio de Salud, MINSAL). The department within the ISP responsible for medical devices is the Agencia Nacional de Dispositivos Médicos, Innovación y Desarrollo (ANDID / ANDIM).
Regulatory Authority Website: https://www.ispch.gob.cl/normativa-andim/
Database link: https://registrosanitario.ispch.gob.cl/
Regulatory Framework
Decree No. 825/1998
二.Risk Classification
Class I: Low risk (e.g., bandages, non-invasive electrodes, examination gloves, reusable surgical instruments, wheelchairs, etc., which come into contact only with intact skin).
Class II: Low-to-medium risk (e.g., short-term invasive catheters, ECG devices, blood pressure monitors, diagnostic ultrasound equipment, etc.).
Class III: Medium-to-high risk (e.g., infusion pumps, certain dressings, defibrillators, condoms, hemodialysis equipment, etc.).
Class IV: High risk (e.g., implants, cardiac stents, pacemakers, devices that come into contact with the central nervous system/circulatory system, etc.).
三.Requirements for Market Authorization
Chile currently has 10 categories of medical devices subject to mandatory registration (DM / DMDIV):
- Single-use latex surgical gloves (disposable latex surgical gloves)
- Latex gloves for medical examination (latex medical examination gloves / diagnostic gloves)
- Condoms – Latex rubber condoms (latex rubber male condoms)
- Sterile single-use hypodermic needles (single-use sterile hypodermic needles)
- Sterile single-use hypodermic syringes (Disposable sterile hypodermic syringes)
- Condoms – Synthetic male condoms (Male condoms made of synthetic materials, non-latex)
- Condoms – Female condoms (Female condoms)
- Portable Automated External Defibrillators (AED)
- Immunohematological Reagents (certain immunohematological reagents / DMDIV)
- HIV Self-Test Kits / Autotests de VIH (and other specific DMDIV)
Most other medical devices: Currently not subject to mandatory registration, but voluntary review (“Revisión de Antecedentes”) is recommended.
四.Authorized Representative
Local Authorized Representative (Representante Autorizado), who must be a natural person or legal entity legally established in Chile.
五.Registration Language
Technical documentation, labeling (rótulo), and Instructions for Use (IFU): Must be submitted in Spanish (Castellano).
六.Registration Process, Timeline, and Official Fees
- Registration Process
（1）Complete preliminary registration for the company/warehouse.
（2）Determine product classification and prepare technical documentation.
（3）Submit the application through GICONA (some products require on-site submission).
（4）Pay official fees (via the TGR Treasury System).
（5）ISP review (administrative + technical).
（6）After approval, indicate the ISP registration number on the label.
- Official Review Timeline
Voluntary Review (Revisión de Antecedentes):
Typical timeline: Usually 2–4 months (most common scenario)
Class I devices: Review period approximately 30–60 days
Class II devices: Review period approximately 60–120 days
Class III/IV Devices: Review period approximately 90–180 days
Certificate Issued: Yes, a “Certificate of Background Review (Certificado de Revisión de Antecedentes)” is issued.
Mandatory Registration (Registro Sanitario):
Typical Duration: Officially set at 60 working days; actual processing time is typically 3–6 months
Class I Devices: Registration period approximately 30–45 days
Class II Devices: Registration period approximately 60–150 days
Class III/IV Devices: Registration period approximately 120–180 days
Certificate Issued: Yes, a "Health Registration Certificate (Registro...)" is issued.
