智利 2026 医疗器械强制注册法令落地！39 大类产品纳入管控 - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Home > News Center > Chile’s 2026 Mandatory Medical Device Registration Regulation Takes Effect! 39 Product Categories Brought Under Regulation

Chile’s 2026 Mandatory Medical Device Registration Regulation Takes Effect! 39 Product Categories Brought Under Regulation

Time：2026-07-14 10:42:56

On March 19, 2026, Chile’s Official Gazette formally issued Exempt Decree No. 25, broadly expanding the scope of mandatory sanitary controls for medical devices and in vitro diagnostic products (IVD). Multiple categories of high-risk equipment are incorporated into the mandatory registration system administered by ISP (Instituto de Salud Pública de Chile).

原

文

链

接

智利强制注册清单-2026年.pdf

一、Core Regulatory Background

（一）Legal Basis

This decree is enacted pursuant to Article 111 of the Sanitary Code and the 1998 Supreme Decree No. 825 regulating medical devices. New product categories are included in the national mandatory sanitary control regime. All domestic manufacturers, importers and distributors must complete compliance verification.

（二）Regulatory Logic: Risk-Based Classification Oversight

Chile adopts differentiated supervision aligned with WHO guiding principles:

Medical Devices: Class IV (Extremely High Risk) > Class III (High Risk) > Class II (Medium Risk)
In Vitro Diagnostics (IVD): Priority oversight for Class C/D high-risk products. Four core screening criteria apply to regulated products:
1. Criticality for clinical use
2. Risk classification (priority for Class II/III medical devices, Class C/D IVDs)
3. Equipment supporting national public health programmes
4. Products frequently reported via adverse event surveillance systems

（三）Competent Authority: Instituto de Salud Pública (ISP), Chile

ISP is the sole national authority responsible for registration certification, review, market surveillance and adverse event alerts. At present, Chile does not officially recognise third-party compliance audit bodies; all conformity assessments are processed directly by ISP.

二、Full List of Products Subject to Mandatory Registration

（一）In Vitro Diagnostics (IVD / DMDIV)

Helicobacter pylori detection kits; HPV human papillomavirus detection kits; respiratory virus detection (Influenza A/B, RSV, parainfluenza, adenovirus, COVID-19, metapneumovirus); complete blood glucose monitoring systems (glucose meters, test strips, lancets, control solutions); early pregnancy & tumour marker detection reagents (Risk Class C/B).

（二）Class IV Extremely High-Risk Implantable Devices (24-month transition period)

Cardiac Implants: Implantable defibrillators, cardiac pacemakers, cardiac resynchronisation devices, coronary stents, cardiovascular catheters, heart valves

Orthopaedic Implants: Hip prostheses and accessories, cochlear implants, breast tissue expanders, implantable surgical meshes, copper intrauterine devices, hyaluronic acid dermal fillers

Infusion Equipment: Insulin infusion pumps and matching consumables

Blood Products: Blood bags (Class III / IV)

（三）Class III High-Risk Diagnostic & Therapeutic Equipment (36-month transition period)

Emergency Devices: Manual defibrillator monitors

Radiology & Radiotherapy: X-ray equipment, brachytherapy devices, external beam radiotherapy linear accelerators, mammography systems, CT, PET/SPECT nuclear medicine equipment

Dialysis Equipment: Haemodialysis concentrates, dialysis machines, dialysis catheters, dialysis filters, intraocular lenses

Life Support: Fixed/transport ventilators, extracorporeal circulation equipment, high-frequency electrosurgical units

Medical Software (SaMD): Tumour imaging planning and analysis software

（四）Class II Medium-Risk Equipment (36-month transition period)

Automatic sphygmomanometers, CPAP/BPAP non-invasive ventilators, steam / ethylene oxide sterilisation equipment.

三、Core Mandatory Compliance Requirements

（一）Market Access Threshold: ISP Sanitary Registration Certificate Mandatory

Upon expiry of transition periods, products on the list without valid sanitary registration certificates cannot be manufactured, imported, distributed or sold. Applications can be submitted by single product, product family, series or complete system to reduce declaration costs for multiple models.

（二） Mandatory Compliance with Full Set of International Standards

Conformity verification for all products requires compliance evidence against the following standards:

General Horizontal Standards (Applicable to all categories)

NCh ISO 14142-1/2: General requirements for the safety and performance of medical devices

ISO 13485: Medical device quality management system (core document for registration)

ISO 14971: Medical device risk management

Selected Product-Specific Standards

IVD Reagents: NCh 20916, ISO 23640, ISO 18113-2, ISO 15223-1
Active Medical Equipment: IEC 60601 series for medical electrical safety
Implantable Devices: ISO 25539 (cardiac stents), ISO 7206 (hip prostheses), ISO 5840 (heart valves)
Medical Software (SaMD): IEC 62304 Medical device software lifecycle processes

Enterprises may submit Chilean national NCh standards or equivalent current international standard certificates; both are accepted as compliance proof.

（三） Mandatory Notification System for Product Changes

After registration approval, any modifications to design, raw materials, manufacturing processes, intended use, labelling or performance must be actively notified to ISP. Alterations affecting safety or performance constitute major changes requiring full re-application for sanitary registration. ISP will issue further provisions defining the scope of major changes.

（四）Special Emergency Clause

During public health emergencies, Chile’s Ministry of Health may impose additional clinical and analytical performance requirements for IVD products.

四、Phased Transition Timetable

（一）24-month Transition Period (Mandatory Certification by 19 March 2028)

All Class IV high-risk implantable devices: cardiac stents, pacemakers, hip prostheses, cochlear implants, blood bags, insulin pumps and other implantable products.

（二）36-month Transition Period (Mandatory Certification by 19 March 2029)

All IVD in vitro diagnostic reagents (COVID-19, influenza, HPV, blood glucose, early pregnancy testing, etc.); radiology, radiotherapy, nuclear medicine, dialysis, ventilators, electrosurgical units, imaging software.

（三）Voluntary Early Registration Route (Beneficial for Enterprises)

Before the mandatory deadline, manufacturers may voluntarily submit registration applications to ISP. ISP is required to release complete registration technical guidance documents within 12 months of the decree’s publication (before 19 March 2027). Companies can launch applications in advance to secure market access ahead of competitors.

五、Key Practical Risk Avoidance Tips

Mandatory Appointment of Chilean Local Authorised Representative：Overseas manufacturers without local Chilean entities must appoint a local Chilean enterprise as legal responsible party to liaise with ISP, manage registration, adverse event reporting and product recalls. Full authorisation documentation requires Hague Apostille / consular legalisation.

Prepare Full Technical Documentation in Advance：Registration dossier checklist: ISO 13485 certificate, risk management report, biocompatibility report, electrical safety test report, clinical data / free sale certificate, Spanish-language labelling & IFUs, authorised representative agreement.

Spanish Mandatory for Labelling & Instructions：Product outer packaging, instructions and promotional materials must be in Spanish. Intended use, warnings, storage and operating procedures must fully align with registration submissions; exaggerated advertising is prohibited.

Stagger Registration Schedules to Prevent Application Bottlenecks：Implantable products under the 24-month transition have long review cycles and strict assessment; priority initiation is recommended.

IVD and imaging equipment have a 36-month window but require complex technical files; pre-review is advised within 1 year.

Ongoing Post-Market Vigilance Obligations：Certificate holders must maintain an adverse event monitoring system. Severe adverse reactions must be promptly reported to ISP, and enterprises shall cooperate with annual market surveillance.

六、Conclusion

As a key Latin American healthcare market, Decree No.25 marks the official arrival of universal mandatory registration for Chile’s medical device industry, covering the full spectrum of IVD products, implantable devices, large imaging equipment, home medical devices and medical software.

If you wish to know further details, please contact Wiselink Group!

As Latin America’s largest medical device market with the most mature regulatory framework, Brazil is a core strategic hub for Chinese medical device companies expanding into South America.

To celebrate Wiselink’s 6th Anniversary, we are launching a limited-time offer: from 18 June to 18 July, consultation service fees for all risk classes of medical devices targeting Brazil are offered at a 20% discount! New and existing clients are welcome to reach out for enquiries.

Previous：FDA Small Business Fee Waivers! Full Application Guide for FY2026 Next：Turkey: The Golden Eurasian Gateway – Practical Guide to Medical Device Registration

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.